A Pilot Clinical Study to Evidence Improved Cranial Flap Fixation With a Bioresorbable Bone Adhesive
ConditionCraniotomy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorRevBio
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Tetranite for Cranial Flap Fixation (TN-CFF)
Treatment groups
15 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov