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

Description

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 Overview

Study Details

Study overview

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.

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

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

Condition
Obesity
Intervention / Treatment

-

Contacts and Locations

Cary

True You Weight Loss, Cary, North Carolina, United States, 27513

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

True You Weight Loss,

Study Record Dates

2028-06