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Search / Trial NCT06299644

Endoscopic Sleeve Gastroplasty Technique Comparison for Weight Loss

Launched by BRIGHAM AND WOMEN'S HOSPITAL · Mar 6, 2024

Trial Information

Current as of June 26, 2025

Not yet recruiting

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

ClinConnect Summary

This clinical trial is exploring a new method for helping people lose weight through a procedure called endoscopic sleeve gastroplasty. The researchers want to see if a specific way of placing stitches in the stomach can lead to more effective weight loss. They will compare two different stitching patterns to find out which one helps patients lose more weight overall.

To participate in this study, individuals need to be between 18 and 65 years old and have a body mass index (BMI) of 30 or higher, which indicates obesity. Participants should be able to understand the study and attend follow-up visits. However, certain health conditions, like untreated infections or serious stomach issues, may prevent someone from joining. If eligible, participants can expect to learn more about their weight loss journey and receive support throughout the process. The study is not yet recruiting participants, but it aims to provide valuable insights into effective weight loss techniques.

Gender

ALL

Eligibility criteria

  • 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

About Brigham And Women's Hospital

Brigham and Women's Hospital (BWH) is a leading academic medical center located in Boston, Massachusetts, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. As an integral part of the Partners HealthCare system, BWH combines cutting-edge medical education with a focus on patient-centered care, fostering an environment that promotes groundbreaking clinical trials across various specialties. The hospital is dedicated to translating scientific discoveries into effective treatments, making significant contributions to the fields of cardiovascular medicine, oncology, and women's health, among others. With a robust infrastructure for research and a collaborative approach, BWH aims to improve patient outcomes and enhance the overall quality of healthcare.

Locations

Boston, Massachusetts, United States

Patients applied

0 patients applied

Trial Officials

Christopher C Thompson, MD, MSc

Principal Investigator

Brigham and Women's Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported