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Ablation Registry (Combined Gastric Mucosal Ablation With Endoscopic Sleeve Gastroplasty for Weight Loss)
RECRUITINGSponsored by True You Weight Loss
Actively Recruiting
SponsorTrue You Weight Loss
Started2024-01-31
Est. completion2028-01-31
Eligibility
Age18 Years – 65 Years
Healthy vol.Accepted
Locations2 sites
View on ClinicalTrials.gov →
NCT06420700
Summary
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.
Eligibility
Age: 18 Years – 65 YearsHealthy volunteers accepted
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
Conditions2
ObesityWeight Loss
Locations2 sites
Georgia
1 siteNorth Carolina
1 siteTrue You Weight Loss
Cary, North Carolina, 27513
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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.
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Actively Recruiting
SponsorTrue You Weight Loss
Started2024-01-31
Est. completion2028-01-31
Eligibility
Age18 Years – 65 Years
Healthy vol.Accepted
Locations2 sites
View on ClinicalTrials.gov →
NCT06420700