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Evaluate the Safety and Performance of Dura Sealant Patch in Reducing CSF Leakage Following Elective Cranial Surgery

NCT03566602 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2020-09-16

No results posted yet for this study

Summary

The objective of the study is to clinically assess the safety and performance of the Dura Sealant Patch as a means of reducing intra- as well as post-operative CSF leakage in patients undergoing elective cranial intradural surgery with a dural closure procedure.

Conditions

  • Cerebrospinal Fluid Leak

Interventions

DEVICE

Dura Sealant Patch

Adjunctive bioresorbable patch

Sponsors & Collaborators

  • Polyganics BV

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-11
Primary Completion
2019-08-31
Completion
2020-08-26

Countries

  • Netherlands
  • Switzerland

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 NCT03566602 on ClinicalTrials.gov