Clinical trial

Ablation Registry (Combined Gastric Mucosal Ablation With Endoscopic Sleeve Gastroplasty for Weight Loss)

Recruiting now · Not applicable · 1 countries · Registry ID NCT06420700

Recruiting nowNot applicableObservational

What this study is about

The purpose of this study is to construct a multi-site, prospective registry to evaluate the clinical outcomes of patients who have undergone combined gastric mucosal ablation with endoscopic sleeve gastroplasty at True You Weight Loss.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 65 Years

SexAll

Healthy volunteersNot accepted

ConditionObesity

Full registry criteria

Inclusion Criteria: 1. Age ≥ 18 years and ≤ 65 years old 2. BMI ≥ 28 and ≤55 kg/m² 3. Willingness to comply with the substantial lifelong dietary restrictions required by the procedure. 4. Ability to give informed consent 5. Women of childbearing potential (i.e., not post-menopausal or surgically sterilized) must agree to use adequate birth control methods. 6. Those who plan to receive the gastric mucosal ablation with ESG procedure at True You Weight Loss regardless of the research Exclusion Criteria: 1. Patients that do not meet eligibility requirements for the study as per the Principal Investigator's standard selection criteria 2. Active psychological issues preventing participation in a life-style modification program as determined by a psychologist. 3. Patients who are pregnant or breast-feeding. 4. Patients currently taking weight-loss medications or other therapies for weight loss within the prior 6 months. 5. Eating disorders including night eating syndrome (NES), bulimia, binge eating disorder, or compulsive overeating. 6. At the discretion of the PI for subject safety

Treatments and study arms

Combined gastric mucosal ablation with endoscopic sleeve gastroplasty

Procedure

Combined gastric mucosal ablation with endoscopic sleeve gastroplasty in the treatment of adults with obesity

Primary outcomes

Percent Change in Total Body Weight Loss (TBWL) from Baseline12 Months

Measured percent change in total body weight over time following combined Gastric Mucosal Ablation. %TBWL = (pre-op weight - post op body weight) / (pre-op weight) \* 100 measured as a percentage.