Clinical Trial: The EVICEL® Neurosurgery Phase III Study
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Single-Blinded, Randomized, Controlled Study to Evaluate the Safety and Effectiveness of EVICEL® Fibrin Sealant (Human) Compared to a Hydrogel Sealant as an Adjunct to Sutured Dural Repair
Brief Summary: The objective of this study is to evaluate the safety and efficacy of EVICEL® Fibrin Sealant (Human) for use as an adjunct to sutured dural repair in cranial surgery.
Detailed Summary:
Sponsor: Ethicon, Inc.
Current Primary Outcome: The primary endpoint is the proportion of subjects that do not have a CSF leak during surgery and up to the 30-day post-operative period. [ Time Frame: 30 days ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Incidence of Intra-operative CSF leakage following final Valsalva maneuver [ Time Frame: Intraoperative ]
- Incidence of post-operative CSF leakage within 30 days post-operatively. [ Time Frame: 30 days ]
- Incidence of post-operative CSF leakage within 60 days post-operatively. [ Time Frame: 60 days ]
- Incidence of adverse events [ Time Frame: 60 days ]
- Incidence of surgical site infections within 30 days post-operatively [ Time Frame: 30 days ]
Original Secondary Outcome: Same as current
Information By: Ethicon, Inc.
Dates:
Date Received: May 27, 2015
Date Started: July 1, 2015
Date Completion: December 31, 2017
Last Updated: May 2, 2017
Last Verified: May 2017
