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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: Completed Phase 4 study of Operation Site Bleed, sponsored by Vascular Solutions.
NCT00652314 is a Phase 4 study of Operation Site Bleed that has completed, run by Vascular Solutions. The registered enrollment target is 97 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (81% lower). The trial reports 7 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Evaluation for hemostasis began immediately following application of the safety product. Hemostasis assessments were to be made every minute for the first 10 minutes post application. If hemostasis was not observed within 10 minutes, the treatment site was to be monitored and the research teams were asked to record the specific number of minutes until hemostasis was observed.
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 |
What the finished NCT00652314 record still lists
NCT00652314 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 97 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (81% lower).
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 lists 7 locations in 6 states (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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00652314's enrollment target sits among peer trials
97 861st of 2000 higher than 1,138 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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