Непереносимость лактозы
05/08/2024
Меню
Allurion Gastric Balloon has been developed for many years and is the world’s first and only swallowable gastric balloon that does not require anesthesia, surgery and endoscopy in its application. Continuing its development efforts to be innovative and the best, Allurion has reached over 120,000 applications in the world to date.
We have compiled for you all the studies and results in the medical literature that have been done so far in the world on the Allurion swallowable gastric balloon and the Allurion Program.
Studies that will contribute to development are still ongoing, including in our clinic. Published and completed clinical studies are included in this article.
By following these studies, we can find answers to many questions about the use of the innovative Allurion gastric balloon.
The studies were classified into various groups.
Abbreviations:
WL: Weight Lost
TBWL: Total Body Weight Lost
AE: Adverse Effects
SAE: Severe Adverse Effects
BMI: Body Mass Index
ILI: Intensive Lifestyle Intervention Program
Sample size (N): Usually used for Number Of Patients
IGB: Intragastric Balloon
AGBS: Allurion Gastric Balloon System
WC: Waist Circumference
PIGB: Procedureless Intragastric Balloon
1. | |
CITATION | Ienca R, Oyola C, Jarallah M, et al. The swallowable Gastric Balloon Program: Global experience in 3,716 patients. |
SAMPLE SIZE (N) | 3716 |
METHODS | Multicenter 3 continents 9 countries 26 centers 4 months follow-up |
DEMOGRAPHICS | 70.5% female 29.5% male Mean age: 41.2 years Mean weight: 95 kg Mean BMI: 34.1 kg/m² |
RESULTS | Mean WL: 13.5 kg Mean TBWL: 14.1% Significant improvement in all metabolic parameters AE rate 2.74% SAE rate 0.17% |
CONCLUSIONS | The largest study of the Allurion Gastric Balloon Program confirms a TBWL of 14.1%, significantly improved metabolic parameters, and consistent safety in diverse, global populations. The unique Virtual Care Suite facilitates close follow-up to optimize safety and efficacy. |
REFERENCE | |
2. | |
CITATION | Genco A, Giardiello C, Lucchese M, et al. Effects of New Procedureless Intragastric Balloon (Allurion ®) on Metabolic Syndrome and Pre- Diabetes: Italian Group’s Experience on 324 Patients with Overweight and Obesity. |
SAMPLE SIZE (N) | 324 |
METHODS | Multicenter |
DEMOGRAPHICS | 59% female 41% male Mean age: 45 years Mean weight: 104 kg Mean BMI: 36.8 kg/m² |
RESULTS | Mean WL: 14.3 kg Mean TBWL: 13.75% Positive effect on glucose metabolism No SAEs |
CONCLUSIONS | Allurion is a safe and effective in inducing weight loss and results in a significant reduction in obesity- related metabolic diseases including metabolic syndrome and pre-diabetes |
REFERENCE | |
3. | |
CITATION | Ienca R, Rosa M, Selvaggio C, et al. Expanding the reach of Intragastric Balloons; First multicenter results of Allurion Balloon in non-core user group. |
SAMPLE SIZE (N) | 64 |
METHODS | Multicenter |
DEMOGRAPHICS | 61% female 39% male Mean age : 45.1 ± 10.7 years Mean BMI: 35 ± 4.6 kg/m² Mean weight: 101.4 ± 19.6 kg |
RESULTS | Mean TBWL : 16 ± 6% Change in BMI : 5.7 ± 2.6 kg/m² TG and LDL significantly decreased 1 balloon removal due to intolerance No SAEs |
CONCLUSIONS | These data demonstrate that the Allurion Balloon, as administered by “non-core” clinicians, is not only safe but can also produce above average efficacy results.The extension of the IGB management to other specialists opens access to a greater number of patients. |
REFERENCE | SOARD, 2018, 14, S99-S196 |
1. | |
