Actively Recruiting
Efficacy Of Hiatal Closure For Gastro-Esophageal Reflux Disease (GERD)
Led by University of Chicago · Updated on 2026-02-02
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Gastro-Esophageal Reflux Disease (GERD) affects millions of Americans, many of whom rely on long-term medication to manage symptoms. This research evaluates the effectiveness of hiatal closure surgery for early GERD, aiming to restore the function of the lower esophageal sphincter without the need for more extensive procedures like fundoplication. The study seeks to provide new insights using minimally invasive techniques to treat patients with small hiatal defects and symptomatic GERD. The study focuses on patients undergoing hiatal closure alone, a surgical approach that repairs the hiatal defect and aims to improve sphincter function. This method is being assessed using minimally invasive laparoscopic surgery. The research team will analyze outcomes to determine how well this treatment controls GERD symptoms and restores function, with procedures performed on suitable surgical candidates. Participants will have their pH levels tested at one and two years after surgery to measure treatment effectiveness. The study will monitor these patient-centered outcomes carefully over time to evaluate the recovery of esophageal function. The trial involves adult participants aged 18 to 50 who meet specific health criteria, and it is sponsored by the University of Chicago, with an estimated completion date in October 2028.
CONDITIONS
Brief Title
Efficacy Of Hiatal Closure For GERD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 - 50 years
- Able to provide informed consent
- BMI <30
- Hiatal defect <4cm on esophagram
- pH testing requirement: pH <4 for >5.5%
- Surgical candidate for hiatal closure only
You will not qualify if you...
- Vulnerable subjects including children, prisoners, and pregnant women will be excluded.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 week or until discharge
Participants undergo minimally invasive hiatal closure surgery to treat GERD and receive immediate post-operative care.
1 surgical visit and hospital stay
Duration - Up to 2 years
Participants are monitored to assess recovery and the effectiveness of the hiatal closure surgery.
Visits at 1 year and 2 years post-surgery for pH testing assessments
Trial Site Locations
Total: 1 location
1
The University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
Research Team
Y
Yalini Vigneswaran, MD
J
John Alverdy, MD
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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