Recruiting

Gastric Mucosal Ablation

Sponsor:

True You Weight Loss

Code:

NCT06420700

Conditions

Obesity

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Combined gastric mucosal ablation with endoscopic sleeve gastroplasty

Study Details

Brief 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.

Conditions

Obesity

Study ID

NCT06420700

Start date

Jan 31, 2024

Status verified date

May, 2024

Completion date

Jan 31, 2028

Anticipated

Primary completion date

Jan 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Combined gastric mucosal ablation with endoscopic sleeve gastroplasty

Combined gastric mucosal ablation with endoscopic sleeve gastroplasty in the treatment of adults with obesity

Primary outcome measure

  • Percent Change in Total Body Weight Loss (TBWL) from Baseline [ Time Frame: 12 Months ]

Central Contacts and Locations

Locations

True You Weight Loss

Recruiting

Atlanta, Georgia, United States, 30342

Principal Investigator:

Christopher McGowan, MD, MSCR

True You Weight Loss

Recruiting

Cary, North Carolina, United States, 27513

Principal Investigator:

Christopher McGowan, MD, MSCR

More Information

Sponsor

True You Weight Loss

Last update posted

May 22, 2024

Last verified

May, 2024

Keywords

  • ghrelin
  • fundus ablation
  • gastric mucosal ablation
  • endoscopic sleeve gastroplasty
  • ESG-MAX
  • obesity
  • ablation
  • hunger
  • True You Weight Loss

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by True You Weight Loss on 2024-05-22.