DuraSeal Sealant Post Market Study

Completed · Not applicable

Conditions studied: Elective Cranial Procedures With Dural Incision

In brief

DuraSeal Dural Sealant has been approved as a dural sealant by the FDA for use in cranial and spinal procedures. This study was completed to further evaluate the safety of the DuraSeal Sealant in a post-approval setting as compared to control (defined as methods typically employed by surgeons to seal the dura).

Key facts

Study ID

NCT00704340

Run by

Integra LifeSciences Corporation

People needed

237

Starts

2005-09-01

Expected to finish

2009-05-01

Last updated by the study team

2017-09-07

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• Confluent Surgical — Waltham, Massachusetts, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.