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Recruiting NCT06406790

CraniSeal Post Approval Study

Phase IV Interventional Leak, Cerebrospinal Fluid

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CraniSeal, DuraSeal.
Who it may be relevant to
Registry conditions: Leak, Cerebrospinal Fluid. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Multicenter, Single-Blind, Prospective Randomized Post-Approval Study Comparing the Safety and Effectiveness of CraniSeal Dural Sealant to DuraSeal Dural Sealant for Dural Sealing in Elective Cranial Surgery

Overview

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.

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]

Eligibility criteria

General Inclusion Criteria:

  • Patient is ≥ 18 years of age
  • Patient is scheduled for an elective infratentorial or supratentorial cranial procedure under general anesthesia 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.

General 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 count less than 4000/uL or greater than 20,000/uL)
  • Patients undergoing cranial procedures involving petrous bone drilling
  • Patients with traumatic injuries to the head or dural disease in planned dural closure area
  • Patients who are pregnant or lactating
  • Patient with an active infection
  • Patient is undergoing cranial procedures involving non-autologous duraplasty material that are not collagen based
  • Patients requiring re-opening of planned surgical area within 90 days after surgery.
  • Patient with a known allergy to FD\&C Blue #1 dye
  • Patient is not able to tolerate multiple Valsalva maneuvers, or transient elevation of CSF pressure during Valsalva maneuvers is not possible (e.g. the presence of a temporary or permanent CSF shunt
  • Presence of hydrocephalus
  • Patient with a diagnosis of uncontrolled diabetes (e.g., persistent HbA1c elevation of >9% despite standard diabetes care),
  • Patient has a documented, uncorrectable clinically significant coagulopathy (e.g., PTT>37 seconds or INR >1.5 units)
  • Patient is not likely to comply with the follow-up evaluation schedule.
  • Contraindications to both an MRI and CT scan.
  • Patients participating in any investigational device study within 30 days or currently receiving an investigational drug/biologic therapy. (Observational studies on FDA approved products are not applicable)
  • Patients diagnosed with Meningiomatosis (multiple meningiomas)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 8 centers
  • Keck Medical Center at USC — Los Angeles
  • Mayo Clinic — Jacksonville
  • Tampa General Hospital — Tampa
  • Augusta University — Augusta
  • Brigham and Women's Hospital — Boston
  • Mayo Clinic — Rochester
  • Jacobs Institute — Buffalo
  • Prisma Health — Greenville

Identifiers

NCT: NCT06406790 · PRA-CT-0003

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