CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 65 enrolled
Drug / intervention
Matristem +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03058731
NCT03058731N/ACompleted
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Comparison of Symptomatic and Radiographic Outcomes of Paraesophageal Hernia Repair With and Without MatriStem Surgical Matrix

University of South Florida·observational·Posted Feb 23, 2017·Updated Mar 28, 2019

In Brief

An observational study evaluating Matristem and Control for Paraesophageal Hernia. Completed, enrolled 65 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsParaesophageal Hernia
CountriesUnited States
CollaboratorsIntegra LifeSciences Corporation

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedFeb 23, 2017
Enrollment StartFeb 2, 2016
Primary CompletionApr 1, 2018
Study CompletionJan 28, 2019
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 9.4 years ago

Interventions

Matristemdevice

Paraesophageal hernia repair with MatriStem Surgical Matrix

Controldevice

Paraesophageal hernia repair with other biologic mesh