Recruiting

Gastric Fundus Ablation

Sponsor:

True You Weight Loss

Code:

NCT06428617

Conditions

Obesity

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Study Details

Brief 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.

Conditions

Obesity

Study ID

NCT06428617

Start date

Jun 1, 2024

Status verified date

May, 2024

Completion date

Jun, 2028

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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 Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Percent Change in Total Body Weight Loss (TBWL) from Baseline [ Time Frame: 12 Months ]

Central Contacts and Locations

Locations

True You Weight Loss

Recruiting

Cary, North Carolina, United States, 27513

Contacts

Principal Investigator:

Christopher McGowan, MD

More Information

Sponsor

True You Weight Loss

Last update posted

Apr 10, 2025

Last verified

May, 2024

Keywords

  • obesity
  • ghrelin
  • hunger
  • ablation
  • True You Weight Loss
  • hunger hormone
  • fundus
  • fundus ablation
  • fundic ablation
  • GFMA

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by True You Weight Loss on 2025-04-10.