RECRUITING

Fundus Ablation Registry (Gastric Fundus Mucosal Ablation for Weight Loss)

Conditions

Obesity ghrelin hunger ablation True You Weight Loss hunger hormone fundus fundus ablation fundic ablation GFMA

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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 gastric fundus mucosal ablation at True You Weight Loss.

Official Title

A Multi-site, Prospective Registry of Patients Undergoing Gastric Fundal Mucosal Ablation at True You Weight Loss

Quick Facts

Study Start:2024-06-01

Study Completion:2028-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06428617

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 Criteria	Exclusion Criteria
1. Age ≥ 18 years and ≤ 65 years old 2. BMI ≥ 27 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 fundus mucosal ablation 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. Eating disorders including night eating syndrome (NES), bulimia, binge eating disorder, or compulsive overeating. 5. Patients with previous or current tobacco use 6. Patients with prior gastric surgery (e.g., vertical sleeve gastrectomy, gastric bypass, hiatal hernia repair, Nissen fundoplication, adjustable gastric band). 7. Patients on therapeutic anticoagulation or antithrombotics that cannot be interrupted for at least 12 weeks following GFMA. 8. Patients who cannot commit to 12 weeks of post-GMFA pharmacologic ulcer prophylaxis 9. At the discretion of the PI for subject safety

Inclusion Criteria

Exclusion Criteria

1. Age ≥ 18 years and ≤ 65 years old
2. BMI ≥ 27 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 fundus mucosal ablation 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. Eating disorders including night eating syndrome (NES), bulimia, binge eating disorder, or compulsive overeating.
5. Patients with previous or current tobacco use
6. Patients with prior gastric surgery (e.g., vertical sleeve gastrectomy, gastric bypass, hiatal hernia repair, Nissen fundoplication, adjustable gastric band).
7. Patients on therapeutic anticoagulation or antithrombotics that cannot be interrupted for at least 12 weeks following GFMA.
8. Patients who cannot commit to 12 weeks of post-GMFA pharmacologic ulcer prophylaxis
9. 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

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 Date2024-06-01

Study Completion Date2028-06

Study Record Updates

Study Start Date2024-06-01

Study Completion Date2028-06

Terms related to this study

Keywords Provided by Researchers

obesity
ghrelin
hunger
ablation
True You Weight Loss
hunger hormone
fundus
fundus ablation
fundic ablation
GFMA

Additional Relevant MeSH Terms

Obesity