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A Comparative Post-marketing Study of Commercially Available Peripheral Nerve Gap Repair Options

NCT00948025 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2020-12-01

Study results available
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Summary

This study is a comparison of sensory recovery outcomes following the use of AVANCE Nerve Graft or hollow tube conduit for peripheral nerve gap repairs in the hand.

Conditions

  • Traumatic Nerve Injury

Interventions

DEVICE

Hollow tube nerve conduit, synthetic or biosynthetic

Appropriately size matched hollow tube nerve conduit (Neurotube, NeuroLac, NeuraGen, NeuroMatrix, NeuroFlex)

OTHER

Processed Human Nerve Tissue

Implantation of appropriate length of processed human nerve tissue at time of surgery.

Sponsors & Collaborators

  • Axogen Corporation

    lead INDUSTRY

Principal Investigators

  • Erick W DeVinney · Axogen Corporation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2014-12-31
Completion
2014-12-31
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 NCT00948025 on ClinicalTrials.gov