Fundus Ablation Registry (Gastric Fundus Mucosal Ablation for Weight Loss)
Recruiting · NCT06428617 · Observational (researchers observe without assigning treatment) · Lead sponsor: True You Weight Loss
View the official record on ClinicalTrials.gov →What this trial 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.
Who can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- Age ≥ 18 years and ≤ 65 years old
- BMI ≥ 27 and ≤55 kg/m²
- Willingness to comply with the substantial lifelong dietary restrictions required by the procedure.
- Ability to give informed consent
- Women of childbearing potential (i.e., not post-menopausal or surgically sterilized) must agree to use adequate birth control methods.
- Those who plan to receive the gastric fundus mucosal ablation procedure at True You Weight Loss regardless of the research
Exclusion criteria
- Patients that do not meet eligibility requirements for the study as per the Principal Investigator's standard selection criteria
- Active psychological issues preventing participation in a life-style modification program as determined by a psychologist.
- Patients who are pregnant or breast-feeding.
- Eating disorders including night eating syndrome (NES), bulimia, binge eating disorder, or compulsive overeating.
- Patients with previous or current tobacco use
- Patients with prior gastric surgery (e.g., vertical sleeve gastrectomy, gastric bypass, hiatal hernia repair, Nissen fundoplication, adjustable gastric band).
- Patients on therapeutic anticoagulation or antithrombotics that cannot be interrupted for at least 12 weeks following GFMA.
- Patients who cannot commit to 12 weeks of post-GMFA pharmacologic ulcer prophylaxis
- At the discretion of the PI for subject safety
Where it is running
1 location listed across 1 US state.
- True You Weight Loss - Cary, North Carolina, United States