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