NCT06095531

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: RevBio · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Craniotomy

Interventions

Type	Name	Description
DEVICE	Tetranite for Cranial Flap Fixation (TN-CFF)	Bioresorbable bone adhesive for cranial flap fixation following a craniotomy.

Timeline

• Start date: 2024-04-18
• Primary completion: 2025-12-08
• Completion: 2026-06-30
• First posted: 2023-10-23
• Last updated: 2026-02-04

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study