Combining gastric mucosal ablation with endoscopic sleeve gastroplasty for weight loss

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to create a multi-site, prospective registry to assess the clinical outcomes of patients undergoing combined gastric mucosal ablation with endoscopic sleeve gastroplasty at True You Weight Loss. The procedure involves a unique approach to obesity treatment by targeting the gastric fundus, which produces ghrelin, a hormone linked to increased appetite. By evaluating the effectiveness of this combined technique, the study seeks to determine if it can lead to better weight loss outcomes compared to traditional methods. Participants will be monitored for their weight loss progress and related health metrics over time.

Why it matters

Who can join: the full rules

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

Where it's running

• True You Weight Loss
  Atlanta, Georgia, United States Recruiting
• True You Weight Loss
  Cary, North Carolina, United States Recruiting

Study contacts

• Study coordinator: Chase Wooley, BS
• Email: Chase@trueyouweightloss.com
• Phone: (919) 336-4171

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.