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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 is a Phase 4 study of Leak, Cerebrospinal Fluid that is actively recruiting participants, run by Pramand. The registered enrollment target is 224 participants. The trial reports 8 study locations across 7 states.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06406790
The ClinicalTrials.gov registry entry for NCT06406790 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 224 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pramand, which has 1 total studies on file at ClinicalTrials.gov.
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 reports 8 study locations spanning 7 distinct geographic areas - top geographies include 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.
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