DuraSeal Sealant Post Market Study

This study is currently recruiting participants.

Verified by Confluent Surgical, June 2008

First Received: June 23, 2008 No Changes Posted

Sponsors and Collaborators:	Confluent Surgical Covidien
Information provided by:	Confluent Surgical
ClinicalTrials.gov Identifier:	NCT00704340

Purpose

Study to further characterize the use of the DuraSeal Sealant in a post-PMA approval setting as compared to "standard of care".

Condition	Intervention	Phase
Elective Cranial Procedures With Dural Incision	Device: DuraSeal Dural Sealant System Other: Standard of Care	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment
Official Title:	DuraSeal Sealant Post Market Study

Further study details as provided by Confluent Surgical:

Primary Outcome Measures:

Incidence of neurosurgical complications related to unplanned intervention or return to the operating room. [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	250
Study Start Date:	September 2005
Estimated Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1 DuraSeal Dural Sealant System - FDA Approved Device	Device: DuraSeal Dural Sealant System The DuraSeal™ Dural Sealant System is intended for use as an adjunct to sutured dural repair during cranial surgery to provide watertight closure. DuraSeal should only be used with autologous duraplasty material.
2: Active Comparator Standard of Care (control)	Other: Standard of Care Standard procedure to obtain intraoperative watertight dural closure

Eligibility

Criteria

Inclusion Criteria:

Patient is between 18 and 75 years of age
Patient is scheduled for an elective cranial procedure that entails a dural incision
Evidence of intraoperative non-watertight closure

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00704340

Contacts

Contact: Jennifer L Doyle

781-839-1770

Locations

United States, Massachusetts
Confluent Surgical	Recruiting
Waltham, Massachusetts, United States, 02451
Contact: Jennifer Doyle 781-839-1770

Sponsors and Collaborators

Confluent Surgical

Covidien

More Information

No publications provided

Responsible Party:	Covidien ( Jennifer Doyle - Director, Clinical Affairs )
Study ID Numbers:	DRS-05-002
Study First Received:	June 23, 2008
Last Updated:	June 23, 2008
ClinicalTrials.gov Identifier:	NCT00704340 History of Changes
Health Authority:	United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 06, 2009