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Performance and Safety of I-020805 in Prevention of Cerebrospinal Fluid (CSF) Leakage Following Elective Craniotomy

NCT01295619 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2016-11-28

No results posted yet for this study

Summary

This is a prospective study to evaluate the performance and safety of a new medical device used in case of cerebrospinal fluid (CSF) leakage after an elective cranial surgery.

Conditions

  • Cerebrospinal Fluid Leakage

Interventions

DEVICE

I-020805

A thin layer of I-020805 applied up to two times on the sutured dura mater

Sponsors & Collaborators

  • Kuros Biosurgery AG

    lead INDUSTRY

Principal Investigators

  • Virginia Jamieson, MD · Kuros Biosurgery

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • Germany
  • Hungary

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 NCT01295619 on ClinicalTrials.gov