Ablation Registry (Combined Gastric Mucosal Ablation With Endoscopic Sleeve Gastroplasty for Weight Loss)

Description

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

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Study Overview

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Study Details

Study overview

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.

A Multi-site, Prospective Registry of Patients Undergoing Combined Gastric Mucosal Ablation With Endoscopic Sleeve Gastroplasty at True You Weight Loss

Ablation Registry (Combined Gastric Mucosal Ablation With Endoscopic Sleeve Gastroplasty for Weight Loss)

Condition
Obesity
Intervention / Treatment

-

Contacts and Locations

Atlanta

True You Weight Loss, Atlanta, Georgia, United States, 30342

Cary

True You Weight Loss, Cary, North Carolina, United States, 27513

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

True You Weight Loss,

Study Record Dates

2028-01-31