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Fundus Ablation Registry (Gastric Fundus Mucosal Ablation for Weight Loss)

RecruitingObservational study

A Multi-site, Prospective Registry of Patients Undergoing Gastric Fundal Mucosal Ablation at True You Weight Loss

Who can join

Ages 18 to 65 · All sexes

Full 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

About the 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.

Sponsor: True You Weight Loss · Participants: 200 · Started: Jun 1, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06428617

Locations in the U.S.

North CarolinaTrue You Weight Loss, Cary

Conditions

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.