CITATION | Raftopoulos Y, Tsechpenakis A, Davidson M E, Chapin K, Reardon C, McMillian U The Swallowable Gastric Balloon Significantly Enhances an Intensive Lifestyle Intervention Program for Weight Loss: Final Short and Long Term Results up to 1 Year after Balloon Placement. |
SAMPLE SIZE (N) | 553 |
METHODS | ILI for both groups included a structured curriculum-based nutritional, exercise and behavior modification program. WL results are recorded every month 1Y follow-up |
DEMOGRAPHICS | Mean BMI (Allurion): 36.2 ± 5.2 kg/m² Mean BMI (ILI): 36.8 ± 5 kg/m² |
RESULTS | At 4 months, TBWL: Allurion group: 14.9% ILI group: 6.3% At 12 months, TBWL: Allurion group: 16.9% ILI group: 7.9% Percentage of Allurion patients achieving: 5% TBWL (98.1% vs. 29.7%), 10% TBWL (83.4% vs. 8.2%) 20% TBWL (18.3% vs. 0.05%) at 16 weeks were all significantly greater (p<.0001). 94.7%, 71% and 39.5% of Allurion patients maintained a 5%, 10% and 20% TBWL at 52 weeks. |
CONCLUSIONS | Allurion IGB remains an independent and highly significant contributor of weight loss when added to a 1-year intensive lifestyle intervention. Furthermore, even after passage of the Allurion balloon, 93% of weight loss achieved was maintained at 1 year after placement. |
REFERENCE | ASMBS 2021 |
1. | |
CITATION | Ienca R, Giardiello C, Schiano Di Cola R, et al. The Evolution of the Allurion Program for Long-Term Weight Loss: From Virtual Monitoring to a Virtual Care Suite |
SAMPLE SIZE (N) | 522 |
METHODS | Multicenter 9 international obesity centers Patients followed for 1 year after balloon passage +VCS |
DEMOGRAPHICS | 64% female 36% male Mean weight: 101.9 kg Mean BMI 35.9 kg/m² |
RESULTS | At 4 months: Mean WL: 14.4 kg Mean TBWL: 13.9% At 1 year after Balloon passage: Mean WL: 14.2 kg Mean TBWL: 13.4% 96% maintenance of %TBWL AE 1.6% SAE 0.2% |
CONCLUSIONS | The Allurion Program demonstrated excellent short and long-term efficacy for weight loss with very few adverse events |
REFERENCE | European Congress on Obesity, May 2022 — LBP4.16 |
2. | |
CITATION | Ernesti I, Formiga A, Giardiello C, Genco A, Sukkar S, Zappa M, Rovati M, Rosa M, Watanabe M Effects of a New Procedureless Intragastric Balloon on Weight Loss and Metabolic Syndrome: Multicenter Registry Experience with 1 Year Follow- up. |
SAMPLE SIZE (N) | 324 |
METHODS | Multicenter |
DEMOGRAPHICS | 59% female 41% male Mean age: 45 years Mean weight: 104 kg Mean BMI: 36.8 kg/m² |
RESULTS | After 16 weeks: Mean WL: 14.3 kg TBWL: 13.75% BMI reduction: 5 kg/m² At 1-year follow-up: TBWL : 10.1% BMI reduction : 3.7 kg/m² The overall incidence of the metabolic syndrome at baseline, 4 months and 1 year after balloon excretion was 43.5%, 15.7% and 17.9% respectively. 73% sustained weight- loss No SAE |
CONCLUSIONS | Allurion, a procedureless intragastric balloon treatment, appears to be safe and effective in inducing TBWL of 13.75% at 4 months that was still maintained at 10.1% one year following balloon excretion (73% sustained weight- loss). In addition, there was a significant reduction in obesity- related metabolic syndrome that reduction persisted a year later. |
REFERENCE | ASMBS 2021 |
3. | |
CITATION | Ienca R., Caballero A., Giardiello C., Pagan A., Rosa M., Badiuddin F., Junejia G., Formiga A., Murcia S. Long-Term Efficacy of the Allurion Gastric Balloon System: An International Multicenter Study |
SAMPLE SIZE (N) | 509 |
METHODS | 1 year follow-up 9 international obesity centers |
DEMOGRAPHICS | 63% female 37% male Mean weight: 102.6 ± 21.3 kg Mean BMI: 35.9 ± 5.8 kg/m² |
RESULTS | At 4 Months: Weight loss: 14.4 ± 7.7 kg TBWL: 13.9 ± 6.4% BMI loss : 5.1± 2.6 g/m² Metabolic parameters improved significantly At 1 year: Weight loss: 14.1 ± 11.7 kg TBWL: 13.3 ± 9.9% BMI loss: 4.9 ± 4.0 kg/m² AEs: Intolerance 1.2%, gastric dilation 0.2%, gastritis 0.2% and gastric perforation requiring laparoscopic repair 0.2% |
