About this trial
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.
Eligibility criteria
Qualifiers
BMI of 30 kg/m2 or greater, AND
regained at least 25% of the total weight lost after initial successful response to sleeve gastrectomy. defined as Excess Weight Loss (EWL) greater than 50% or Total Body Weight Loss (TBWL) exceeding 20%
Must have undergone SG at least three years before the time of enrollment
Age range: 22 - 60 years
Disqualifiers
Inadequate response to sleeve gastrectomy
Patients requiring exogenous insulin.
HbA1c > 8.5%
Pregnant or breast-feeding or intending to get pregnant during the study.
Trial design
Treatments tested in this trial
- Gastric Mucosal Ablation (GMA)
Treatment groups
Sponsors and collaborators
Dr. Christopher McGowan
Lead sponsor
True You Weight Loss
Sponsor institution