NCT06406790 · Pramand LLC
CraniSeal Post Approval Study
What this study is about
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.
View original scientific description
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.
Interventions
DEVICE
CraniSeal
CraniSeal is a PEG Dural Sealant
DEVICE
DuraSeal
DuraSeal is a PEG Dural Sealant
Primary outcome measures
Absence of CSF Leaks
Time frame: 90 days
absence of CSF leaks on study
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Patient is ≥ 18 years of age
- Patient is scheduled for an elective infratentorial or supratentorial cranial procedure that entails a dural incision.
- Patient requires a procedure involving surgical wound classification Class I/Clean
- Patient signs a written Informed Consent form to participate in the study, prior to any study mandated determinations or procedures.
- Patients who are able to comply with study requirements.
Exclusion criteria
- Patient requires a procedure involving translabyrinthine, transsphenoidal, transoral and/ or any procedure that penetrates the air sinus or mastoid air cells; superficial penetration of air cells are not excluded
- Patient has had a prior intracranial neurosurgical procedure in the same anatomical location.
- Patient with diagnosis of severely altered renal (creatinine levels \> 2.0 mg/dL) or hepatic (total bilirubin \> 2.5 mg/dL) function
- Patient diagnosed with a compromised immune system or autoimmune disease (WBC
Where
- Los Angeles, California
- Jacksonville, Florida
- Tampa, Florida
- Augusta, Georgia
- Boston, Massachusetts
- Rochester, Minnesota
- Buffalo, New York
- Greenville, South Carolina
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 20, 2026 · Source of record for eligibility and locations