Registry for gastric fundus mucosal ablation to aid weight loss
A Multi-site, Prospective Registry of Patients Undergoing Gastric Fundal Mucosal Ablation at True You Weight Loss
This study is testing a procedure that aims to help people lose weight by reducing hunger hormones in their stomachs and will track how well it works over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | True You Weight Loss Academic / other |
| Locations | 1 site (Cary, North Carolina) |
| Trial ID | NCT06428617 on ClinicalTrials.gov |
What this trial studies
This study aims to create a multi-site, prospective registry to assess the clinical outcomes of patients who have undergone gastric fundus mucosal ablation at True You Weight Loss. The procedure targets the gastric fundus, which is responsible for producing ghrelin, a hormone that stimulates hunger. By reducing ghrelin production through mucosal ablation, the study seeks to help patients manage obesity more effectively. Participants will be monitored for weight changes and adverse events following the procedure, with a focus on long-term nutritional support and lifestyle modifications.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 with a BMI between 27 and 55 who are willing to adhere to lifelong dietary restrictions.
Not a fit: Patients with active psychological issues, eating disorders, or those who are pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly aid in weight loss and obesity management for patients.
How similar studies have performed: While this approach is innovative, similar studies targeting ghrelin reduction for weight loss have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥ 18 years and ≤ 65 years old 2. BMI ≥ 27 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 fundus mucosal ablation 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. Eating disorders including night eating syndrome (NES), bulimia, binge eating disorder, or compulsive overeating. 5. Patients with previous or current tobacco use 6. Patients with prior gastric surgery (e.g., vertical sleeve gastrectomy, gastric bypass, hiatal hernia repair, Nissen fundoplication, adjustable gastric band). 7. Patients on therapeutic anticoagulation or antithrombotics that cannot be interrupted for at least 12 weeks following GFMA. 8. Patients who cannot commit to 12 weeks of post-GMFA pharmacologic ulcer prophylaxis 9. At the discretion of the PI for subject safety
Where this trial is running
Cary, North Carolina
- 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.