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NCT02891070 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of FS VH S/D 500 S-apr (Tisseel) as an Adjunct to Sutured Dural Repair in Cranial Surgery
A Phase 3 study, sponsored by Baxter Healthcare Corporation.
- Completed
- Registry status
- Phase 3
- Development phase
- 224
- Enrollment target
NCT02891070: Completed Phase 3 study, sponsored by Baxter Healthcare Corporation.
NCT02891070 is a Phase 3 study that has completed, run by Baxter Healthcare Corporation. The registered enrollment target is 224 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (71% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02891070, a Phase 3 study, has completed, sponsored by Baxter Healthcare Corporation.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 224 participants
- Enrollment target
Study Summary
The objective of this study is to evaluate the safety and efficacy of FS VH S/D 500 s-apr for use as an adjunct to sutured dural repair in cranial surgery.
Primary Outcome
Participants who have no intra-operative CSF leak from dural repair after up to two applications during Valsalva maneuver (25 cm H2O for up to 5 - 10 seconds), or post-operative CSF leak within 30 (+3) days post-operatively. The Valsalva maneuver was performed by the anaesthesiologist to increase the intra-thoracic pressure (e.g., by increasing the positive end-expiratory pressure or by giving a large tidal volume and holding the inflating pressure) to approximately 25 cm H2O, constantly for up
Interventions
- DRUG FS VH S/D 500 s-apr
- DEVICE DuraSeal Dural Sealant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 224 participants |
| Start Date | 2016-10-11 |
| Est. Completion | 2018-08-22 |
| Phase | Phase 3 |
What the finished NCT02891070 record still lists
NCT02891070 is an interventional study that assigns participants to a tested intervention. The registered 224 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 (71% lower).
The record links to 0 conditions, and to 2 interventions - of which FS VH S/D 500 s-apr is the first listed.
NCT02891070 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02891070 about?
NCT02891070 is a clinical study titled "Efficacy and Safety of FS VH S/D 500 S-apr (Tisseel) as an Adjunct to Sutured Dural Repair in Cranial Surgery". The objective of this study is to evaluate the safety and efficacy of FS VH S/D 500 s-apr for use as an adjunct to sutured dural repair in cranial surgery.
What is the current status of trial NCT02891070?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 224 participants. The study started on 2016-10-11. Estimated completion is 2018-08-22.
What interventions are being tested in trial NCT02891070?
The interventions under investigation include: FS VH S/D 500 s-apr (DRUG), DuraSeal Dural Sealant (DEVICE).
Who is sponsoring clinical trial NCT02891070?
This trial is sponsored by Baxter Healthcare Corporation, which has 46 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02891070's enrollment target sits among peer trials
224 1317th of 2000 higher than 684 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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