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

NCT04086550 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 228

Last updated 2024-06-26

No results posted yet for this study

Summary

The objective of the study is to clinically assess the safety and effectiveness of LIQOSEAL® 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 to show noninferiority compared to a control group.

Conditions

  • Cerebrospinal Fluid Leak

Interventions

DEVICE

LIQOSEAL

Adjunctive bioresorbable patch

DEVICE

DuraSeal, Adherus

synthetic absorbable sealants

Sponsors & Collaborators

  • Polyganics BV

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-20
Primary Completion
2024-02-13
Completion
2024-02-13
FDA Device
Yes

Countries

  • United States
  • Austria
  • Belgium
  • Germany
  • Italy
  • 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 NCT04086550 on ClinicalTrials.gov