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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-01

Study Completion Date

2028-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

ABLATE WEIGHT 2 (Single-Stage Fundic Ablation Plus ESG for Weight Loss)

NCT05992103

Obesity

ACTIVE_NOT_RECRUITING NA

ABLATE WEIGHT (Ablation Plus ESG for Weight Loss)

NCT05578703

Obesity

ACTIVE_NOT_RECRUITING NA

Endoscopic Gastric Mucosal Ablation as a Primary Obesity Therapy

NCT05486338

Obesity Adiposity

ACTIVE_NOT_RECRUITING NA

Benefits of Endoscopic Bariatric Procedures

NCT05514288

Obesity

RECRUITING NA

Endoscopic Bariatric Therapies (EBTs): A Retrospective and Prospective Multicenter Registry

NCT04494048

Obesity Weight Loss Gastro Esophageal Reflux +1 more

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Obesity is a chronic, progressive, multifactorial disease that contributes to increasing morbidity, mortality, and economic costs worldwide. The oxyntic mucosa of the gastric fundus is the principal site for the production of the orexigenic peptide hormone ghrelin. Ghrelin activates hunger-promoting pathways of the hypothalamus and opposes the satiety-promoting actions of other gastrointestinal peptides, leading to calorie-ingesting behaviors and weight gain. A method to reduce ghrelin production and decrease fundal compliance and capacity through mucosal devitalization may confer benefit to patients seeking treatment for obesity. This is a multi-site, prospective registry of patients who have elected to undergo Gastric Fundus Mucosal Ablation (GFMA) at a True You Weight Loss site in Cary, NC or Atlanta, GA. Study participants will consist of up to 200 adult patients of ages 18 to 65 years old who have elected to undergo GFMA at a True You Weight Loss site (Cary, NC or Atlanta, GA) prior to their involvement in the study. Participants that meet the criteria below will be deemed eligible for participation after consultation with the study investigator. Study participants will receive follow-up care according to standard of care practices, regardless of their involvement in the research study. Standard of care nutritional practice includes a comprehensive lifestyle program with long-term nutritional support and monitoring. Patient weights and adverse events will be collected at each visit. Adverse events will be communicated to medical team members in between dedicated visits. We aim to establish a multi-site, prospective registry to longitudinally describe GMFA in adults with obesity, including patient characteristics, weight loss, improvement in weight-related medical conditions, and adverse events.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion 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

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. 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No