RECRUITING

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

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Conditions

Obesityghrelinfundus ablationgastric mucosal ablationendoscopic sleeve gastroplastyESG-MAXablationhungerTrue You Weight Loss

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-01-31
Study Completion:2028-01-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06420700

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.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age ≥ 18 years and ≤ 65 years old
  2. 2. BMI ≥ 28 and ≤55 kg/m²
  3. 3. Willingness to comply with the substantial lifelong dietary restrictions required by the procedure.
  4. 4. Ability to give informed consent
  5. 5. Women of childbearing potential (i.e., not post-menopausal or surgically sterilized) must agree to use adequate birth control methods.
  6. 6. Those who plan to receive the gastric mucosal ablation with ESG procedure at True You Weight Loss regardless of the research
  1. 1. Patients that do not meet eligibility requirements for the study as per the Principal Investigator's standard selection criteria
  2. 2. Active psychological issues preventing participation in a life-style modification program as determined by a psychologist.
  3. 3. Patients who are pregnant or breast-feeding.
  4. 4. Patients currently taking weight-loss medications or other therapies for weight loss within the prior 6 months.
  5. 5. Eating disorders including night eating syndrome (NES), bulimia, binge eating disorder, or compulsive overeating.
  6. 6. At the discretion of the PI for subject safety

Contacts and Locations

Study Contact

Chase Wooley, BS
CONTACT
(919) 336-4171
Chase@trueyouweightloss.com
Shannon Casey, BS, MS
CONTACT
(919) 391-7843
Shannon@trueyouweightloss.com

Study Locations (Sites)

True You Weight Loss
Atlanta, Georgia, 30342
United States
True You Weight Loss
Cary, North Carolina, 27513
United States

Collaborators and Investigators

Sponsor: True You Weight Loss

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-31
Study Completion Date2028-01-31

Study Record Updates

Study Start Date2024-01-31
Study Completion Date2028-01-31

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Obesity