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

Launched by TRUE YOU WEIGHT LOSS · May 20, 2024

Keywords

ClinConnect Summary

The Fundus Ablation Registry is a clinical trial aimed at understanding how well a specific procedure called gastric fundus mucosal ablation works for people dealing with obesity. This procedure involves treating a part of the stomach to help with weight loss. The study is currently recruiting participants aged between 18 and 65 years who have a body mass index (BMI) between 27 and 55. To participate, individuals must be willing to follow a strict diet for life and be able to give their consent to join the study. Women who can become pregnant need to use birth control while participating.

If you decide to join this trial, you will receive the gastric fundus mucosal ablation at True You Weight Loss and will be monitored for your health outcomes afterward. It's important to note that certain individuals may not be eligible, such as those with specific mental health issues, eating disorders, or those who have had certain types of stomach surgeries. If you're interested, this study could provide valuable information that may help improve weight loss treatments for others in the future!

Gender

ALL

Eligibility criteria

• 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