Endoscopic Gastric Mucosal Ablation (GMA) of Class III Obesity (NCT05574777) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Endoscopic Gastric Mucosal Ablation (GMA) of Class III Obesity
Brazil13 participantsStarted 2023-04-13
Plain-language summary
This study is intended to investigate safety and feasibility of a new weight loss technique called Gastric Mucosal Ablation (GMA) that does not require surgery, but can be achieved using an endoscopic procedure.
Previous studies have suggested that weight loss after vertical sleeve gastrectomy (VSG) is partly due to the removal of normal stomach tissue suspected of having hormonal function. The study will investigate the minimally invasive treatment of obesity Class III participants by means of argon plasma coagulation (APC) in combination with waterjet submucosal injection using HybridAPC.
As primary endpoint device or procedure related occurrence of complications according to Clavien-Dindo classification will be determined.
After signing the informed consent the doctor and research team will determine if the participant meets all requirements for this study. If a participant is confirmed to be a suitable candidate additional tests will be performed prior to the first application of GMA to assess the health status of the participant prior to treatment. During the screening and baseline visit the medical history and the medications of the participant will be reviewed.
After the treatments the participants will be followed for up to 6 months to assess the outcome of the GMA procedure.
Who can participate
Age range21 Years – 75 Years
SexALL
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Inclusion criteria
✓. Male or female patients with class III obesity (BMI = 40 and BMI \> 40)
✓. Age 21 - 75 yrs.
✓. Treatment naïve for bariatric surgery or endoscopic bariatric therapy
✓. Agree to avoid any use of weight loss medications such as Meridia, Saxenda, Januvia, Xenical, or over the counter weight loss medications or supplements throughout the study.
✓. Women of childbearing potential (WOCBP) must agree to use acceptable contraception methods.
✓. Agree not to donate blood during their participation in the study.
✓. Able to comply with study requirements and understand and sign the Informed Consent Form.
✓. Stable weight defined as a fluctuation of less than 5% for at least 3 months prior to screening visit.
Exclusion criteria
✕. 1\) Patients requiring exogenous insulin.
What they're measuring
1
Rate of complications related to the device or procedure