CONCLUSIONS | AGBS demonstrated excellent short- and long-term weight loss results. Very few adverse events occurred during the treatment. “Virtual follow-up” enhanced weight loss during AGBS treatment. Continued “Virtual follow- up” after balloon passage enabled a significant weight loss maintenance. This resulted in a 13.9% TBWL at 4 months and 13.3% TBWL 1-year after balloon passage, a 95% maintenance of %TBWL. |
REFERENCE | TOS Obesity Week 2020 / Oral 068 |
1. | |
CITATION | Ienca R., Caballero A., Kolmer S., Juneja G., Murcia S., Al Kuwari M., Quartararo G., Rosa M., Karlson R., Giardiello C. Sequential Allurion Balloon Treatment 1- Year Weight Loss Results Approximate Bariatric Surgery Results. |
SAMPLE SIZE (N) | 42 |
METHODS | 2 sequential balloons 1 year follow-up 9 international obesity centers |
DEMOGRAPHICS | 76% female 24% male Mean age: 42.2 ± 11.2 years At 1st balloon placement: Mean weight: 102.4 ± 19.2 kg Mean BMI: 36.8 ± 5.4 kg/m² At 2nd balloon placement: Mean weight: 89.1 ± 18.0 kg Mean BMI: 31.9 ± 4.7 kg/m² |
RESULTS | At 4 months (1st balloon): Mean weight loss : 14.7 ± 4.4 kg TBWL: 14.4 ± 3.6% Change in BMI : 4.9 ± 2 kg/m² Sequential balloon resulted in additional: WL: 8.8 ± 5.7 kg TBWL: 10.0 ± 6.5% From baseline: Total WL: 22.0 ± 9.0 kg TBWL: 22.8 ± 8.8% BMI decrease: 8.1 kg/m² After two sequential balloons, %TBWL ≥10%, ≥20% and ≥30% was achieved in 97.6%, 64.7% and 26.1% of patients. 0 SAE, and one patient had a planned endoscopic balloon removal due to history of appendicitis. |
CONCLUSIONS | Sequential Allurion Balloon treatment is safe and effective if additional weight loss is indicated following the passage of the first Allurion Balloon. The mean TBWL of 22.8% at the end of one-year approaches results seen with weight loss surgery. |
REFERENCE | TOS Obesity Week 2020 / Poster 384 |
1. | |
CITATION | Ienca R, Rosa M, Pagan Pomar A, Hansoulle J, Caballero A. Emerging Role of the New Swallowable Gastric Balloon in Type 2 Diabetes and Prediabetes Treatment |
SAMPLE SIZE (N) | 226 |
METHODS | Multicenter |
DEMOGRAPHICS | 60% female 40% male 78 with diabetes 148 with pre-diabetes |
RESULTS | Weight loss 17.7 ± 7.1 kg HbA1c values in the diabetesgroup decreased from 7.0 ± 0.6% to 5.5 ± 1.1% (p<.0001) HbA1c values in the prediabetes group decreased from 6.0 ± 0.2% to 4.9± 0.7% (p<.0001) |
CONCLUSIONS | AGBS is safe and effective for patients withoverweight and obesity with both Type 2 Diabetes and Prediabetes. Highly significant reduction in HbA1c was achieved in just 4 months of treatment. Average HbA1c in patients withdiabetes and prediabetes reverted to normal values. Further studies will determine long-term results. |
REFERENCE | TOS Obesity Week 2021 / Poster 114 |
2. | |
CITATION | Ienca R., Caballero A., Giardiello C., Schiano di Cola R., Schiavo L., Pagan A., Al Kuwari M., Al Samman Zouaghi S., Turro R., Urritia L., Kayassa A., Al Jarallah M. Innovative Swallowable Gastric Balloon for Weight Loss Studied in Patients Younger Than Eighteen Years: A Multicenter Study. |
SAMPLE SIZE (N) | 42 |
METHODS | Multicenter |
DEMOGRAPHICS | Age: 13.5-17.5 years Mean weight: 98.8 kg |
RESULTS | At 4 months: |
CONCLUSIONS | Allurion is safe and effective for the treatment of obesity in patients aged less than 18 years. It may be considered a very useful therapeutic option for this difficult to manage category of patients. |
REFERENCE | ASMBS 2021 |
3. | |
CITATION | Rajkukmar S and Raftopoulos Y.
