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

NCT06095531 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-02-04

No results posted yet for this study

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.

Conditions

  • Craniotomy

Interventions

DEVICE

Tetranite for Cranial Flap Fixation (TN-CFF)

Bioresorbable bone adhesive for cranial flap fixation following a craniotomy.

Sponsors & Collaborators

  • RevBio

    lead INDUSTRY

Principal Investigators

  • Timothy R Smith, MD, PhD, MPH · Brigham and Women's Hospital

  • Madison Michael, MD · Semmes Murphey Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-18
Primary Completion
2025-12-08
Completion
2026-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06095531 on ClinicalTrials.gov