Ablation Registry (Combined Gastric Mucosal Ablation With Endoscopic Sleeve Gastroplasty for Weight Loss)
Sponsored by True You Weight Loss
About this study
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.
Obesity is a chronic disease state driven by the imbalance of caloric intake and expenditure and mediated by multiple central and peripheral pathways that may serve as targets for therapeutic interventions. The endoscopic sleeve gastroplasty (ESG) is a per oral gastric remodeling technique that employs full-thickness suturing to imbricate the stomach along the greater curvature to achieve a restricted, sleeve-like configuration. While the ESG recapitulates the configuration of a gastric sleeve, it has not yet been shown to achieve as robust weight loss outcomes compared to the laparoscopic sleeve gastrectomy (LSG). A major difference between ESG and LSG is that the former does not involve the gastric fundus. The proximal stomach, and the fundus in particular, produces ghrelin, the only kno…
Where this study is enrolling (2)
- I'm interested
True You Weight Loss
Atlanta, Georgia
- I'm interested
True You Weight Loss
Cary, North Carolina
Who can participate
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
Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.
Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.
Trial data sourced from ClinicalTrials.gov.