|
SAMPLE SIZE (N) | 232 |
METHODS | Single center |
DEMOGRAPHICS | Mean age: 42.6 years |
RESULTS | BMI ≥ 40 kg/m2 versus BMI < 40 kg/m2 |
CONCLUSIONS | The Allurion Balloon is safe and effective in patients with a BMI ≥ 40 kg/m2, achieving over 20% TBWL at 6 months. |
REFERENCE | ASMBS 2023 |
1. | |
CITATION | Raftopoulos Y, A Tsechpenakis The Swallowable Gastric Balloon: A Telehealth Approach with Best- in- Class Weight-loss Results. An open randomized trial with remote follow-up through asynchronous or synchronous communication. |
SAMPLE SIZE (N) | 140 |
METHODS | Group A: asynchronous follow-up Group B: synchronous follow-up Patients in both groups were not seen in person (except for placement) |
DEMOGRAPHICS | Mean BMI: 36.7 kg/m² |
RESULTS | TBWL at 16 weeks: 14.9% %TBWL was significantly better in group B at: 16 weeks (15.6 vs. 13.5, p=.004), 20 weeks (18.5 vs 13.6, p=.0003, n=19 vs 47) 24 weeks (18.7 vs 13.5, p=.0001, n=23 vs 39) No SAEs were observed. |
CONCLUSIONS | Allurion’s unique non-invasive profile and its Bluetooth connected scale and smartphone app can achieve safe and effective weight- loss by remote follow-up alone without physical visits. Synchronous patient communication achieved an excellent mean TBWL of 18.7% at 24 weeks |
REFERENCE | ASMBS 2021 |
1. | |
CITATION | Ienca, R, Ayuso, L, Shahin, M Swallowable intragastric balloon program (Allurion program) and GLP1 agonist combined treatment for obesity: an international multicenter study. |
SAMPLE SIZE (N) | 181 |
METHODS | Data of patients treated with a combination of the Allurion balloon program and Saxenda® retrospectively analyzed from 3 international multidisciplinary obesity centers. Treatment started with the Allurion balloon, and later Saxenda® was added. All patients were followed for at least 6 months. 2331 total patients with a BMI ≥ 27kg/m2 received the swallowable IGB programme. Of these 181 (7.7%) received this combination therapy |
DEMOGRAPHICS | 145F / 36M Mean baseline weight: 94.8 ±21kg Mean baseline BMI: 33.7±6.2kg/m2 |
RESULTS | After 4 months of balloon treatment, WL, %TBWL, %EWL and BMIL were 13.1 ± 7kg, 13.9 ± 7.7%, 74.3 ± 57.1% and 4.5 ±1.4kg/m2 respectively. Saxenda® therapy added between week 4-16 after balloon placement. Average duration of drug treatment 4.1±2.2 months. Total length of combined treatment was: 7.76 ± 2.1 months Main reasons for adding Saxenda®: unsatisfactory weight loss 52.6%, reduction of balloon induced satiety 29%, to further boost weight loss in successful patients 16%. At the end of the treatment with Saxenda® WL, %TBWL, %EWL and BMIL were 18.1 ± 12.1 kg, 18.7 ± 12%, 99.4 ± 84.9% and 6.4 ± 5.9kg/m2 respectively. |
CONCLUSIONS | The Allurion balloon program delivers excellent weight loss in patients with overweight and obesity. In case of suboptimal adherence with the program and for patients that are aiming to further boost the results of treatment, the combination with the GLP1 agonist, Saxenda®, is safe and effective in improving results. |
REFERENCE | ECO 2023 |
1. | |
CITATION | Ramai, D., Singh, J., Mohan, B. P., Madedor, O., Brooks, O. W., Barakat, M., Ofosu, A., Khan, S. R., Chandan, S., Dhindsa, B., Dhaliwal, A., Facciorusso, A., McDonough, S., & Adler, D. G. (2021). Influence of the Elipse Intragastric Balloon on Obesity and Metabolic Profile: A Systematic Review and Meta-Analysis. Journal of clinical gastroenterology, 55(10), 836–841. |
