A Multi-site, Prospective Registry of Patients Undergoing Combined Gastric Mucosal Ablation With Endoscopic Sleeve Gastroplasty at True You Weight Loss
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure
Study Type: Observational
SUMMARY
The purpose of this study is to construct a multi-site, prospective registry to evaluate the clinical outcomes of patients who have undergone combined gastric mucosal ablation with endoscopic sleeve gastroplasty at True You Weight Loss.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:
• Age ≥ 18 years and ≤ 65 years old
• BMI ≥ 28 and ≤55 kg/m²
• Willingness to comply with the substantial lifelong dietary restrictions required by the 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 mucosal ablation with ESG procedure at True You Weight Loss regardless of the research
Locations
United States
Georgia
True You Weight Loss
RECRUITING
Atlanta
North Carolina
True You Weight Loss
RECRUITING
Cary
Contact Information
Primary
Chase Wooley, BS
Chase@trueyouweightloss.com
(919) 336-4171
Backup
Shannon Casey, BS, MS
Shannon@trueyouweightloss.com
(919) 391-7843
Time Frame
Start Date: 2024-01-31
Estimated Completion Date: 2028-01-31
Participants
Target number of participants: 100
Treatments
Combined gastric mucosal ablation with endoscopic sleeve gastroplasty
All patients included in the multi-site, prospective registry will undergo the combined gastric mucosal ablation with endoscopic sleeve gastroplasty procedure, regardless of their participation in the research study.
Related Therapeutic Areas
Sponsors
Leads: True You Weight Loss