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Comparison of Processed Nerve Allograft and Collagen Nerve Cuffs for Peripheral Nerve Repair

NCT01809002 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2023-07-12

Study results available
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Summary

Processed Nerve Allograft and Collagen Nerve Cuffs will be compared to assess safety and functional outcomes for the repair of nerve injuries in the hand.

Conditions

  • Peripheral Nerve Discontinuities

Interventions

BIOLOGICAL

Processed Nerve Allograft (human)

DEVICE

Collagen Nerve Cuff

Bovine collagen based nerve cuff

Sponsors & Collaborators

  • Axogen Corporation

    lead INDUSTRY

Principal Investigators

  • Jonathan E Isaacs, MD · Virginia Commonwealth University Medical Center

  • L. Scott Levin, MD FACS · University of Pennsylvania

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2021-08-30
Completion
2021-08-30
FDA Drug
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 NCT01809002 on ClinicalTrials.gov