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Study to Evaluate Safety & Effectiveness of Spinal Sealant

NCT00444067 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2017-09-07

Study results available
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Summary

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

Conditions

  • Cerebrospinal Fluid Leakage, Subdural

Interventions

DEVICE

Spinal Sealant

Spinal Sealant System

OTHER

Standard of Care

Standard of Care

Sponsors & Collaborators

  • Medtronic - MITG

    collaborator INDUSTRY

  • Integra LifeSciences Corporation

    lead INDUSTRY

Principal Investigators

  • Jen Doyle · Conlfuent Surgical/Covidien

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2009-08-31
Completion
2009-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00444067 on ClinicalTrials.gov