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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: 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 S

Brief 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 Summary:

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.


Sponsor: Kuros Biosurgery AG

Current Primary Outcome: Performance of I-020805 in prevention of CSF leakage [ Time Frame: Intraoperative on the day of sugery ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Incidence of CSF leakage [ Time Frame: Within 7 days after surgery or prior to discharge ]
  • CSF leakage or pseudomeningocele related surgical intervention [ Time Frame: Within 90 days following surgery ]
  • CSF leakage confirmed by clinical evaluation or diagnostic testing [ Time Frame: Within 90 days following surgery ]
  • Surgical infection and unexpected neurological signs [ Time Frame: Post-operative and within 7 days and 90 following surgery ]
  • Wound healing impairment [ Time Frame: Throughout study up to 90 days following surgery ]
  • Incidence of all and treatment emergent adverse events [ Time Frame: Throughout study up to 90 days following surgery ]


Original Secondary Outcome: Same as current

Information By: Kuros Biosurgery AG

Dates:
Date Received: February 9, 2011
Date Started: February 2011
Date Completion:
Last Updated: November 25, 2016
Last Verified: November 2016