Observational Study of Hiatal Closure for GERD

This observational study is looking at how well hiatal closure surgery works for people with early Gastroesophageal Reflux Disease (GERD). GERD is a condition where stomach acid flows back into the esophagus, causing symptoms like heartburn. Researchers believe that closing the hiatal defect (a small opening in the diaphragm) can be an effective treatment. They will measure the concentration of acid in the esophagus using pH testing at 1 and 2 years after surgery to see how successful the treatment is. You might be able to join if you are between 18 and 50 years old, have a specific hiatal defect size, and meet certain pH testing requirements, making you a candidate for hiatal closure surgery. The study aims to enroll 40 participants, but its current recruitment status is unclear.

Study design
This is an observational study with a planned enrollment of 40 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 2 years, with pH testing measured at 1 and 2 years.

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NCT06280664

Efficacy Of Hiatal Closure For GERD

Recruiting
Not specifiedAges 18–50Observational
University of Chicago
~40 participants
Updated 2026-02-02 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Concentration of pH testing
Measured over at 1 and 2 years
Gastro Esophageal Reflux
1 sites across 1 states
Illinois1
  • Yalini Vigneswaran, MD · PRINCIPAL_INVESTIGATOR · University of Chicago

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Eligibility criteria

Inclusion

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

Vulnerable subjects (children, prisoners, pregnant women) will be excluded.
  • Concentration of pH testingat 1 and 2 years

    Determine GERD remission for hiatal closure alone for patients with pH proven GERD