CraniSeal Post Approval Study
Recruiting
Phase 4
Interventional Study
Leak, Cerebrospinal Fluid
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 224 (estimated)
- Sponsor
- Pramand LLC · Industry
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About This Trial
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 p…
Trial Locations
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Eligibility Criteria
General Inclusion Criteria:
1. Patient is ≥ 18 years of age
2. Patient is scheduled for an elective infratentorial or supratentorial cranial procedure under general anesthesia that entails a dural incision
3. Patient requires a procedure involving surgical wound classification Class I/Clean
4. Pati…
Contacts