NCT06280664

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
29mo left

Started Oct 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress70%
Oct 2020Oct 2028

Study Start

First participant enrolled

October 2, 2020

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

February 19, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 28, 2024

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2028

Last Updated

February 2, 2026

Status Verified

January 1, 2026

Enrollment Period

8 years

First QC Date

February 19, 2024

Last Update Submit

January 29, 2026

Conditions

Gastro Esophageal Reflux

Outcome Measures

Primary Outcomes (1)

  • Concentration of pH testing

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

    at 1 and 2 years

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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 may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Chicago

Chicago, Illinois, 60637, United States

RECRUITING

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Yalini Vigneswaran, MD

    University of Chicago

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yalini Vigneswaran, MD

CONTACT

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

John Alverdy, MD

CONTACT

jalverdy@bsd.uchicago.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 19, 2024

First Posted

February 28, 2024

Study Start

October 2, 2020

Primary Completion (Estimated)

October 1, 2028

Study Completion (Estimated)

October 1, 2028

Last Updated

February 2, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)