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

Craniotomy Clinical Trial

Official title:
A Pilot Clinical Study to Evidence Improved Cranial Flap Fixation With a Bioresorbable Bone Adhesive Based on Imaging and Patient Reported Outcomes

Clinical Trial 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.

Clinical Trial Description

The primary endpoint is safety during the post procedure follow up period. This endpoint will be evaluated through the rate of all serious adverse device and procedure related effects from the time of fixation to 6 months post-procedure. The secondary endpoints include efficacy evaluated through radiolucency data using CT imaging at the cranial flap cut lines and the change of radiolucency with respect to time, device related adverse events, flap immobility at time of fixation, six months and 12 months, evaluation of flap translation and patient reported outcome measures. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06095531
Study type Interventional
Source RevBio
Contact Brian Hess
Phone 617-460-6675
Email bhess@revbio.com
Status Recruiting
Phase N/A
Start date April 18, 2024
Completion date March 30, 2025
View Details
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