RecruitingPhase not listed

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 65 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

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 gastric fundus mucosal ablation at True You Weight Loss.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Official eligibility 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

Study sites (1)

NC