Phase
Condition
Obesity
Weight Loss
Diabetes Prevention
Treatment
N/AClinical Study ID
Ages 18-65 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 bythe 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 YouWeight Loss regardless of the research
Exclusion
Exclusion Criteria:
Patients that do not meet eligibility requirements for the study as per thePrincipal Investigator's standard selection criteria
Active psychological issues preventing participation in a life-style modificationprogram as determined by a psychologist.
Patients who are pregnant or breast-feeding.
Eating disorders including night eating syndrome (NES), bulimia, binge eatingdisorder, or compulsive overeating.
Patients with previous or current tobacco use
Patients with prior gastric surgery (e.g., vertical sleeve gastrectomy, gastricbypass, hiatal hernia repair, Nissen fundoplication, adjustable gastric band).
Patients on therapeutic anticoagulation or antithrombotics that cannot beinterrupted for at least 12 weeks following GFMA.
Patients who cannot commit to 12 weeks of post-GMFA pharmacologic ulcer prophylaxis
At the discretion of the PI for subject safety
Study Design
Study Description
Connect with a study center
True You Weight Loss
Atlanta, Georgia 30342
United StatesSite Not Available
True You Weight Loss
Cary, North Carolina 27513
United StatesActive - Recruiting
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