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| Name | Class |
|---|---|
| Endo Tools Therapeutics S.A. | INDUSTRY |
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The Investigators propose suture plication placement at the distal gastric body drives a significant portion of weight loss in endoscopic sleeve and sutures only need to be placed in the distal gastric body. Therefore, in this pilot study, the investigators aim to compare "belt" with "belt and suspenders" plication pattern using the Endomina system to determine percent total weight loss.
Obesity is a major global health concern. In the US, from 1999 through 2020, the prevalence of obesity has increased from 30.5% to 41.9%. Obesity, defined as the body mass index of more than 30 kg/m2, increases the risk of metabolic diseases and has become the leading cause of death including cardiovascular disease, stroke and cancers.
At present, obesity treatment ranges from lifestyle modification, pharmacotherapy, endoscopic to surgical intervention. Though bariatric surgery has proven to be the most effective treatment in terms of weight loss, it still carries the complication rates of 0.6% - 4.9%.
Endoscopic Bariatric and Metabolic Therapy (EBMT) has emerged as an alternative minimally invasive approach for the patients with morbid obesity with the body mass index (BMI) of 30 - 40 kg/m2. Endoscopic sleeve gastroplasty (ESG) involves placing sutures inside the stomach using an endoluminal full-thickness suturing device. This allows for gastric volume reduction and impaired gastric motility, which results in weight loss. Recent meta-analysis demonstrated ESG, using OverStitch suturing device, percent total weight loss (%TWL) of 16.09 - 16.43% at 12 months after procedure and a serious adverse event rate of 1 - 2.26%. With favorable outcomes and lower complication rates compared to bariatric surgery, ESG has been growing in popularity and increasingly performed worldwide. Other EBT cleared by the U.S. Food and Drug Administration for full thickness tissue approximation include the Incisionless Operating Platform endoscopic plication (USGI Medical, San Clemente, Calif, USA), and Endomina® (Endo Tools Therapeutic, Gosselies, Belgium) which creates gastric plications.
Currently, there is no standardization regarding suturing patterns. One suture pattern for gastric plication that has been used is the "belt and suspenders" pattern whereby plications sutures are placed in the distal gastric body along the width (belt) and mid/proximal gastric body (suspenders). This allows for gastric shortening and reduction in gastric volume. It is suspected this would also alter gastric motility. The distal gastric plications placed near the antrum would result in a disruption of gastric motility; decreased gastric motility would result in decrease gastric emptying and longer satiety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Belt and Suspenders Configuration | Active Comparator | Endoscopic sleeve gastroplasty with the Endomina system creating proximal and distal gastric plications (belt and suspenders configuration). |
|
| Belt Configuration | Active Comparator | Endoscopic sleeve gastroplasty with the Endomina system creating distal gastric plications (belt configuration). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic Sleeve Gastroplasty - Belt and Suspenders | Device | Endoscopic sleeve gastroplasty using belt and suspender plications. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent TWL (%TWL) | Change in the percent total weight loss from baseline at 6 and 12 months. | Baseline, 6 months, 12 months |
| Adverse Events | Presence of adverse events that develop post-procedure | 6 months, 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Gastric Emptying | Comparison of gastric emptying rate using Gastric Emptying Breath Test (GEBT) from baseline to 6 months and 12 months post-procedure | Baseline, 6 month, 12 months |
| Number of participants with improvement in fasting glucose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michele B Ryan, MS | Contact | 617-525-8266 | mryan@bwh.harvard.edu | |
| Samantha Geltz | Contact | 617-525-8266 | sgeltz@bwh.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Christopher C Thompson, MD, MSc | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28445566 | Background | Ibrahim AM, Ghaferi AA, Thumma JR, Dimick JB. Variation in Outcomes at Bariatric Surgery Centers of Excellence. JAMA Surg. 2017 Jul 1;152(7):629-636. doi: 10.1001/jamasurg.2017.0542. | |
| 37813705 | Background | Docimo S Jr, Aylward L, Albaugh VL, Afaneh C, El Djouzi S, Ali M, Altieri MS, Carter J; American Society for Metabolic and Bariatric Surgery Clinical Issues Committee. Endoscopic sleeve gastroplasty and its role in the treatment of obesity: a systematic review. Surg Obes Relat Dis. 2023 Nov;19(11):1205-1218. doi: 10.1016/j.soard.2023.08.020. Epub 2023 Sep 16. No abstract available. |
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De-identified data will be shared with other researchers upon written request to the PI. If PI approves of the research plan, data will be released after an Institutional Data Sharing Agreement is in place.
