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

NCT06428617 | Recruiting

• 1 other identifier: RGT-002
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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 gastric fundus mucosal ablation at True You Weight Loss.

Conditions

Obesity

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Percent Change in Total Body Weight Loss (TBWL) from Baseline

  Measured percent change in total body weight over time following Gastric Fundus Mucosal Ablation. %TBWL = (pre-op weight - post op body weight) / (pre-op weight) \* 100 measured as a percentage.

  12 Months

Secondary Outcomes (3)

• Percent Change in Total Body Weight Loss (TBWL) from Baseline

  3 Months, 6 Months, 9 Months, 12 Months, 15 Months, 24 Months

• Percent Excess Weight Loss from Baseline (EWL)

  3 Months, 6 Months, 9 Months, 12 Months, 15 Months, 24 Months

• Change in Body Mass Index (BMI) from Baseline

  3 Months, 6 Months, 9 Months, 12 Months, 15 Months, 24 Months

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study participants will consist of up to 200 adult patients of ages 18 to 65 years old who have elected to undergo Gastric Fundus Mucosal Ablation (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. All eligibility criteria must be met at the time of enrollment.

You may qualify if:

• Age ≥ 18 years and ≤ 65 years old
• BMI ≥ 27 and ≤55 kg/m²
• Willingness to comply with the substantial lifelong dietary restrictions required by the procedure.
• Ability to give informed consent
• Women of childbearing potential (i.e., not post-menopausal or surgically sterilized) must agree to use adequate birth control methods.
• Those who plan to receive the gastric fundus mucosal ablation procedure at True You Weight Loss regardless of the research

You may not qualify if:

• Patients that do not meet eligibility requirements for the study as per the Principal Investigator's standard selection criteria
• Active psychological issues preventing participation in a life-style modification program as determined by a psychologist.
• Patients who are pregnant or breast-feeding.
• Eating disorders including night eating syndrome (NES), bulimia, binge eating disorder, or compulsive overeating.
• Patients with previous or current tobacco use
• Patients with prior gastric surgery (e.g., vertical sleeve gastrectomy, gastric bypass, hiatal hernia repair, Nissen fundoplication, adjustable gastric band).
• Patients on therapeutic anticoagulation or antithrombotics that cannot be interrupted for at least 12 weeks following GFMA.
• Patients who cannot commit to 12 weeks of post-GMFA pharmacologic ulcer prophylaxis
• At the discretion of the PI for subject safety

Sponsors & Collaborators

• True You Weight Loss: lead

Study Sites (1)

True You Weight Loss

Cary, North Carolina, 27513, United States

RECRUITING

Related Links

• Sponsor Website for more information

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Chase Wooley, BS

CONTACT

919-336-4171; Chase@trueyouweightloss.com

Shannon Casey, BS, MS

CONTACT

(919) 391-7843; Shannon@trueyouweightloss.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2024
• First Posted: May 24, 2024
• Study Start: June 1, 2024
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: April 10, 2025

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)