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NCT01681030 · ClinicalTrials.gov registry record · Phase 2
The Fibrin Pad Cardiovascular Study
A Phase 2 study of Cardiovascular Disease, sponsored by Ethicon.
- Completed
- Registry status
- Phase 2
- Development phase
- 42
- Enrollment target
- 6
- Study locations
NCT01681030: Completed Phase 2 study of Cardiovascular Disease, sponsored by Ethicon.
NCT01681030 is a Phase 2 study of Cardiovascular Disease that has completed, run by Ethicon. The registered enrollment target is 42 participants, below the 2,697-participant average among 137 other Cardiovascular Disease trials with a reported enrollment target (98% lower). The trial reports 6 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01681030, a Phase 2 study of Cardiovascular Disease, has completed, sponsored by Ethicon.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 42 participants
- Enrollment target
- 6
- Study locations
Study Summary
This is a three-arm, randomized multicenter study evaluating the safety and effectiveness of EVARREST™ Fibrin Sealant Patch in controlling mild to moderate vascular anastomosis suture line bleeding in cardiovascular surgery.
Primary Outcome
Number of subjects achieving hemostasis at the Target Bleeding Site (TBS) at 3 minutes following treatment application, with no re-bleeding at the TBS any time prior to the initiation of final chest wall closur
Conditions Studied
Interventions
- OTHER Standard of Care
- BIOLOGICAL EVARREST™
- BIOLOGICAL Topical hemostat
Study Locations (6)
New Jersey
- Clinical Investigation Site #4 - Camden
- Clinical Investigation Site #1 - Paterson
New York
- Clinical Investigation Site #3 - New York
- Clinical Investigation Site #2 - New York
Indiana
- Clinical Investigation Site #5 - Indianapolis
Missouri
- Clinical Investigation Site #6 - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2012-08-01 |
| Est. Completion | 2013-09-03 |
| Phase | Phase 2 |
What the finished NCT01681030 record still lists
NCT01681030 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 2,697-participant average among 137 other Cardiovascular Disease trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Cardiovascular Disease appearing as the primary indexed condition, and to 3 interventions - of which Standard of Care is the first listed.
NCT01681030 lists 6 locations in 4 states (New Jersey, New York, Indiana).
Frequently Asked Questions
What is clinical trial NCT01681030 about?
NCT01681030 is a clinical study titled "The Fibrin Pad Cardiovascular Study". This is a three-arm, randomized multicenter study evaluating the safety and effectiveness of EVARREST™ Fibrin Sealant Patch in controlling mild to moderate vascular anastomosis suture line bleeding in cardiovascular surgery.
What is the current status of trial NCT01681030?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 42 participants. The study started on 2012-08-01. Estimated completion is 2013-09-03.
What conditions does trial NCT01681030 study?
This clinical trial studies the following conditions: Cardiovascular Disease.
What interventions are being tested in trial NCT01681030?
The interventions under investigation include: Standard of Care (OTHER), EVARREST™ (BIOLOGICAL), Topical hemostat (BIOLOGICAL).
Who is sponsoring clinical trial NCT01681030?
This trial is sponsored by Ethicon, which has 38 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01681030 being conducted?
This trial has 6 study locations across Indiana, Missouri, New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cardiovascular Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01681030's enrollment target sits among peer trials
42 116th of 137 higher than 21 of 137 other Cardiovascular Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cardiovascular Disease 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.
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