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RECRUITING
NCT06780852
NA

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

Sponsor: RevBio

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

15

Start Date

2025-01-15

Completion Date

2027-01-15

Last Updated

2025-03-11

Healthy Volunteers

No

Conditions

Interventions

DEVICE

Tetranite for Cranial Flap Fixation (TN-CFF)

Bioresorbable bone adhesive for cranial flap fixation following a craniotomy.

Locations (1)

Bristol Southmead Hospital

Bristol, United Kingdom