Endoscopic Sleeve Gastroplasty Technique Comparison for Weight Loss

Obesity Clinical Trial

Official title:

Endoscopic Sleeve Gastroplasty Technique Comparison for Weight Loss Using the Endomina Plicating Device: A Randomized Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06299644
• Other study ID #: 2023P003282
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2025
• Est. completion date: December 31, 2026

Study information

• Verified date: March 2024
• Source: Brigham and Women's Hospital
• Contact: Michele B Ryan, MS
• Phone: 617-525-8266
• Email: mryan[@]bwh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: December 31, 2026
• Est. primary completion date: July 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Metabolic Disease
• Metabolic Diseases
• Obesity
• Obesity, Morbid
• Weight Loss
• Weight, Body

Intervention

Device:
• Endoscopic Sleeve Gastroplasty - Belt and Suspenders
Endoscopic sleeve gastroplasty using belt and suspender plications.
• Endoscopic Sleeve Gastroplasty - Belt
Endoscopic sleeve gastroplasty using belt only plications.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	Endo Tools Therapeutics S.A.

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent TWL (%TWL)	Change in the percent total weight loss from baseline at 6 and 12 months.	Baseline, 6 months, 12 months
Primary	Adverse Events	Presence of adverse events that develop post-procedure	6 months, 12 months
Secondary	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
Secondary	Number of participants with improvement in fasting glucose	Change in fasting glucose laboratory values from baseline at 6 and 12 months post-procedure	Baseline, 6 months, 12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

•   Centers for Disease Control and Prevention - Adult Obesity Facts