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
6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2023-10-18; most recent amendment 2026-02-02.
Status change: Recruiting → Active, Not Recruiting2025-07-03
Status change: Not Yet Recruiting → Recruiting2024-06-03
Status change: Withheld → Not Yet Recruiting2023-12-19