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NCT02457546 · ClinicalTrials.gov registry record · Phase 3
The EVICEL® Neurosurgery Phase III Study
A Phase 3 study, sponsored by Ethicon.
- Completed
- Registry status
- Phase 3
- Development phase
- 234
- Enrollment target
NCT02457546: Completed Phase 3 study, sponsored by Ethicon.
NCT02457546 is a Phase 3 study that has completed, run by Ethicon. The registered enrollment target is 234 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (70% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02457546, a Phase 3 study, has completed, sponsored by Ethicon.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 234 participants
- Enrollment target
Study Summary
The objective of this study is to evaluate the safety and efficacy of EVICEL® Fibrin Sealant (Human) for use as an adjunct to sutured dural repair in cranial surgery.
Primary Outcome
The primary endpoint was the proportion of subjects that had no inter-operative CSF leak following Valsalva maneuver and no CSF leak or pseudomeningocele in the surgical area during the 30-day follow-up period
Interventions
- BIOLOGICAL EVICEL Fibrin Sealant
- DEVICE Hydrogel sealant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 234 participants |
| Start Date | 2015-07-01 |
| Est. Completion | 2017-10-12 |
| Phase | Phase 3 |
What the finished NCT02457546 record still lists
NCT02457546 is an interventional study that assigns participants to a tested intervention. The registered 234 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (70% lower).
The record links to 0 conditions, and to 2 interventions - of which EVICEL Fibrin Sealant is the first listed.
NCT02457546 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02457546 about?
NCT02457546 is a clinical study titled "The EVICEL® Neurosurgery Phase III Study". The objective of this study is to evaluate the safety and efficacy of EVICEL® Fibrin Sealant (Human) for use as an adjunct to sutured dural repair in cranial surgery.
What is the current status of trial NCT02457546?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 234 participants. The study started on 2015-07-01. Estimated completion is 2017-10-12.
What interventions are being tested in trial NCT02457546?
The interventions under investigation include: EVICEL Fibrin Sealant (BIOLOGICAL), Hydrogel sealant (DEVICE).
Who is sponsoring clinical trial NCT02457546?
This trial is sponsored by Ethicon, which has 38 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02457546's enrollment target sits among peer trials
234 1297th of 2000 higher than 703 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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