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NCT00388284 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy Study Comparing Thrombin for Arterial Sealing
A Phase 3 study, sponsored by Vascular Solutions.
- Completed
- Registry status
- Phase 3
- Development phase
- 270
- Enrollment target
NCT00388284 is a Phase 3 study that has completed, run by Vascular Solutions. The registered enrollment target is 270 participants.
The verdict
NCT00388284, a Phase 3 study, has completed, sponsored by Vascular Solutions.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 270 participants
- Enrollment target
Study Summary
This trial is designed as a prospective, multi-center, randomized, double blinded clinical trial to evaluate the safety and efficacy of the Thrombin VSI. An immunological sub-study to assess antibody and coagulation changes in the subjects following exposure to the Vascular Solutions Diagnostic Duett Pro manufactured with Thrombin VSI and Thrombin JMI will be conducted as a component of this trial with a subset of the enrolled study subjects. Two hundred seventy (270) subjects will be enrolled in this trial. A minimum of 50% of the subjects will be interventional subjects and up to 50% will be diagnostic subjects. All 270 subjects will provide blood specimens at baseline and at the 30 day follow-up visit for evaluation in the immunologic sub-study. Within the 270 subjects enrolled, a minimum of 45 subjects treated with the Thrombin VSI and a minimum of 45 subjects treated with the Thrombin JMI will provide blood specimens at the 60 day follow-up visit to be evaluated in the immunologic sub-study. The primary efficacy objective is to demonstrate that the device time-to-hemostasis for the study group treated with the sealing device manufactured with Thrombin VSI is non-inferior to the study group treated with the sealing device manufactured with Thrombin JMI. The primary safety objective is to demonstrate a device-related major complication rate for the study group treated with the sealing device manufactured with Thrombin VSI that is non-inferior to the device-related major complication rate observed for the study group treated with the sealing device manufactured with Thrombin JMI.
Interventions
- DEVICE Arterial Sealing
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 270 participants |
| Start Date | 2006-08 |
| Est. Completion | 2007-03 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00388284
The ClinicalTrials.gov registry entry for NCT00388284 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 270 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vascular Solutions, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Arterial Sealing is the first listed.
NCT00388284 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00388284 about?
NCT00388284 is a clinical study titled "Safety and Efficacy Study Comparing Thrombin for Arterial Sealing". This trial is designed as a prospective, multi-center, randomized, double blinded clinical trial to evaluate the safety and efficacy of the Thrombin VSI. An immunological sub-study to assess antibody and coagulation changes in the subjects following exposure to the Vascular Solutions Diagnostic Duet...
What is the current status of trial NCT00388284?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 270 participants. The study started on 2006-08. Estimated completion is 2007-03.
What interventions are being tested in trial NCT00388284?
The interventions under investigation include: Arterial Sealing (DEVICE).
Who is sponsoring clinical trial NCT00388284?
This trial is sponsored by Vascular Solutions, which has 7 total clinical trials registered on ClinicalTrials.gov.
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