Recruiting

Hiatal Closure

Sponsor:

University of Chicago

Code:

NCT06280664

Conditions

Gastro Esophageal Reflux

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Not accepted

Study Details

Brief 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.

Conditions

Gastro Esophageal Reflux

Study ID

NCT06280664

Start date

Oct 2, 2020

Status verified date

Jan, 2026

Completion date

Oct, 2028

Anticipated

Primary completion date

Oct, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 50

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Concentration of pH testing [ Time Frame: at 1 and 2 years ]

Central Contacts and Locations

Central contacts

Yalini Vigneswaran, MD

773-702-6337yvigneswaran@bsd.uchicago.edu

John Alverdy, MD

jalverdy@bsd.uchicago.edu

Locations

The University of Chicago

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Carlisa Dixon

773-834-4337cdixon520@bsd.uchicago.edu

Leila Yazdanbakhsh

773-834-5087leila.yazdanbakhsh@bsd.uchicago.edu

More Information

Sponsor

University of Chicago

Last update posted

Feb 2, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Chicago on 2026-02-02.