RecruitingNot Applicable

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

United States200 participantsStarted 2024-06-01

Plain-language summary

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.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

✕. 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

What they're measuring

Percent Change in Total Body Weight Loss (TBWL) from Baseline

Timeframe: 12 Months

Trial details

NCT IDNCT06428617

SponsorTrue You Weight Loss

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2028-06

Contact for this trial

Chase Wooley, BS

919-336-4171 Chase@trueyouweightloss.com

View on ClinicalTrials.gov More Obesity trials