NCT00948025

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

A Multicenter, Prospective, Randomized, Comparative Study of Hollow Nerve Conduit and Avance Nerve Graft Evaluating Recovery Outcomes of Nerve Repair in the Hand. (CHANGE)

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Axogen Corporation · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The CHANGE study is a post-marketing study designed as a prospective, single-blind, randomized, two phase study comparing clinical outcomes of AVANCE Nerve Graft to hollow tube conduits. The first phase (pilot phase) assesses projected differences expected between two treatment groups. The second phase of the study provides comparison data between the two treatment groups. AVANCE Nerve Graft is current regulated in the United States as a 361 HCT/P Tissue for transplantation; not a Drug, Biologic, or Medical Device. Hollow tube conduits are currently regulated in the United States as medical devices.

Conditions

• Traumatic Nerve Injury

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2009-06-01
• Primary completion: 2014-12-01
• Completion: 2014-12-01
• First posted: 2009-07-29
• Last updated: 2020-12-01
• Results posted: 2020-12-01

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study