Endoscopic Gastric Mucosal Ablation as a Primary Obesity Therapy (NCT05486338) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Endoscopic Gastric Mucosal Ablation as a Primary Obesity Therapy
United States15 participantsStarted 2023-09-05
Plain-language summary
This study is intended to investigate safety and feasibility of a new weight loss technique called endoscopic 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 by means of argon plasma coagulation (APC) in combination with waterjet submucosal injection using HybridAPC.
As primary objective total body weight loss (TBWL) will be determined as body weight difference at the 6 months follow up (FU) visit after the last treatment session in comparison to the body weight prior to the initial treatment.
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 12 months to assess the outcome of the GMA procedure.
Who can participate
Age range22 Years – 60 Years
SexALL
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Inclusion criteria
✓. Male or females patients in the range of class I to class III obesity (BMI ≥ 30 to ≤ 40 with obesity-related comorbidity or BMI \> 40 to BMI ≤ 45).
✓. Age 22 - 60 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, Duromine 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.
✕. Pregnant or breast-feeding or intending to get pregnant during the study.
✕. Unwilling or unable to complete the Visual Analogue Scale for pain assessment, patient questionnaires, or comply with study visits and other study procedures as required per protocol.
✕. History of diabetic ketoacidosis or hyperosmolar nonketotic coma.
✕. Probable insulin production failure, defined as fasting C-Peptide serum \< 1 ng/mL (333 pmol/l).
✕. Previous use of any types of insulin for \> 1 month (at any time, except for treatment of gestational diabetes).
✕. Change in diabetic treatment within the last three months.