Combining gastric mucosal ablation with endoscopic sleeve gastroplasty for weight loss
A Multi-site, Prospective Registry of Patients Undergoing Combined Gastric Mucosal Ablation With Endoscopic Sleeve Gastroplasty at True You Weight Loss
This study is testing a new weight loss approach that combines two procedures to see if it helps people lose more weight than standard methods.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | True You Weight Loss Academic / other |
| Locations | 2 sites (Atlanta, Georgia and 1 other locations) |
| Trial ID | NCT06420700 on ClinicalTrials.gov |
What this trial studies
This study aims to create a multi-site, prospective registry to assess the clinical outcomes of patients undergoing combined gastric mucosal ablation with endoscopic sleeve gastroplasty at True You Weight Loss. The procedure involves a unique approach to obesity treatment by targeting the gastric fundus, which produces ghrelin, a hormone linked to increased appetite. By evaluating the effectiveness of this combined technique, the study seeks to determine if it can lead to better weight loss outcomes compared to traditional methods. Participants will be monitored for their weight loss progress and related health metrics over time.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 65 with a BMI between 28 and 55 who are willing to adhere to lifelong dietary restrictions.
Not a fit: Patients with active psychological issues, eating disorders, or those currently on weight-loss medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective weight loss solutions for patients struggling with obesity.
How similar studies have performed: While the approach of combining gastric mucosal ablation with endoscopic sleeve gastroplasty is innovative, previous studies have shown varying success with similar techniques, indicating potential but untested outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Atlanta, Georgia and 1 other locations
- True You Weight Loss — Atlanta, Georgia, United States (Recruiting)
- True You Weight Loss — Cary, North Carolina, United States (Recruiting)
Study contacts
- Study coordinator: Chase Wooley, BS
- Email: Chase@trueyouweightloss.com
- Phone: (919) 336-4171
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.