Ablation Registry (Combined Gastric Mucosal Ablation With Endoscopic Sleeve Gastroplasty for Weight Loss)
Recruiting · NCT06420700 · Observational (researchers observe without assigning treatment) · Lead sponsor: True You Weight Loss
View the official record on ClinicalTrials.gov →Interventions studied
Combined gastric mucosal ablation with endoscopic sleeve gastroplasty
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 combined gastric mucosal ablation with endoscopic sleeve gastroplasty 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 ≥ 28 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 mucosal ablation with ESG 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.
- Patients currently taking weight-loss medications or other therapies for weight loss within the prior 6 months.
- Eating disorders including night eating syndrome (NES), bulimia, binge eating disorder, or compulsive overeating.
- At the discretion of the PI for subject safety
Where it is running
2 locations listed across 2 US states.
- True You Weight Loss - Atlanta, Georgia, United States
- True You Weight Loss - Cary, North Carolina, United States