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NCT06406790 · ClinicalTrials.gov registry record · Phase 4
CraniSeal Post Approval Study
A Phase 4 study of Leak, Cerebrospinal Fluid, sponsored by Pramand.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 224
- Enrollment target
- 8
- Study locations
NCT06406790: Recruiting Phase 4 study of Leak, Cerebrospinal Fluid, sponsored by Pramand.
NCT06406790 is a Phase 4 study of Leak, Cerebrospinal Fluid that is actively recruiting participants, run by Pramand. The registered enrollment target is 224 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (57% lower). The trial reports 8 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06406790, a Phase 4 study of Leak, Cerebrospinal Fluid, is actively recruiting participants, sponsored by Pramand.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 224 participants
- Enrollment target
- 8
- Study locations
Study Summary
To collect post-approval data comparing the safety and effectiveness of CraniSeal Dural Sealant to DuraSeal Dural Sealant. The study has been powered specifically to determine whether the CraniSeal device when used as an adjunct to sutured dural closure following elective cranial surgery is no worse than (i.e., non-inferior) to the DuraSeal device with respect to proportion of subjects free from post-operative cerebrospinal fluid (CSF) leaks. Additional safety outcomes (i.e., surgical site infections and adverse events/device-related adverse events) will also be captured and compared.
Primary Outcome
absence of CSF leaks on study
Conditions Studied
Interventions
- DEVICE CraniSeal
- DEVICE DuraSeal
Study Locations (8)
Florida
- Mayo Clinic - Jacksonville
- Tampa General Hospital - Tampa
California
- Keck Medical Center at USC - Los Angeles
Georgia
- Augusta University - Augusta
Massachusetts
- Brigham and Women's Hospital - Boston
Minnesota
- Mayo Clinic - Rochester
New York
- Jacobs Institute - Buffalo
South Carolina
- Prisma Health - Greenville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 224 participants |
| Start Date | 2024-05-29 |
| Est. Completion | 2027-02 |
| Phase | Phase 4 |
What NCT06406790 shows while recruiting
NCT06406790 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 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (57% lower).
The record links to 1 condition, with Leak, Cerebrospinal Fluid appearing as the primary indexed condition, and to 2 interventions - of which CraniSeal is the first listed.
NCT06406790 lists 8 locations in 7 states (Florida, California, Georgia).
Frequently Asked Questions
What is clinical trial NCT06406790 about?
NCT06406790 is a clinical study titled "CraniSeal Post Approval Study". To collect post-approval data comparing the safety and effectiveness of CraniSeal Dural Sealant to DuraSeal Dural Sealant. The study has been powered specifically to determine whether the CraniSeal device when used as an adjunct to sutured dural closure following elective cranial surgery is no worse...
What is the current status of trial NCT06406790?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 224 participants. The study started on 2024-05-29. Estimated completion is 2027-02.
What conditions does trial NCT06406790 study?
This clinical trial studies the following conditions: Leak, Cerebrospinal Fluid.
What interventions are being tested in trial NCT06406790?
The interventions under investigation include: CraniSeal (DEVICE), DuraSeal (DEVICE).
Who is sponsoring clinical trial NCT06406790?
This trial is sponsored by Pramand, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06406790 being conducted?
This trial has 8 study locations across California, Florida, Georgia, Massachusetts, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06406790's enrollment target sits among peer trials
224 379th of 2000 higher than 1,619 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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