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Multicenter Single-Blind RCT of CTIF Versus LNF For Treatment of GERD in Patients Requiring Hiatal Hernia Repair

NCT04795934 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2025-08-19

No results posted yet for this study

Summary

This single-blind randomized control study will follow 142 subjects across 7 sites randomized on a 1:1 ratio to compare treatment efficacy and safety between TIF and LNF in GERD patients with hiatal hernia undergoing hernia repair.

Conditions

  • GERD
  • Hiatal Hernia

Interventions

PROCEDURE

LAPAROSCOPIC PARAESOPHAGEAL HIATAL HERNIA REPAIR COMBINED WITH TRANSORAL INCISIONLESS FUNDOPLICATION

LAPAROSCOPIC PARAESOPHAGEAL HIATAL HERNIA REPAIR COMBINED WITH TRANSORAL INCISIONLESS FUNDOPLICATION VERSUS LAPAROSCOPIC NISSEN FUNDOPLICATION

Sponsors & Collaborators

  • EndoGastric Solutions

    collaborator INDUSTRY

  • University of California, Irvine

    collaborator OTHER

  • Fox Valley Surgical Associates

    collaborator UNKNOWN

  • University of Southern California

    collaborator OTHER

  • The University of Texas Health Science Center, Houston

    collaborator OTHER

  • University of Texas at Austin

    collaborator OTHER

  • Institute of Esophageal and Reflux Surgery

    collaborator UNKNOWN

  • Mayo Clinic

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-26
Primary Completion
2025-07-31
Completion
2030-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04795934 on ClinicalTrials.gov