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The Efficacy and Safety of Lyoplant® Onlay in Repairing Cerebral Dura Mater

NCT03951272 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2019-05-15

No results posted yet for this study

Summary

Objective of this clinical trial is to compare the safety and efficacy of Mianfengxing Kexishou Yingmo Bupian(Lyoplant® Onlay) and Yingmo Bupianfor dural repair.270 subjects will be enrolled for this study.

Conditions

  • Replacement and Extension of Connective Tissue Structure in Neurosurgery

Interventions

DEVICE

Lyoplant® Onlay/DURAFORM™ Dural Graft Implant

Lyoplant® Onlay will be used as a dura substitute for the repair of the duramater.The DURAFORM™ Dural Graft Implant will be used in the procedures where the repair or substitution of the patient's dura mater is needed.

Sponsors & Collaborators

  • B. Braun Medical International Trading Company Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-07-24
Primary Completion
2019-08-30
Completion
2019-08-30

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 NCT03951272 on ClinicalTrials.gov