RECRUITING

CraniSeal Post Approval Study

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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., surgical site infections and adverse events/device-related adverse events) will also be captured and compared.

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

Quick Facts

Study Start:2024-05-29

Study Completion:2026-02

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06406790

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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 synthetic or non-autologous duraplasty material that are not collagen based * Patient with a known allergy to FD\&C Blue #1 dye * Patient is not able to tolerate multiple Valsalva maneuvers, or an intraoperative CSF shunt does not allow for transient elevation of CSF pressure during Valsalva maneuvers. * 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.

Inclusion Criteria

Exclusion 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.

* 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 synthetic or non-autologous duraplasty material that are not collagen based
* Patient with a known allergy to FD\&C Blue #1 dye
* Patient is not able to tolerate multiple Valsalva maneuvers, or an intraoperative CSF shunt does not allow for transient elevation of CSF pressure during Valsalva maneuvers.
* 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.

Contacts and Locations

Study Contact

M Pace

CONTACT

6172335873

mike.pace@pramandllc.com

Study Locations (Sites)

Brigham and Women's Hospital

Boston, Massachusetts, 02115

United States

Jacobs Institute

Buffalo, New York, 14203

United States

Prisma Health

Greenville, South Carolina, 29605

United States

Collaborators and Investigators

Sponsor: Pramand LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-05-29

Study Completion Date2026-02

Study Record Updates

Study Start Date2024-05-29

Study Completion Date2026-02

Terms related to this study

Additional Relevant MeSH Terms

Leak, Cerebrospinal Fluid