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

Last updated: April 7, 2025
Sponsor: True You Weight Loss
Overall Status: Active - Recruiting

Phase

N/A

Condition

Obesity

Weight Loss

Diabetes Prevention

Treatment

N/A

Clinical Study ID

NCT06428617
RGT-002
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 bythe 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 YouWeight Loss regardless of the research

Exclusion

Exclusion Criteria:

  1. Patients that do not meet eligibility requirements for the study as per thePrincipal Investigator's standard selection criteria

  2. Active psychological issues preventing participation in a life-style modificationprogram as determined by a psychologist.

  3. Patients who are pregnant or breast-feeding.

  4. Eating disorders including night eating syndrome (NES), bulimia, binge eatingdisorder, or compulsive overeating.

  5. Patients with previous or current tobacco use

  6. Patients with prior gastric surgery (e.g., vertical sleeve gastrectomy, gastricbypass, hiatal hernia repair, Nissen fundoplication, adjustable gastric band).

  7. Patients on therapeutic anticoagulation or antithrombotics that cannot beinterrupted 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

Total Participants: 200
Study Start date:
June 01, 2024
Estimated Completion Date:
June 30, 2028

Study Description

Obesity is a chronic, progressive, multifactorial disease that contributes to increasing morbidity, mortality, and economic costs worldwide. The oxyntic mucosa of the gastric fundus is the principal site for the production of the orexigenic peptide hormone ghrelin. Ghrelin activates hunger-promoting pathways of the hypothalamus and opposes the satiety-promoting actions of other gastrointestinal peptides, leading to calorie-ingesting behaviors and weight gain. A method to reduce ghrelin production and decrease fundal compliance and capacity through mucosal devitalization may confer benefit to patients seeking treatment for obesity. This is a multi-site, prospective registry of patients who have elected to undergo Gastric Fundus Mucosal Ablation (GFMA) at a True You Weight Loss site in Cary, NC or Atlanta, GA. Study participants will consist of up to 200 adult patients of ages 18 to 65 years old who have elected to undergo GFMA at a True You Weight Loss site (Cary, NC or Atlanta, GA) prior to their involvement in the study. Participants that meet the criteria below will be deemed eligible for participation after consultation with the study investigator. Study participants will receive follow-up care according to standard of care practices, regardless of their involvement in the research study. Standard of care nutritional practice includes a comprehensive lifestyle program with long-term nutritional support and monitoring. Patient weights and adverse events will be collected at each visit. Adverse events will be communicated to medical team members in between dedicated visits. We aim to establish a multi-site, prospective registry to longitudinally describe GMFA in adults with obesity, including patient characteristics, weight loss, improvement in weight-related medical conditions, and adverse events.

Connect with a study center

  • True You Weight Loss

    Atlanta, Georgia 30342
    United States

    Site Not Available

  • True You Weight Loss

    Cary, North Carolina 27513
    United States

    Active - Recruiting

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