MAINTAIN (Mucosal AblatIoN Therapy After INcretins)

Part of paid clinical trials in Cary, North Carolina.

Sponsor
Dr. Christopher McGowan
Study ID
NCT06734312
Status
Recruiting
Apply to this trial

Conditions

  • Ablation Techniques
  • GLP-1
  • Obesity Prevention
  • Obesity Recidivism
  • Obesity and Obesity-related Medical Conditions
  • Obesity and Overweight

Eligibility Criteria

Sex
ALL
Age
21 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Gastric Fundal Mucosal Ablation (GFMA) — DEVICE
    Endoscopic Gastric Fundal Mucosal Ablation (GFMA) after discontinuation of GLP-1 therapy

Study Details

The purpose of this study is to assess the effect of gastric fundal mucosal ablation (GFMA) on weight trajectory following discontinuation of once-weekly semaglutide or tirzepatide in adults with obesity. In this study, GFMA will be performed on patients who have experienced \> 10% weight loss with GLP-1 therapy and who plan to discontinue use of GLP-1 medications for the duration of the study.

Key Dates

Start date
Jan 1, 2025
Status verified
Jan 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Gastric Fundal Mucosal Ablation (GFMA) following discontinuation of GLP-1 therapy
    Subjects will undergo endoscopic Gastric Fundal Mucosal Ablation (GFMA) following following discontinuation of GLP-1 therapy. This will be performed by an experienced endoscopist specialized in bariatric endoscopy in a single endoscopic session.

Primary Outcome Measure

Percent Change in Total Body Weight Loss (TBWL) from Baseline [ Time Frame: 12 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
True You Weight LossCaryNorth Carolina27513
Chase Wooley, BS
[email protected]
(984) 345-2988
Shannon Casey, MS
[email protected]
(919) 391-7843
Christopher McGowan, MD, MSCR (PRINCIPAL_INVESTIGATOR)
True You Weight LossCaryNorth Carolina27513
Shannon Casey, MS
[email protected]
919-391-7843
Chase Wooley, BS
[email protected]
984-345-2988
Christopher McGowan, MD, MSCR (PRINCIPAL_INVESTIGATOR)

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By research site
True You Weight Loss· Cary, NC

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