CompletedNot Applicable

Study to Evaluate Safety & Effectiveness of Spinal Sealant

United States98 participantsStarted 2007-05

Plain-language summary

To evaluate a spinal sealant as an adjunct to sutured dural repair compared to standard of care techniques.

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Subjects scheduled for a spinal procedure that requires a dural incision

Percent(%) Success in Obtaining a Watertight Closure Following Assigned Treatment (Spinal Sealant or Control)

Timeframe: Intra-operative

NCT IDNCT00444067

SponsorIntegra LifeSciences Corporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2009-08

Results submitted2012-07-17