MedTrace Logo

Biologic Versus Synthetic Mesh for Treatment of Paraesophageal Hernia

NCT02242526 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 312

Last updated 2018-10-15

No results posted yet for this study

Summary

The investigators propose a randomized, single blinded controlled trial to compare the use of synthetic versus biologic mesh in hiatal hernia repair, two currently accepted standard of care surgical modalities. The investigators hypothesize that use of synthetic mesh will have lower recurrence at these time points compared to use of biologic mesh.

Conditions

  • Hiatal Hernia

Interventions

DEVICE

Parietex™ Composite Hiatal Mesh, North Haven, CT

Parietex™ Composite Hiatal Mesh (North Haven, CT) designed for hiatal hernia repair.

DEVICE

Biodesign™ Surgisis® Graft, Cook Medical, Bloomington

Biodesign™ Surgisis® Graft (Cook Medical, Bloomington) designed for hiatal hernia repair.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2019-09-30
Completion
2020-08-31

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 NCT02242526 on ClinicalTrials.gov