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NCT00652314 · ClinicalTrials.gov registry record · Phase 4
Evaluation of an Absorbable Surgical Hemostatic Agent: Thrombi-Gel® Versus Gelfoam-Thrombin
A Phase 4 study of Operation Site Bleed, sponsored by Vascular Solutions.
- Completed
- Registry status
- Phase 4
- Development phase
- 97
- Enrollment target
- 7
- Study locations
NCT00652314 is a Phase 4 study of Operation Site Bleed that has completed, run by Vascular Solutions. The registered enrollment target is 97 participants. The trial reports 7 study locations across 6 states.
The verdict
NCT00652314, a Phase 4 study of Operation Site Bleed, has completed, sponsored by Vascular Solutions.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 97 participants
- Enrollment target
- 7
- Study locations
Study Summary
This trial is designed as a prospective, multi-center, randomized, feasibility clinical trial to evaluate the safety and efficacy of Thrombi-Gel as an absorbable surgical hemostat. Within this clinical evaluation, Thrombi-Gel will be compared to the current standard of care, a gelatin sponge (Gelfoam) plus Thrombin JMI, by using a 2:1 randomization ratio. Subjects will be randomized to one of two (2) treatment groups. One (1) group will be treated with Thrombi-Gel, while one (1) group will be treated with the gelatin sponge plus thrombin. All study data will be analyzed according to the subjects' assigned randomization group assignment, regardless of the treatment actually delivered.
Conditions Studied
Interventions
- DEVICE Thrombi-Gel
Study Locations (7)
Texas
- Southwest Regional Clinical Research - Lubbock
- Texas Tech University Health Sciences Center - Lubbock
Illinois
- Southern Illinois University School of Medicine - Springfield
Massachusetts
- Lahey Clinic - Burlington
Michigan
- Michigan Vascular Research Center - Flint
New Jersey
- Hackensack University Medical Center - Hackensack
South Dakota
- Sanford Clinic - Sioux Falls
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 97 participants |
| Start Date | 2008-03 |
| Est. Completion | 2010-01 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00652314
The ClinicalTrials.gov registry entry for NCT00652314 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 97 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 1 condition, with Operation Site Bleed appearing as the primary indexed condition, and to 1 intervention - of which Thrombi-Gel is the first listed.
NCT00652314 reports 7 study locations spanning 6 distinct geographic areas - top geographies include Texas, Illinois, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT00652314 about?
NCT00652314 is a clinical study titled "Evaluation of an Absorbable Surgical Hemostatic Agent: Thrombi-Gel® Versus Gelfoam-Thrombin". This trial is designed as a prospective, multi-center, randomized, feasibility clinical trial to evaluate the safety and efficacy of Thrombi-Gel as an absorbable surgical hemostat. Within this clinical evaluation, Thrombi-Gel will be compared to the current standard of care, a gelatin sponge (Gelfo...
What is the current status of trial NCT00652314?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 97 participants. The study started on 2008-03. Estimated completion is 2010-01.
What conditions does trial NCT00652314 study?
This clinical trial studies the following conditions: Operation Site Bleed.
What interventions are being tested in trial NCT00652314?
The interventions under investigation include: Thrombi-Gel (DEVICE).
Who is sponsoring clinical trial NCT00652314?
This trial is sponsored by Vascular Solutions, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00652314 being conducted?
This trial has 7 study locations across Illinois, Massachusetts, Michigan, New Jersey, South Dakota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.