REvision of VSG with Ablation of the Mucosa Procedure

Part of paid clinical trials in Cary, North Carolina.

Sponsor
Dr. Christopher McGowan
Study ID
NCT06671119
Status
Recruiting
Apply to this trial

Conditions

  • Obesity Prevention
  • Obesity Recidivism
  • Obesity and Obesity-related Medical Conditions
  • Obesity and Overweight

Eligibility Criteria

Sex
ALL
Age
22 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Gastric Mucosal Ablation (GMA) — DEVICE
    Endoscopic Gastric Mucosal Ablation (GMA) after sleeve gastrectomy

Study Details

The purpose of this study is to evaluate the feasibility, safety, and tolerability of endoscopic selective gastric mucosal ablation (GMA) using argon plasma coagulation after sleeve gastrectomy. In this study, GMA will be performed on patients who have experienced weight regain following an initial successful response to sleeve gastrectomy.

Key Dates

Start date
Dec 31, 2024
Status verified
Oct 2024
Primary completion
May 31, 2026
Completion
May 31, 2026

Study Design

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

Arms

  • Experimental: Gastric Mucosal Ablation (GMA) following sleeve gastrectomy
    Subjects will undergo endoscopic Gastric Mucosal Ablation (GMA) following sleeve gastrectomy. 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: 6 Months ]

Central Contacts

Locations (1)

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

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By research site
True You Weight Loss· Cary, NC

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