SAMPLE SIZE (N) | 2152 |
METHODS | Meta-analysis 7 studies Raftopoulos 2017 Alsabah 2018 Machytka 2017 Jamal 2019 Al-Subaie 2017 Genco 2018 Ienca 2020 |
DEMOGRAPHICS | Baseline BMI: 32.1 to 38.6 kg/m² |
RESULTS | Mean TBWL 12% Early deflation rate 1.8% |
CONCLUSIONS | This meta-analysis demonstrates that the Allurion intragastric balloon is a safe, effective, and tolerable device for weight loss and obesity with a minimal side effect profile |
REFERENCE | https://doi.org/10.1097/MCG.00000 00000001484 |
2. | |
CITATION | Vantanasiri, K., Matar, R., Beran, A., & Jaruvongvanich, V. (2020). The Efficacy and Safety of a Procedureless Gastric Balloon for Weight Loss: a Systematic Review and Meta-Analysis. Obesity surgery, 30(9), 3341–3346. |
SAMPLE SIZE (N) | 2013 |
METHODS | Meta-analysis 6 studies Ienca 2019 Raftopoulos 2019 Espinet 2019 Jamal 2019 Alsabah 2017 Machytka 2016 |
DEMOGRAPHICS | Baseline BMI: 30.6-36.2 kg/m² |
RESULTS | TBWL (4M): 12.75% TBWL (1Y): 10.94% 1 SBO 1 gastric perforation Intolerance requiring balloon removal: 2.3% |
CONCLUSIONS | This meta-analysis demonstrates that the Allurion intragastric balloon is a safe device offering an effective weight loss that warrants further studies for its long- term weight loss outcomes. Severe adverse events are rare, and the rate of early removal is low. |
REFERENCE | https://doi.org/10.1007/s11695-020-04522-3 |
3. | |
CITATION | Ienca, R., Al Jarallah, M., Caballero, A., Giardiello, C., Rosa, M., Kolmer, S., Sebbag, H., Hansoulle, J., Quartararo, G., Zouaghi, S. A. S., Juneja, G., Murcia, S., Turro, R., Pagan, A., Badiuddin, F., Dargent, J., Urbain, P., Paveliu, S., di Cola, R. S., Selvaggio, C., … Al Kuwari, M. (2020). The Procedureless Elipse Gastric Balloon Program: Multicenter Experience in 1770 Consecutive Patients. Obesity surgery, 30(9), 3354–3362. |
SAMPLE SIZE (N) | 1770 |
METHODS | 19 centers Physical follow-up visits |
DEMOGRAPHICS | 71% female 29% male Mean age : 38.8 ± 12 years Mean Weight: 94.6 ± 18.9 kg Mean BMI: 34.4 ± 5.3 kg/m² |
RESULTS | Mean weight loss : 13.5 ± 5.8 kg TBWL: 14.2 ± 5% Change in BMI : 4.9 ± 2 kg/m² All metabolic parameters significantly decreased 52 (2.9%) intolerance 11 (0.6%) early deflations 4 (0.2%) were endoscopically removed after discovery of contraindications 3 (0.17%) small bowel obstructions (previous version of Allurion Balloon) 1 (0.06%) gastric dilation |
CONCLUSIONS | The Allurion Balloon demonstrated an excellent safety profile. The balloon also exhibited remarkable efficacy with 14.2% TBWL and improvement across all metabolic parameters |
REFERENCE | https://doi.org/10.1007/s11695- 020-04539-8 |
1. | |
CITATION | Palermo, M., & Davrieux, C. F. (2023). Swallowable Intragastric Balloon: First Consecutive Experience in Argentina. Journal of laparoendoscopic & advanced surgical techniques. Part A, 33(2), 146–149. |
SAMPLE SIZE (N) | 153 |
METHODS | Single-center (Argentina) 6 months follow up |
DEMOGRAPHICS | 78% female 22% male Mean age: 39 years Mean BMI: 29.5 kg/m² |
RESULTS | Mean TBWL 12% at 4 months AE reported: abdominal pain, nausea, vomiting, headache, reflux, constipation and diarrhea. |
CONCLUSIONS | Effective, safe, and well tolerated |
REFERENCE | https://doi.org/10.1089/lap.2022.03 40 |
