Ablation Registry (Combined Gastric Mucosal Ablation With Endoscopic Sleeve Gastroplasty for Weight Loss)
Recruiting now
Conditions studied: Obesity
In brief
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.
Key facts
- Study ID
- NCT06420700
- Run by
- True You Weight Loss
- People needed
- 100
- Starts
- 2024-01-31
- Expected to finish
- 2028-01-31
- Last updated by the study team
- 2024-05-22
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
- True You Weight Loss — Atlanta, Georgia, United States (enrolling)
- True You Weight Loss — Cary, North Carolina, United States (enrolling)
Full record on ClinicalTrials.gov
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