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Study to Evaluate the Safety and Efficacy of Dural Repair Patch in Neurosurgical Repairs

NCT02129114 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 132

Last updated 2014-07-08

No results posted yet for this study

Summary

1. Most of dural defects may lead to subcutaneous effusion and Cerebral Spinal Fluid (CSF) leakage, which may result in infection; besides, direct adhesion of brain tissues with sub-scalp tissues also increase the risk of epilepsy, in severe cases, dural defect is considered a life-threatening condition. So, it's important to repair the dura mater for restoring its full integrity .
2. Dural Repair Patch(ReDura Onlay) manufactured by Guangzhou Medprin Regenerative Medical Technologies Co., Ltd. As a product made of clinical absorbable polymer materials by using bionic technology, Dural Repair Patch has highly bionic 3-dimensional structure which is proved to facilitate migration and growth of regenerative cells, as well as to accelerate the growth and repairing of regenerative meninges. While the material is degraded gradually and absorbed by the body, regenerative meningeal tissue is gradually formed, achieving true reconstruction of the dura mater.
3. To evaluate the safety and effectiveness of Dural Repair Patch in neurosurgical repairs of dural defects.

Conditions

  • Neurosurgical Repairs

Interventions

DEVICE

ReDura Onlay

Subject will be clinically followed post-surgery until hospital discharge or within ten (10) days of the procedure and at three (3) months and six (6) months. The data up to and including the 6 month follow-up visit will be used in demonstrating the performance of ReDura Onlay.

DEVICE

DuraGen

Subject will be clinically followed post-surgery until hospital discharge or within ten (10) days of the procedure and at three (3) months and six (6) months. The data up to and including the 6 month follow-up visit will be used in demonstrating the performance of DuraGen.

Sponsors & Collaborators

  • Medprin Regenerative Medical Technologies Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Ke Yi Quan, professor · Southern Medical University, China

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
2014-04-30
Primary Completion
2014-12-31
Completion
2015-05-31

Countries

  • China

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 NCT02129114 on ClinicalTrials.gov