Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT06444347

Impact of Biosynthetic Mesh on Paraesophageal Hernia Repair

Led by Weill Medical College of Cornell University · Updated on 2025-11-18

200

Participants Needed

6

Research Sites

316 weeks

Total Duration

On this page

Sponsors

W

Weill Medical College of Cornell University

Lead Sponsor

I

Intuitive Surgical

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Impact of Biosynthetic Mesh on Paraesophageal Hernia Repair

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Documented diagnosis of gastroesophageal reflux disease
  • Adults aged 18 years or older
  • English speaking
  • Subject is planned to undergo surgery for reflux disease
Not Eligible

You will not qualify if you...

  • Physician deems the subject is unable to complete the study due to documented dementia
  • Subject is undergoing emergent surgery
  • Pregnancy
  • Patient has known allergy to tetracycline hydrochloride or kanamycin sulfate

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 6 locations

1

University of Southern California Keck School of Medicine

Los Angeles, California, United States, 90089

Withdrawn

2

Louisiana State University School of Medicine

New Orleans, Louisiana, United States, 70112

Withdrawn

3

Washington University School of Medicine

St Louis, Missouri, United States, 63110

Withdrawn

4

NYU Langone Health

New York, New York, United States, 10016

Not Yet Recruiting

5

Weill Cornell Medicine

New York, New York, United States, 10065

Actively Recruiting

6

Lenox Hill Hospital

New York, New York, United States, 10075

Not Yet Recruiting

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Research Team

A

Annabel Endean, NP

CONTACT

N

Niloufar Salehi, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Impact of Biosynthetic Mesh on Paraesophageal Hernia Repair | DecenTrialz