Metabolic Disease, Obesity, Obesity, Morbid, Weight, Body
Conditions
Keywords
Endoscopic Bariatric and Metabolic Therapies (EBMT), Endoscopic Bariatric Therapies (EBT), Gastric emptying, Endoscopic Suturing, endoscopic sleeve gastroplasty (ESG), Weight Loss, Bariatric Endoscopy, Weight Management, Endoscopic plication, Gastric plication
Brief summary
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.
Detailed description
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.
Interventions
DEVICEEndoscopic Sleeve Gastroplasty - Belt and Suspenders
Endoscopic sleeve gastroplasty using belt and suspender plications.
DEVICEEndoscopic Sleeve Gastroplasty - Belt
Endoscopic sleeve gastroplasty using belt only plications.
Sponsors
Endo Tools Therapeutics S.A.
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with 18-65 years of age 2. BMI ≥ 30 kg/m2 3. Capable of giving informed consent and available to return for follow-up visit
Exclusion criteria
1. Untreated H. pylori infection 2. Active gastric or duodenal ulceration 3. Malignant or premalignant gastric diseases (such as intestinal metaplasia, high grade dysplasia, gastric adenocarcinoma, or gastrointestinal stromal tumor (GIST)) 4. Severe reflux esophagitis (Los Angeles Classification (LA) Grade C or D) 5. Esophageal or gastric varices and/or portal hypertensive gastropathy 6. Gastroparesis 7. History of gastric surgery/endoscopic procedure 8. Active psychological issues preventing participation in a lifestyle modification program 9. Known history of endocrine disorders affecting weight (uncontrolled hypothyroidism) 10. Severe coagulopathy 11. Active smoking 12. Substance abuse 13. Serious health condition that increased risk of anesthesia and/or endoscopic procedure 14. Pregnancy or lactation 15. Patients who require Non-Steroidal Anti-inflammatory Drugs (NSAID) use
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent TWL (%TWL) | Baseline, 6 months, 12 months | Change in the percent total weight loss from baseline at 6 and 12 months. |
| Adverse Events | 6 months, 12 months | Presence of adverse events that develop post-procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with improvement in Hemoglobin A1c (HgA1c %) | Baseline, 6 months, 12 months | Change in HgA1c laboratory values from baseline at 6 and 12 months post-procedure |
| Improvement in fasting lipids profile | Baseline, 6 months, 12 months | Change in fasting lipids laboratory values from baseline at 6 and 12 months post-procedure |
| Number of participants with a change in ghrelin hormone values | Baseline, 6 months, 12 months | Change in ghrelin laboratory values from baseline at 6 and 12 months post-procedure |
| Obesity-related comorbidities - hypertension | Baseline, 6 months, 12 months | Change in hypertension diagnosis/status via change in blood pressure measurements (systolic and diastolic mm Hg) at 6 months and 12 months from baseline |
| Gastric Emptying | Baseline, 6 month, 12 months | Comparison of gastric emptying rate using Gastric Emptying Breath Test (GEBT) from baseline to 6 months and 12 months post-procedure |
| Obesity-related comorbidities - change in pre-diabetes/diabetes concomitant medications | Baseline, 6 months, 12 months | Change in diabetes/pre-diabetes diagnosis/status via change in diabetes medications dosages (mg) at 6 months and 12 months from baseline |
| Obesity-related comorbidities - pre-diabetes/diabetes | Baseline, 6 months, 12 months | Change in diabetes/pre-diabetes diagnosis/status via change in HgA1c measurements (%) at 6 months and 12 months from baseline |
| Obesity-related comorbidities - gastroesophageal reflux (GERD) | Baseline, 6 months, 12 months | 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 |
| Obesity-related comorbidities - change in hypertension concomitant medications | Baseline, 6 months, 12 months | Change in hypertension diagnosis/status via change blood pressure related medication dosage (mg) at 6 months and 12 months from baseline |
| Number of participants with improvement in fasting glucose | Baseline, 6 months, 12 months | Change in fasting glucose laboratory values from baseline at 6 and 12 months post-procedure |
Countries
United States
Contacts
Primary ContactMichele B Ryan, MS
Backup ContactSamantha Geltz
Outcome results
None listed