Evaluating hiatal closure for treating early GERD
Official title: Efficacy Of Hiatal Closure For GERD
Run by University of Chicago · NCT06280664 · Data updated 2026-11-12
This study is testing if a new surgical method called hiatal closure can help people with early GERD feel better by fixing the problem with their esophagus.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 50 Years |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | University of Chicago Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Status | Recruiting |
| Started | October 2, 2020 |
| Main results expected | October 2028 |
| Study ends | October 2028 |
| Registry record updated | February 2, 2026 |
| Trial ID | NCT06280664 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 to 50 with a BMI under 30 and specific pH testing results indicating GERD.
✕Probably not a fit
Patients who are outside the age range, have a higher BMI, or have more severe GERD symptoms may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to assess the effectiveness of hiatal closure as a treatment for early Gastro-Esophageal Reflux Disease (GERD). The researchers hypothesize that this surgical approach can effectively address the underlying causes of GERD by repairing the anatomical defect and restoring the function of the lower esophageal sphincter. With the rise of minimally invasive laparoscopic techniques, the study seeks to explore the outcomes of hiatal closure alone, as opposed to traditional methods that often include fundoplication. The study will involve patients who meet specific eligibility criteria, focusing on those who are surgical candidates for hiatal closure.
Why it matters
Potential benefit: If successful, this approach could provide a less invasive and effective treatment option for patients suffering from early GERD.
How similar studies have gone: While traditional approaches to GERD treatment have been well-studied, the specific focus on hiatal closure alone is less explored, making this a novel investigation.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Vulnerable subjects (children, prisoners, pregnant women) will be excluded.
Where it's running
-
The University of Chicago
Chicago, Illinois, United States Recruiting
Study contacts
- Principal investigator: Yalini Vigneswaran, MD — University of Chicago
- Study coordinator: Yalini Vigneswaran, MD
- Email: yvigneswaran@bsd.uchicago.edu
- Phone: 773-702-6337
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.