2. | |
CITATION | Taha, O., Abdelaal, M., Asklany, A., Alaa, M., Belal, S., El Assal, I., Shahin, M., Abubasha, A., & Elbanhawy, D. (2021). Outcomes of a Swallowable Intragastric Balloon (Elipse™) on 96 Overweight and Obese Patients. Obesity surgery, 31(3), 965–969. |
SAMPLE SIZE (N) | 96 |
METHODS | Retrospective analysis Single-center (Egypt) |
DEMOGRAPHICS | 71% female 29% male Mean age: 28.9 years Mean weight: 92.7 kg Mean BMI: 33.6 kg/m² |
RESULTS | TBWL at 16 weeks: 12.1% Improvements in Triglycerides, LDL cholesterol, HbA1c (p<0.0001) Intolerance requiring balloon removal: 3.1% Early balloon deflation (<90 days): 1.1% No SAEs |
CONCLUSIONS | The swallowable gastric balloon can be safely and successfully swallowed, with consistent weight loss and clinical improvement in factors related to metabolic syndrome |
REFERENCE | https://doi.org/10.1007/s11695- 020-05086-y |
3. | |
CITATION | Jamal, M. H., Almutairi, R., Elabd, R., AlSabah, S. K., Alqattan, H., & Altaweel, T. (2019). The Safety and Efficacy of Procedureless Gastric Balloon: a Study Examining the Effect of Elipse Intragastric Balloon Safety, Short and Medium Term Effects on Weight Loss with 1-Year Follow-Up Post-removal. Obesity surgery, 29(4), 1236–1241. |
SAMPLE SIZE (N) | 106 |
METHODS | Single-center (Kuwait) 1 year post excretion follow-up |
DEMOGRAPHICS | 77% female 23% male Mean age: 31.3 years Mean weight: 92.2 kg Mean BMI: 34.3 kg/m² |
RESULTS | 90/106 patients successfully followed-up (1y) TBWL (3M): 10.9% TBWL (1Y) : 7.9% Change in BMI (3M): 3.7 kg/m² Change in BMI (1Y): 2.95 kg/m² 6 removals due to intolerance 1 small bowel obstruction 3 early deflations |
CONCLUSIONS | Allurion IGBs are effective, safe, and feasible non-invasive method for weight loss |
REFERENCE | https://doi.org/10.1007/s11695- 018-03671-w |
4. | |
CITATION | Alsabah, S., Al Haddad, E., Ekrouf, S., Almulla, A., Al-Subaie, S., & Al Kendari, M. (2018). The safety and efficacy of the procedureless intragastric balloon. Surgery for obesity and related diseases : official journal of the American Society for Bariatric Surgery, 14(3), 311–317. |
SAMPLE SIZE (N) | 135 |
METHODS | Multicenter (Kuwait) 4 months follow-up |
DEMOGRAPHICS | 82% female 18% male Mean age: 33.5 years Mean BMI: 33.7 kg/m² Mean weight: 88.8kg |
RESULTS | At 4 months: Mean WL: 13kg Mean BMI loss: 4.9 kg/m² Mean TBWL: 15.1% 1 SBO |
CONCLUSIONS | This study aimed to evaluate the safety and effectiveness of the Allurion Balloon in the largest population studied as of date. It was also able to demonstrate that it swallowed, filled, imaged, and passed. In addition, it effectively aided in weight loss, showing promising results. |
REFERENCE | https://doi.org/10.1016/j.soard.2017.12.001 |
5. | |
CITATION | Al-Subaie, S., Khalifa, S., Buhaimed, W., & Al-Rashidi, S. (2017). A prospective pilot study of the efficacy and safety of Elipse intragastric balloon: A single- center, single-surgeon experience. International journal of surgery (London, England), 48, 16–22. |
SAMPLE SIZE (N) | 51 |
METHODS | Single-center (Kuwait) 4 months duration |
DEMOGRAPHICS | 92% female 8% male Mean age: 33.6 (18-65) years Mean WT: 83.9 ± 12.3 kg Mean BMI: 32.1 (27.3-39.7) kg/m² Mean WC: 95.3 ± 9.2 cm |
RESULTS | Total weight loss: 8.84 kg TBWL: 10.44% Change in BMI: 3.42 kg/m² Total WC reduction: 8.62 cm 5 removals due to intolerance 1 early deflation No SAEs Overall satisfaction above average |