12 months after publication of results. Available for 10 years.
Formal written request to PI with research proposal/plan.
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D009767 | Obesity, Morbid |
| D008659 | Metabolic Diseases |
| D001835 | Body Weight |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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|
| Endoscopic Sleeve Gastroplasty - Belt | Device | Endoscopic sleeve gastroplasty using belt only plications. |
|
|
Change in fasting glucose laboratory values from baseline at 6 and 12 months post-procedure
| Baseline, 6 months, 12 months |
| Number of participants with improvement in Hemoglobin A1c (HgA1c %) | Change in HgA1c laboratory values from baseline at 6 and 12 months post-procedure | Baseline, 6 months, 12 months |
| Improvement in fasting lipids profile | Change in fasting lipids laboratory values from baseline at 6 and 12 months post-procedure | Baseline, 6 months, 12 months |
| Number of participants with a change in ghrelin hormone values | Change in ghrelin laboratory values from baseline at 6 and 12 months post-procedure | Baseline, 6 months, 12 months |
| Obesity-related comorbidities - hypertension | Change in hypertension diagnosis/status via change in blood pressure measurements (systolic and diastolic mm Hg) at 6 months and 12 months from baseline | Baseline, 6 months, 12 months |
| Obesity-related comorbidities - change in hypertension concomitant medications | Change in hypertension diagnosis/status via change blood pressure related medication dosage (mg) at 6 months and 12 months from baseline | Baseline, 6 months, 12 months |
| Obesity-related comorbidities - change in pre-diabetes/diabetes concomitant medications | Change in diabetes/pre-diabetes diagnosis/status via change in diabetes medications dosages (mg) at 6 months and 12 months from baseline | Baseline, 6 months, 12 months |
| Obesity-related comorbidities - pre-diabetes/diabetes | Change in diabetes/pre-diabetes diagnosis/status via change in HgA1c measurements (%) at 6 months and 12 months from baseline | Baseline, 6 months, 12 months |
| Obesity-related comorbidities - gastroesophageal reflux (GERD) | Change in GERD diagnosis/status via change in proton pump inhibitor (PPI) or related medications for treatment of GERD at 6 months and 12 months | Baseline, 6 months, 12 months |
| 31932205 | Background | Singh S, Hourneaux de Moura DT, Khan A, Bilal M, Ryan MB, Thompson CC. Safety and efficacy of endoscopic sleeve gastroplasty worldwide for treatment of obesity: a systematic review and meta-analysis. Surg Obes Relat Dis. 2020 Feb;16(2):340-351. doi: 10.1016/j.soard.2019.11.012. Epub 2019 Dec 10. |
| 31236722 | Background | Li P, Ma B, Gong S, Zhang X, Li W. Efficacy and safety of endoscopic sleeve gastroplasty for obesity patients: a meta-analysis. Surg Endosc. 2020 Mar;34(3):1253-1260. doi: 10.1007/s00464-019-06889-6. Epub 2019 Jun 24. |
| 36053446 | Background | Beran A, Matar R, Jaruvongvanich V, Rapaka BB, Alalwan A, Portela R, Ghanem O, Dayyeh BKA. Comparative Effectiveness and Safety Between Endoscopic Sleeve Gastroplasty and Laparoscopic Sleeve Gastrectomy: a Meta-analysis of 6775 Individuals with Obesity. Obes Surg. 2022 Nov;32(11):3504-3512. doi: 10.1007/s11695-022-06254-y. Epub 2022 Sep 2. |
| 32304011 | Background | Jalal MA, Cheng Q, Edye MB. Systematic Review and Meta-Analysis of Endoscopic Sleeve Gastroplasty with Comparison to Laparoscopic Sleeve Gastrectomy. Obes Surg. 2020 Jul;30(7):2754-2762. doi: 10.1007/s11695-020-04591-4. |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |