Ablation Registry (Combined Gastric Mucosal Ablation With Endoscopic Sleeve Gastroplasty for Weight Loss)
Launched by TRUE YOU WEIGHT LOSS · May 17, 2024
Trial Information
Current as of July 21, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial, called the Ablation Registry, is looking at how well a specific weight loss procedure works for people with obesity. The procedure combines two methods: gastric mucosal ablation, which helps reduce the stomach's ability to absorb food, and endoscopic sleeve gastroplasty (ESG), which makes the stomach smaller. The goal is to gather information from several sites to understand how these treatments help patients at True You Weight Loss.
To take part in this study, you need to be between 18 and 65 years old, have a body mass index (BMI) between 28 and 55, and be willing to follow strict dietary guidelines after the procedure. You also need to be able to give your consent and, if you're a woman who can become pregnant, agree to use birth control. Participants will have the chance to receive the combined treatment and will be closely monitored for their health outcomes. However, certain conditions like current pregnancy, eating disorders, or specific psychological issues might prevent someone from joining the trial.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • 1. Age ≥ 18 years and ≤ 65 years old
- • 2. BMI ≥ 28 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 mucosal ablation with ESG 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. Patients currently taking weight-loss medications or other therapies for weight loss within the prior 6 months.
- • 5. Eating disorders including night eating syndrome (NES), bulimia, binge eating disorder, or compulsive overeating.
- • 6. At the discretion of the PI for subject safety
About True You Weight Loss
True You Weight Loss is a pioneering clinical trial sponsor dedicated to advancing innovative solutions in weight management. With a focus on evidence-based approaches, True You conducts rigorous research to evaluate the efficacy and safety of novel weight loss interventions. By collaborating with healthcare professionals and leveraging cutting-edge technology, the organization aims to empower individuals in their weight loss journeys, ultimately contributing to improved health outcomes and enhanced quality of life. True You is committed to fostering a supportive community and promoting sustainable lifestyle changes through scientifically validated programs.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Cary, North Carolina, United States
Atlanta, Georgia, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported