Clinical trial
Fundus Ablation Registry (Gastric Fundus Mucosal Ablation for Weight Loss)
Recruiting now · Not applicable · 1 countries · Registry ID NCT06428617
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 gastric fundus mucosal ablation 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 ≥ 27 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 fundus mucosal ablation 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. Eating disorders including night eating syndrome (NES), bulimia, binge eating disorder, or compulsive overeating. 5. Patients with previous or current tobacco use 6. Patients with prior gastric surgery (e.g., vertical sleeve gastrectomy, gastric bypass, hiatal hernia repair, Nissen fundoplication, adjustable gastric band). 7. Patients on therapeutic anticoagulation or antithrombotics that cannot be interrupted for at least 12 weeks following GFMA. 8. Patients who cannot commit to 12 weeks of post-GMFA pharmacologic ulcer prophylaxis 9. At the discretion of the PI for subject safety
Treatments and study arms
The registry does not list a named intervention.
Primary outcomes
Percent Change in Total Body Weight Loss (TBWL) from Baseline12 Months
Measured percent change in total body weight over time following Gastric Fundus Mucosal Ablation. %TBWL = (pre-op weight - post op body weight) / (pre-op weight) \* 100 measured as a percentage.
Study locations
1 locations were listed when this page was built. The first 40 are shown.
True You Weight Loss🇺🇸 Cary, North Carolina, United States
Chase Wooley, BSContact
Shannon Casey, BS, MSContact
Christopher McGowan, MDPrincipal Investigator