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 range
18 Years – 75 Years
Sex
ALL
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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