CONCLUSIONS | These data proves that Allurion is safe and effective for weight loss. Nevertheless, some limitations were observed that need to be overcome for better outcomes. |
REFERENCE | https://doi.org/10.1016/j.ijsu.2017.1 0.001 |
6. | |
CITATION | Ernesti I, Ienca R, Basciani S, Mariani S, Genco A (2018) Effect of A New Swallowable Intragastric Balloon (Elipse™) on Weight Loss and Metabolic Syndrome. J Obes Nutr Disord: JOND-120. International journal of surgery (London, England), 48, 16–22. |
SAMPLE SIZE (N) | 42 |
METHODS | Single-center (Italy) Physical follow-up visits |
DEMOGRAPHICS | 69% female 31% male Mean age: 47.2 ± 10.3 years Mean WT: 110.5 ± 21.9 kg Mean BMI: 39.2 ± 6.7 kg/m² WC: 123.5 ± 16.9 cm |
RESULTS | Mean weight loss : 12.9 kg TBWL: 11.9% Change in BMI: 4.5 kg/m² WC: 111 ± 16.2 cm Significant reduction in major comorbidities: blood pressure, WC, triglycerides, blood glucose and HOMA-IR index. No complications |
CONCLUSIONS | The main finding of the present study was a significant BMI reduction and Metabolic syndrome remission rate within 4 months of treatment instead of 6 months, as happens in other balloons |
REFERENCE | DOI: 10.29011/JOND-120.100020 |
7. | |
CITATION | Genco, A., Ernesti, I., Ienca, R., Casella, G., Mariani, S., Francomano, D., Soricelli, E., Lorenzo, M., & Monti, M. (2018). Safety and Efficacy of a New Swallowable Intragastric Balloon Not Needing Endoscopy: Early Italian Experience. Obesity surgery, 28(2), 405–409. |
SAMPLE SIZE (N) | 38 |
METHODS | Single-center (Italy) Phone follow-up |
DEMOGRAPHICS | 74% female 26% male Mean age: 46.4 ± 10.6 years Mean WT: 109.7 ± 21.9 kg Mean BMI: 38.6 ± 6.7 kg/m² |
RESULTS | Mean weight loss: 12.7 kg TBWL: 11.6% Change in BMI: 4.2 kg/m² Significant reduction in major comorbidities: blood pressure, WC, triglycerides, blood glucose and HOMA-IR index. No complication during balloon passage. 37 normal stool excretion, 1 endoscopic removal. |
CONCLUSIONS | The results of this study on 38 consecutive patients demonstrate that the Allurion™Balloon is safe, effective, and very well accepted by patients. |
REFERENCE | https://doi.org/10.1007/s11695- 017-2877-1 |
8. | |
CITATION | Machytka, E., Gaur, S., Chuttani, R., Bojkova, M., Kupka, T., Buzga, M., Giannakou, A., Ioannis, K., Mathus-Vliegen, E., Levy, S., & Raftopoulos, I. (2017). Elipse, the first procedureless gastric balloon for weight loss: a prospective, observational, open- label, multicenter study. Endoscopy, 49(2), 154–160. |
SAMPLE SIZE (N) | 34 |
METHODS | Multicenter (Czech republic & Greece) Follow-up every 2 weeks |
DEMOGRAPHICS | 68% female 32% male Mean age: 42 (18-59) years Mean BMI: 34.8 kg/m² (27-40) Mean weight: 101.9 kg (73-134) |
RESULTS | TBWL: 10.0% BMI Loss: 3.9 kg/m² WC reduction: 8.4 cm Reduction in HbA1c: 0.16% Mean LDL reduction: 9.7 mg/dL Mean TG reduction: 16.4 mg/dL SBP and DBP reduction: 9.6mmHg and 5.8mmHg Overall quality of life, physical function, self-esteem, sexual life, public distress, and work-related quality of life significantly improved. No SAEs, all AEs were expected and normal |
