Trials / Recruiting
RecruitingNCT06671119
REvision of VSG with Ablation of the Mucosa Procedure
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 5 (estimated)
- Sponsor
- Dr. Christopher McGowan · Academic / Other
- Sex
- All
- Age
- 22 Years – 60 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
Obesity is a multifaceted chronic disease associated with substantial morbidity and mortality, leading to conditions like diabetes, cardiovascular diseases, and malignancies. Bariatric procedures, such as the sleeve gastrectomy, stand out as the current most effective long-term treatments for obesity. Despite its effectiveness, a significant number of patients experience weight regain during long-term follow-up. Endoscopic minimally invasive bariatric intervention has been proposed as a viable, safe, and effective option for the treatment of weight regain after SG. Gastric mucosal ablation (GMA), in particular, is hypothesized to be a safe and effective endoscopic revisional treatment for weight regain following sleeve gastrectomy based on previous positive pre-clinical and clinical studies. To investigate the feasibility, safety, and tolerability of GMA after sleeve gastrectomy, a single procedure is designed to ablate the gastric mucosa of the pseudo greater curvature created after the sleeve gastrectomy in a single endoscopic session. We hypothesize that endoscopic selective ablation of the gastric mucosa after sleeve gastrectomy is effective as a revisional treatment for weight regain and will result in significant metabolic improvements.
Conditions
- Obesity and Obesity-related Medical Conditions
- Obesity and Overweight
- Obesity Prevention
- Obesity Recidivism
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Gastric Mucosal Ablation (GMA) | Endoscopic Gastric Mucosal Ablation (GMA) after sleeve gastrectomy |
Timeline
- Start date
- 2024-12-01
- Primary completion
- 2026-05-01
- Completion
- 2026-05-01
- First posted
- 2024-11-04
- Last updated
- 2024-11-05
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT06671119. Inclusion in this directory is not an endorsement.