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ACELL Mesh for Paraesophageal Hernia Repair

NCT03058731 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 65

Last updated 2019-03-28

No results posted yet for this study

Summary

This is a prospective, case-matched, systematic follow up of up to 70 pre-existing patients whom underwent paraesophageal hernia repair between June 1, 2012 and September 30, 2016. Patients whom are willing to participate in the study will be asked to return for a one time follow up visit to reassess for hiatal hernia recurrence both symptomatically and radiologically to compare the efficacy of the use of MatriStem Surgical Matrix (ACell) mesh to other biologic meshes.

Conditions

  • Paraesophageal Hernia

Interventions

DEVICE

Matristem

Paraesophageal hernia repair with MatriStem Surgical Matrix

DEVICE

Control

Paraesophageal hernia repair with other biologic mesh

Sponsors & Collaborators

  • Integra LifeSciences Corporation

    collaborator INDUSTRY

  • University of South Florida

    lead OTHER

Principal Investigators

  • Vic Velanovich, MD · University of South Florida

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-02
Primary Completion
2018-04-01
Completion
2019-01-28
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 NCT03058731 on ClinicalTrials.gov