Clinical Trial

A Pilot Clinical Study to Evidence Improved Cranial Flap Fixation With a Bioresorbable Bone Adhesive

Recruiting
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Record status
This record was last updated March 11, 2025 (before its estimated June 15, 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-01-13.
Trial Details
NCT Number NCT06780852
Lead Sponsor RevBio
Conditions Craniotomy
Enrollment 15 participants
Start Date 2025-01-15
Primary Completion 2026-06-15 (estimated)
Study Completion 2027-01-15 (estimated)
Updated on ClinicalTrials.gov 2025-03-11