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Impact of Biosynthetic Mesh on Paraesophageal Hernia Repair

NCT06444347 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-11-18

No results posted yet for this study

Summary

The aim of this study is to find out if using a certain kind of mesh can reduce the chances of hiatal hernias coming back after anti-reflux surgery. Participants undergoing antireflux surgery will be assigned to one of two groups, a group that has surgery with mesh, or a group that has surgery without mesh.

Conditions

  • Hiatal Hernia

Interventions

PROCEDURE

Hiatal Hernia Repair

The non-mesh group will undergo hiatal hernia repair with permanent suture only.

DEVICE

Biosynthetic Mesh

The biosynthetic mesh group will undergo hiatal hernia repair with Phasix Mesh (Becton Dickinson, Franklin Lakes, NJ) reinforcement, secured with permanent suture.

Sponsors & Collaborators

  • Intuitive Surgical

    collaborator INDUSTRY

  • Weill Medical College of Cornell University

    lead OTHER

Principal Investigators

  • Rasa Zarnegar, MD · Weill Medical College of Cornell University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-10
Primary Completion
2026-07-31
Completion
2030-07-31
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT06444347 on ClinicalTrials.gov