Endoscopic Sleeve Gastroplasty Technique Comparison for Weight Loss

NCT06299644 | Not Yet Recruiting FDA Device

• 1 other identifier: 2023P003282
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity; Obesity, Morbid; Metabolic Disease; Weight, Body

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

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (10)

• Gastric Emptying

  Baseline, 6 month, 12 months

• Number of participants with improvement in fasting glucose

  Baseline, 6 months, 12 months

• Number of participants with improvement in Hemoglobin A1c (HgA1c %)

  Baseline, 6 months, 12 months

• Improvement in fasting lipids profile

  Baseline, 6 months, 12 months

• Number of participants with a change in ghrelin hormone values

  Baseline, 6 months, 12 months

Study Arms (2)

Belt and Suspenders Configuration

ACTIVE COMPARATOR

Endoscopic sleeve gastroplasty with the Endomina system creating proximal and distal gastric plications (belt and suspenders configuration).

Device: Endoscopic Sleeve Gastroplasty - Belt and Suspenders

Belt Configuration

ACTIVE COMPARATOR

Endoscopic sleeve gastroplasty with the Endomina system creating distal gastric plications (belt configuration).

Device: Endoscopic Sleeve Gastroplasty - Belt

Interventions

Endoscopic Sleeve Gastroplasty - Belt and Suspenders DEVICE

Endoscopic sleeve gastroplasty using belt and suspender plications.

Also known as: Belt and Suspenders ESG

Belt and Suspenders Configuration

Endoscopic Sleeve Gastroplasty - Belt DEVICE

Endoscopic sleeve gastroplasty using belt only plications.

Also known as: Belt ESG

Belt Configuration

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with 18-65 years of age
• BMI ≥ 30 kg/m2
• Capable of giving informed consent and available to return for follow-up visit

You may not qualify if:

• Untreated H. pylori infection
• Active gastric or duodenal ulceration
• Malignant or premalignant gastric diseases (such as intestinal metaplasia, high grade dysplasia, gastric adenocarcinoma, or gastrointestinal stromal tumor (GIST))
• Severe reflux esophagitis (Los Angeles Classification (LA) Grade C or D)
• Esophageal or gastric varices and/or portal hypertensive gastropathy
• Gastroparesis
• History of gastric surgery/endoscopic procedure
• Active psychological issues preventing participation in a lifestyle modification program
• Known history of endocrine disorders affecting weight (uncontrolled hypothyroidism)
• Severe coagulopathy
• Active smoking
• Substance abuse
• Serious health condition that increased risk of anesthesia and/or endoscopic procedure
• Pregnancy or lactation
• Patients who require Non-Steroidal Anti-inflammatory Drugs (NSAID) use

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• Endo Tools Therapeutics S.A.: collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (6)

• 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.

  PMID: 28445566 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.

  PMID: 37813705 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.

  PMID: 31932205 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.

  PMID: 31236722 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.

  PMID: 36053446 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.

  PMID: 32304011 BACKGROUND

MeSH Terms

Conditions

Obesity; Obesity, Morbid; Metabolic Diseases; Body Weight; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Christopher C Thompson, MD, MSc

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michele B Ryan, MS

CONTACT

617-525-8266; mryan@bwh.harvard.edu

Samantha Geltz

CONTACT

617-525-8266; sgeltz@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Endoscopy

Study Record Dates

• First Submitted: February 1, 2024
• First Posted: March 8, 2024
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, CSR
• Time Frame: 12 months after publication of results. Available for 10 years.
• Access Criteria: Formal written request to PI with research proposal/plan.

Locations

US (1)