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Gastro Esophageal RefluxNCT06280664

Efficacy Of Hiatal Closure For GERD

An observational study of Gastro Esophageal Reflux, run by University of Chicago at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose of this protocol is to study the efficacy of hiatal closure for early GERD disease. The study team hypothesizes that hiatal closure for early GERD disease is an efficacious treatment of GERD. Read more about this study

Who is it for?
Ages 18 to 50 years
Conditions the study is for
Gastro Esophageal Reflux
How many people
40 participants
Where
1 siteUnited States
Study dates
2 Oct 2020to Oct 2028
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • All sexes
  • No healthy volunteers
  • Adult

Study population: The estimated annual number of subjects enrolled prospectively in the study is 20. The recruitment goal is 40. The research team will screen all patients that are being followed-up at the gastrointestinal surgery clinic at the UCM.

Who may be able to join

  • 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

Who cannot join

  • Vulnerable subjects (children, prisoners, pregnant women) will be excluded.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yalini Vigneswaran, MD contact

773-702-6337

yvigneswaran@bsd.uchicago.edu

John Alverdy, MD contact

jalverdy@bsd.uchicago.edu

United States1 site, 1 recruiting
  • The University of Chicago

    Chicago, Illinois, 60637

    Carlisa Dixon, 773-834-4337, cdixon520@bsd.uchicago.edu

    Leila Yazdanbakhsh, 773-834-5087, leila.yazdanbakhsh@bsd.uchicago.edu

    Recruiting

Other trials in United States

About this study

The purpose of this protocol is to study the efficacy of hiatal closure for early GERD disease. The study team hypothesizes that hiatal closure for early GERD disease is an efficacious treatment of GERD.

Read the detailed description

Gastro-Esophageal Reflux Disease (GERD) affects 60 million Americans involving an estimated 20 million Americans dependent on long term medication to control symptoms and progression of the disease. Although surgical hiatal hernia repair and creation of an anti-reflux valve can correct the underlying cause of GERD by repairing the anatomic defect and reestablishing the competency of the lower esophageal sphincter (LES), only 24,000 patients annually undergo surgery for GERD. However, with the advent of minimally invasive laparoscopic techniques to treat GERD, more patients at early phases of the disorder are being surgically treated.

The traditional approach to surgical treatment of GERD has been hiatal hernia repair with Nissen fundoplication. However, fundoplication itself may be unnecessary for recovery of the lower esophageal sphincter. Several groups have demonstrated that partial or even minimal wrapping of the esophagus achieves equal control of GERD to complete wrapping. Despite extensive geometric and physics-based explanations for this observational enigma, the science underlying these highly reproducible observations across surgeons and continents remains poorly understood. Furthermore, outcomes following hiatal hernia repair alone for the treatment of GERD have not been studied since before the advances in laparoscopic technique.

Because of the high-volume gastrointestinal surgery center, the study team has the opportunity to rigorously study patient-centered outcomes and the disease processes as they are treated with this surgery. These outcomes after hiatal closure alone have not been published with the use of minimally invasive techniques where rigorous repairs can be achieved and thus, the study team is seeking this opportunity to demonstrate the efficacy of hiatal closure alone and recovery of the lower esophageal sphincter in those patients with symptomatic GERD and small hiatal defects. Publishing outcomes of this technique would represent a great leap forward in enhancing the knowledge base upon which to define the principles and techniques for the surgical treatment of GERD.

Medical subject headings
Gastroesophageal Reflux

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Concentration of pH testing

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

    Measured: at 1 and 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2024
  2. Study start2 Oct 2020
  3. Primary completionOct 2028 (estimated)
  4. Study completionOct 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06280664
Sponsor's protocol ID
IRB20-1151
Status last verified
Jan 2026
First submitted
19 Feb 2024
Last updated
2 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Gastro Esophageal Reflux, run by University of Chicago at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yalini Vigneswaran, MD (773-702-6337, yvigneswaran@bsd.uchicago.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Concentration of pH testing (time frame: at 1 and 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.

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