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NCT00439309 · ClinicalTrials.gov registry record · NA
Study to Evaluate Safety & Effectiveness of Vascular Sealant System
A NA study, sponsored by Integra LifeSciences Corporation.
- Terminated
- Registry status
- NA
- Development phase
- 69
- Enrollment target
NCT00439309: Clinical Trial NA study, sponsored by Integra LifeSciences Corporation.
NCT00439309 is a NA study that was terminated before completion, run by Integra LifeSciences Corporation. The registered enrollment target is 69 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00439309, a NA study, was terminated before completion, sponsored by Integra LifeSciences Corporation.
- TERMINATED
- Registry status
- NA
- Development phase
- 69 participants
- Enrollment target
Study Summary
To evaluate a new vascular sealant compared to control for the control of suture line bleeding after vascular reconstructive surgery.
Primary Outcome
The primary effectiveness endpoint is sealing success defined as complete anastomotic suture line sealing within 10 minutes following restoration of blood flow without use of an adjunctive hemostatic technique different from the assigned treatment. The primary effectiveness endpoint was evaluated on a per subject basis. For subjects with two treated sites, the subject is considered a success only if there is complete anastomotic suture line sealing within 10 minutes at both sites.
Interventions
- DEVICE Gelfoam/Thrombin
- DEVICE VascuSeal
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 69 participants |
| Start Date | 2007-04 |
| Est. Completion | 2008-05 |
| Phase | NA |
Why NCT00439309 stopped before completion
NCT00439309 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 69 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (95% lower).
The record links to 0 conditions, and to 2 interventions - of which Gelfoam/Thrombin is the first listed.
NCT00439309 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00439309 about?
NCT00439309 is a clinical study titled "Study to Evaluate Safety & Effectiveness of Vascular Sealant System". To evaluate a new vascular sealant compared to control for the control of suture line bleeding after vascular reconstructive surgery.
What is the current status of trial NCT00439309?
This trial is currently terminated. It is a NA study. The enrollment target is 69 participants. The study started on 2007-04. Estimated completion is 2008-05.
What interventions are being tested in trial NCT00439309?
The interventions under investigation include: Gelfoam/Thrombin (DEVICE), VascuSeal (DEVICE).
Who is sponsoring clinical trial NCT00439309?
This trial is sponsored by Integra LifeSciences Corporation, which has 60 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00439309's enrollment target sits among peer trials
69 1133rd of 2000 higher than 868 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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