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Performance Study of an Artificial Nerve Guide (Reaxon® Nerve Guide) to Treat Digital Nerve Lesions

NCT02459015 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2018-06-18

No results posted yet for this study

Summary

The purpose of this clinical investigation is to confirm the medium- and long-term safety and performance of the chitosan-based nerve guide (Reaxon® Nerve Guide) in comparison to an autologous nerve graft to bridge nerve defects in the finger.

Conditions

  • Peripheral Nerve Injuries

Interventions

DEVICE

Implantation

A peripheral nerve defect up to 26 mm in the finger will be repaired by implantation of either a Reaxon® Nerve Guide or an autologous nerve graft (depending on the randomization group) on day 0.

Sponsors & Collaborators

  • Medovent GmbH

    lead INDUSTRY

Principal Investigators

  • Frank Siemers, PD Dr. med. · BG-Kliniken Bergmannstrost

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2018-05-31
Completion
2018-05-31

Countries

  • Germany

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 NCT02459015 on ClinicalTrials.gov