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

Recruiting now

Conditions studied: Obesity

In brief

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.

Key facts

Study ID

NCT06428617

Run by

True You Weight Loss

People needed

200

Starts

2024-06-01

Expected to finish

2028-06-01

Last updated by the study team

2025-04-10

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.
• Eating disorders including night eating syndrome (NES), bulimia, binge eating disorder, or compulsive overeating.
• 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).
• Patients on therapeutic anticoagulation or antithrombotics that cannot be interrupted for at least 12 weeks following GFMA.
• Patients who cannot commit to 12 weeks of post-GMFA pharmacologic ulcer prophylaxis
• At the discretion of the PI for subject safety

Where it is running

• True You Weight Loss — Cary, North Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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