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NCT01410864 · ClinicalTrials.gov registry record
DuraSeal Exact Spine Sealant System Post-Approval Study
A clinical trial of Dural Sealing, sponsored by Integra LifeSciences Corporation.
- Completed
- Registry status
- 924
- Enrollment target
- 20
- Study locations
NCT01410864 is a study of Dural Sealing that has completed, run by Integra LifeSciences Corporation. The registered enrollment target is 924 participants. The trial reports 20 study locations across 13 states.
The verdict
NCT01410864, a study of Dural Sealing, has completed, sponsored by Integra LifeSciences Corporation.
- COMPLETED
- Registry status
- 924 participants
- Enrollment target
- 20
- Study locations
Study Summary
This is a non-randomized, post-approval study to further evaluate the rate of post-operative Cerebral Spinal Fluid (CSF) leaks in subjects who undergo a spinal procedure and receive DuraSeal Exact Spine Sealant System.
Conditions Studied
Interventions
- OTHER Control
- DEVICE DuraSeal Exact Spine Sealant System
Study Locations (20)
California
- - Los Angeles
- - Sacramento
- - San Francisco
- - San Jose
- - Stanford
Colorado
- - Boulder
- - Colorado Springs
- - Denver
Florida
- - Tampa
- - Tampa
Arizona
- - Phoenix
District of Columbia
- - Washington D.C.
Georgia
- - Atlanta
Illinois
- - Chicago
Kansas
- - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 924 participants |
| Start Date | 2011-08 |
| Est. Completion | 2016-07 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01410864
The ClinicalTrials.gov registry entry for NCT01410864 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 924 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Integra LifeSciences Corporation, which has 60 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Dural Sealing appearing as the primary indexed condition, and to 2 interventions - of which Control is the first listed.
NCT01410864 reports 20 study locations spanning 13 distinct geographic areas - top geographies include California, Colorado, Florida.
Frequently Asked Questions
What is clinical trial NCT01410864 about?
NCT01410864 is a clinical study titled "DuraSeal Exact Spine Sealant System Post-Approval Study". This is a non-randomized, post-approval study to further evaluate the rate of post-operative Cerebral Spinal Fluid (CSF) leaks in subjects who undergo a spinal procedure and receive DuraSeal Exact Spine Sealant System.
What is the current status of trial NCT01410864?
This trial is currently completed. The enrollment target is 924 participants. The study started on 2011-08. Estimated completion is 2016-07.
What conditions does trial NCT01410864 study?
This clinical trial studies the following conditions: Dural Sealing.
What interventions are being tested in trial NCT01410864?
The interventions under investigation include: Control (OTHER), DuraSeal Exact Spine Sealant System (DEVICE).
Who is sponsoring clinical trial NCT01410864?
This trial is sponsored by Integra LifeSciences Corporation, which has 60 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01410864 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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