CONCLUSIONS | These results demonstrate clinically significant weight loss with the Allurion Program, the first procedureless gastric balloon. The weight loss was similar to that seen in previous studies of endoscopically placed balloons. In addition, Allurion therapy led to improvements in waist circumference, several metabolic parameters, and overall quality of life. |
REFERENCE | https://doi.org/10.1055/s-0042- 119296 |
9. | |
CITATION | Raftopoulos, I., & Giannakou, A. (2017). The Elipse Balloon, a swallowable gastric balloon for weight loss not requiring sedation, anesthesia or endoscopy: a pilot study with 12- month outcomes. Surgery for obesity and related diseases : official journal of the American Society for Bariatric Surgery, 13(7), 1174–1182. |
SAMPLE SIZE (N) | 12 |
METHODS | Single-center (Athens, Greece) 1Y follow-up |
DEMOGRAPHICS | 58% female 42% male Mean age: 41 years Mean BMI: 35.9 kg/m² Mean weight: 103.5 kg Mean WC: 117.6 cm |
RESULTS | 4 months Mean TBWL: 14.6% 12 months Mean TBWL: 5.9% Quality of life was significantly improved at excretion and 12 months. No SAE reported |
CONCLUSIONS | This study is the first to demonstrate 12-month efficacy and performance outcomes of the Allurion Balloon. |
REFERENCE | https://doi.org/10.1016/j.soard.2017.02.016 |
1. | |
CITATION | Mital, S., & Nguyen, H. V. (2021). Cost-effectiveness of procedure- less intragastric balloon therapy as substitute or complement to bariatric surgery. PloS one, 16(7), e0254063. |
SAMPLE SIZE (N) | N/A |
METHODS | Practice economics Cost effectiveness comparison of procedureless intragastric balloons (PIGB), gastric bypass/sleeve gastrectomy, Gastric balloon as a bridge to gastric bypass/sleeve gastrectomy and no treatment. |
DEMOGRAPHICS | N/A |
RESULTS | Gastric balloon as a bridge to bariatric surgery is less costly and more effective than bariatric surgery alone as it helps to achieve a lower post-operative BMI. Of the six strategies, PIGB as a bridge to sleeve gastrectomy is the most cost-effective. While PIGB alone is not cost- effective compared with bariatric surgery, it is cost-effective compared with no treatment. |
CONCLUSIONS | PIGB can yield cost savings and improve health outcomes if used as a bridge to bariatric surgery and is cost-effective as a stand-alone treatment for patients lacking access or unwilling to undergo surgery |
REFERENCE | https://doi.org/10.1371/journal.pone.0254063 |
1. | |
CITATION | Ienca, R., Giardiello, C., Scozzarro, A., di Cola, R. S., Di Lorenzo, N., Juneja, G., Lopez, G., & Badiuddin, (2019). Improving Nausea and Vomiting Post-Elipse Balloon: a Novel Single-Dose Regimen of 300 mg Netupitant/0.5 mg Palonosetron Hydrochloride. Obesity surgery, 29(9), 2952–2956. |
SAMPLE SIZE (N) | 30 |
METHODS | Patients received Akynzeo at placement |
DEMOGRAPHICS | 70% female 30% male Mean weight: 97.8 kg Mean BMI 34.7 kg/m² |
RESULTS | 4/30 (13%) reported vomiting on days 1, 2, and 3; 9/30 (30%) reported nausea higher than score 4 on days 1, 2, and 3; 8/30 (26.6%) reported gastric pain higher than score 4 on days 1, 2, and 3. |
CONCLUSIONS | In our experience, the use of a single-pill netupitant / palonosetron resulted to be very easy to administer and effective in reducing vomiting, nausea, and gastric pain in 87%, 70%, and 73.4% patients respectively, ameliorating the post Allurion™ placements symptoms safely. |
REFERENCE | https://doi.org/10.1007/s11695- 019-03937-x |
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