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Use of Spinal Sealant System During Spinal Surgery

NCT00458354 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2011-10-12

No results posted yet for this study

Summary

1. To evaluate the safety and efficacy of the Spinal Sealant as an adjunct to sutured dural repair compared with standard of care methods (control) to obtain watertight dural closure intraoperatively in patients undergoing spinal surgery.
2. To evaluate the safety and efficacy of the Spinal Sealant as an adjunct to sutured dural repair compared with standard of care methods (control) to obtain watertight dural closure in patients undergoing spinal surgery up to 90 days post-procedure.

Conditions

  • Spine Surgery
  • Excessive Repair
  • Spinal Cord Injuries
  • Complication of Surgical Procedure

Interventions

DEVICE

Spinal Sealant

Spinal Sealant System which will be sprayed over the stitches to close the opening in the dura.

PROCEDURE

Standard Methods of Closing of the Dura

Standard methods such as the closing of the dura with stitches.

Sponsors & Collaborators

  • Confluent Surgical

    collaborator INDUSTRY

  • M.D. Anderson Cancer Center

    lead OTHER

Principal Investigators

  • Ian E. McCutcheon, MD · M.D. Anderson Cancer Center

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
2006-01-31
Primary Completion
2007-11-30
Completion
2008-12-31

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 NCT00458354 on ClinicalTrials.gov