Actively Recruiting

Age: 18Years - 65Years
All Genders
NCT06428617

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

Led by True You Weight Loss · Updated on 2025-04-10

200

Participants Needed

1

Research Sites

208 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 65 years old
  • Body mass index (BMI) between 27 and 55 kg/m²
  • Willingness to follow lifelong dietary restrictions required by the procedure
  • Ability to give informed consent
  • Women of childbearing potential must agree to use effective birth control
  • Planning to undergo gastric fundus mucosal ablation at True You Weight Loss
Not Eligible

You will not qualify if you...

  • Do not meet eligibility requirements set by the Principal Investigator
  • Active psychological issues preventing participation in lifestyle modification
  • Currently pregnant or breastfeeding
  • Have eating disorders such as night eating syndrome, bulimia, binge eating, or compulsive overeating
  • Current or past tobacco use
  • Previous gastric surgery (e.g., sleeve gastrectomy, gastric bypass, hernia repair, fundoplication, gastric band)
  • On anticoagulant or antithrombotic therapy that cannot be stopped for 12 weeks after GFMA
  • Unable to commit to 12 weeks of ulcer prevention medication after GFMA
  • Any other safety concerns as determined by the Principal Investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

True You Weight Loss

Cary, North Carolina, United States, 27513

Actively Recruiting

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Research Team

C

Chase Wooley, BS

CONTACT

S

Shannon Casey, BS, MS

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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