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NCT00444067 · ClinicalTrials.gov registry record · NA

Study to Evaluate Safety & Effectiveness of Spinal Sealant

A NA study of Cerebrospinal Fluid Leakage, Subdural, sponsored by Integra LifeSciences Corporation.

Completed
Registry status
NA
Development phase
98
Enrollment target
1
Study location

NCT00444067: Completed NA study of Cerebrospinal Fluid Leakage, Subdural, sponsored by Integra LifeSciences Corporation.

NCT00444067 is a NA study of Cerebrospinal Fluid Leakage, Subdural that has completed, run by Integra LifeSciences Corporation. The registered enrollment target is 98 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00444067, a NA study of Cerebrospinal Fluid Leakage, Subdural, has completed, sponsored by Integra LifeSciences Corporation.

COMPLETED
Registry status
NA
Development phase
98 participants
Enrollment target
1
Study location

Study Summary

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

Primary Outcome

Percent(%) success in obtaining a watertight closure following assigned treatment (Spinal Sealant or Control) where success is defined as: A watertight closure of the dural repair intraoperatively after study treatment, confirmed by Valsalva maneuver at 20-25 cm H2O for 5-10 seconds.

Interventions

  • OTHER Standard of Care
  • DEVICE Spinal Sealant

Study Locations (1)

Massachusetts

  • Confluent Surgical, Inc. - Bedford

Trial Details

FieldValue
Enrollment Target 98 participants
Start Date 2007-05
Est. Completion 2009-08
Phase NA
Integra LifeSciences Corporation

60 total trials

What the finished NCT00444067 record still lists

NCT00444067 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 98 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).

The record links to 1 condition, with Cerebrospinal Fluid Leakage, Subdural appearing as the primary indexed condition, and to 2 interventions - of which Standard of Care is the first listed.

NCT00444067 reports a single indexed study location in Massachusetts.

Frequently Asked Questions

What is clinical trial NCT00444067 about?

NCT00444067 is a clinical study titled "Study to Evaluate Safety & Effectiveness of Spinal Sealant". To evaluate a spinal sealant as an adjunct to sutured dural repair compared to standard of care techniques.

What is the current status of trial NCT00444067?

This trial is currently completed. It is a NA study. The enrollment target is 98 participants. The study started on 2007-05. Estimated completion is 2009-08.

What conditions does trial NCT00444067 study?

This clinical trial studies the following conditions: Cerebrospinal Fluid Leakage, Subdural.

What interventions are being tested in trial NCT00444067?

The interventions under investigation include: Standard of Care (OTHER), Spinal Sealant (DEVICE).

Who is sponsoring clinical trial NCT00444067?

This trial is sponsored by Integra LifeSciences Corporation, which has 60 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00444067 being conducted?

This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT00444067's enrollment target sits among peer trials

98 922nd of 2000 higher than 1,078 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00444067, the US trial registry maintained by the National Library of Medicine. NCT00444067 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.