A Pilot Study to Evidence Improved Cranial Flap Fixation With a Bioresorbable Bone Adhesive (NCT06095531) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
A Pilot Study to Evidence Improved Cranial Flap Fixation With a Bioresorbable Bone Adhesive
United States20 participantsStarted 2024-04-18
Plain-language summary
This clinical pilot study will evaluate the use of a bioresorbable bone adhesive to improve cranial flap fixation at two study time points (at the time of fixation and 6 months). The aim of this Pilot Study is to demonstrate the safety and efficacy of the use of Tetranite for Cranial Flap Fixation (TN-CFF) to allow clinical study of the TN-CFF device in a greater number of patients.
Who can participate
Age range18 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subjects or representatives must have voluntarily signed the informed consent form before any study related procedures.
* Subjects can be any gender, but be between (and including) 18 and 75 years of age
* Subject is scheduled for a cranial procedure in the supratentorial location.
* Subject requires a procedure involving a Class I/clean wound (uninfected surgical wound in which no inflammation was encountered).
* Subject, and/or subject's family are able and willing to provide informed consent and HIPAA authorization.
* Subject is able and willing to meet all study requirements, including attending all post-index procedure assessment visits and radiological tests.
Intra-Operative Inclusion Criteria:
* Width of craniotomy kerf line \< 3mm for more than 75% of the bone flap border
Exclusion Criteria:
* Subject requires a procedure involving a translabyrinthine, transsphenoidal, transoral approach, or any procedure that penetrates the air sinus or mastoid air cells. Note: Superficial penetration of mastoid air cells is not an exclusion if cells were appropriately sealed (e.g., bone wax).
* Subject has clinically significant hydrocephalus or clinical evidence of altered CSF dynamics.
* Subject has undergone a previous, open intracranial neurosurgical procedure in the same anatomical location. (Note: stereotactic biopsy was not exclusionary).
* Subject requires a craniectomy (the bone flap is not replaced during the current surgery).
* Subject had radia…
What they're measuring
1
The primary endpoint is the rate of all serious adverse device and procedure related effects during the post procedure follow up period.
Timeframe: Time of fixation and 6 months post-procedure