NCT01295619

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

A Prospective, Open, Multi-center, Single-arm Study of the Performance and Safety of I-020805 in the Prevention of Cerebrospinal Fluid Leakage Following Elective Cranial Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Kuros Biosurgery AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Patients who consented to participate in the trial and fulfilled the preoperative inclusion and exclusion criteria underwent screening prior to surgical treatment. After dural suturing, if patients met the intra operative inclusion and exclusion criteria, they received I-020805. If necessary, autologous grafts were to be used to augment dural closure. I-020805 was delivered from a double syringe applicator that creates a fine layer over the dura. This layer quickly sets within seconds to form a watertight seal.

Conditions

• Cerebrospinal Fluid Leakage

Interventions

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

Timeline

• Start date: 2011-02-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2011-02-14
• Last updated: 2016-11-28

Locations

4 sites across 2 countries: Germany, Hungary