Actively Recruiting
A Pilot Clinical Study to Evidence Improved Cranial Flap Fixation With a Bioresorbable Bone Adhesive
Led by RevBio · Updated on 2025-03-11
15
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Pilot Clinical Study to Evidence Improved Cranial Flap Fixation With a Bioresorbable Bone Adhesive
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- Width of craniotomy kerf line < 3mm for more than 75% of the bone flap border
You will not qualify if you...
- Subject requires a procedure involving a translabyrinthine, transsphenoidal, transoral approach, or any procedure that penetrates the air sinus or mastoid air cells (superficial penetration is allowed if appropriately sealed)
- 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 (stereotactic biopsy allowed)
- Subject requires a craniectomy where the bone flap is not replaced during surgery
- Subject had radiation treatment to the surgical site or planned standard fractionated radiation therapy post-procedure (stereotactic radiosurgery prior to procedure allowed)
- Subject requires a craniotomy across the sinus with adhesive applied adjacent to or within the sinus
- Subject has a condition with expected survival shorter than six months
- Subject underwent chemotherapy (excluding hormonal therapy) within three weeks prior to procedure or planned chemotherapy within two weeks after procedure
- Chronic corticosteroid use for non-cancer reasons, unless discontinued 4 weeks prior to procedure
- Subject receives warfarin, heparin, or other daily anticoagulants without standard pre-surgical wash-out
- Subject is pregnant, breastfeeding, or intends to become pregnant during the study
AI-Screening
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Trial Site Locations
Total: 1 location
1
Bristol Southmead Hospital
Bristol, United Kingdom, BS10 5NB
Actively Recruiting
Research Team
B
Brian Hess
CONTACT
S
Sarah Moss
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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