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Endoscopic Sleeve Gastroplasty Technique Comparison for Weight Loss
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
🗓️ Study Start (Actual) 1 May 2025
🗓️ Primary Completion (Estimated) 1 July 2026
✅ Study Completion (Estimated) 31 December 2026
👥 Enrollment (Estimated) 10
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Boston, Massachusetts, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 18 Years to 65 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 1 February 2024
  • First Submitted that Met QC Criteria 6 March 2024
  • First Posted 8 March 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 26 July 2024
  • Last Update Posted 29 July 2024
  • Last Verified July 2024
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