NCT06428617Recruiting
Fundus Ablation Registry (Gastric Fundus Mucosal Ablation for Weight Loss)
A Multi-site, Prospective Registry of Patients Undergoing Gastric Fundal Mucosal Ablation at True You Weight Loss
Source: ClinicalTrials.gov · Last updated 10 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The purpose of this study is to construct a multi-site, prospective registry to evaluate the clinical outcomes of patients who have undergone gastric fundus mucosal ablation at True You Weight Loss.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 200 (estimated)
- First submitted
- 20 May 2024
- Start date
- 1 Jun 2024
- Primary completion date
- Jun 2028
- Lead sponsor
- True You Weight Loss
- Diseases
- Obesity
- NCT number
- NCT06428617
What you commit to
- Study type: Observational
- Planned participants: 200
- From 1 Jun 2024 to the primary completion date, Jun 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with previous or current tobacco use
- Patients with prior gastric surgery (e.g., vertical sleeve gastrectomy, gastric bypass, hiatal hernia repair, Nissen fundoplication, adjustable gastric band).
Other illness
- Eating disorders including night eating syndrome (NES), bulimia, binge eating disorder, or compulsive overeating.
- Patients who cannot commit to 12 weeks of post-GMFA pharmacologic ulcer prophylaxis
Other
- 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 on therapeutic anticoagulation or antithrombotics that cannot be interrupted for at least 12 weeks following GFMA.
- At the discretion of the PI for subject safety
Who the study is looking for
- Age ≥ 18 years and ≤ 65 years old
- BMI ≥ 27 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 fundus mucosal ablation procedure at True You Weight Loss regardless of the research
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| True You Weight Loss Coordinator of this site? Confirm its status | Cary | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.