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

NCT06095531 | Active Not Recruiting DMC FDA Device

• 1 other identifier: DVAL 21011
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

cranial flap fixation; bone adhesive; bioresorbable

Outcome Measures

Primary Outcomes (1)

• The primary endpoint is the rate of all serious adverse device and procedure related effects during the post procedure follow up period.

  Rate of all serious adverse device and procedure related effects from the time of fixation to 6 months post - procedure

  Time of fixation and 6 months post-procedure

Secondary Outcomes (9)

• Radiolucency data using CT imaging at the cranial flap cut lines.

  Throughout 12 Months post-procedure period

• Change in radiolucency using CT imaging at the cranial flap cut lines with respect to time.

  Throughout 12 Months post-procedure period

• Device-related adverse events.

  Throughout 12 Months post-procedure period

• Flap immobility determined clinical palpation of the cranial flap by an independent neurosurgeon.

  Time of fixation and 6 months post-procedure

• Flap immobility at 6 months and 12 months determined by clinical palpation of the cranial flap by the neurosurgeon and the patient.

  6 months and 12 months post-procedure

Other Outcomes (6)

• Neurological Exam using the Karnofsky Performance Scale (KPS)

  Throughout 12 Months post-procedure period

• Neurological Exam using the Neurologic Assessment in Neuro-Oncology (NANO) scale.

  Throughout 12 Months post-procedure period

• Wound healing will be evaluated at post-surgical visits and will result in one of the three results: Surgical Revision needed, Superficial dehiscence, Completely Healed.

  Throughout 12 Months post-procedure period

Study Arms (1)

Cranial flap replacement following a craniotomy using Tetranite for Cranial Flap Fixation (TN-CFF)

EXPERIMENTAL

All patients enrolled in study will receive the use of Tetranite (TN-CFF) for their cranial flap fixation following a craniotomy. The flap fixation will be assessed at various time points.

Device: Tetranite for Cranial Flap Fixation (TN-CFF)

Interventions

Tetranite for Cranial Flap Fixation (TN-CFF) DEVICE

Bioresorbable bone adhesive for cranial flap fixation following a craniotomy.

Cranial flap replacement following a craniotomy using Tetranite for Cranial Flap Fixation (TN-CFF)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects or representatives must have voluntarily signed the informed consent form before any study related procedures.
• Subjects can be any gender, but be between (and including) 18 and 75 years of age
• Subject is scheduled for a cranial procedure in the supratentorial location.
• Subject requires a procedure involving a Class I/clean wound (uninfected surgical wound in which no inflammation was encountered).
• Subject, and/or subject's family are able and willing to provide informed consent and HIPAA authorization.
• Subject is able and willing to meet all study requirements, including attending all post-index procedure assessment visits and radiological tests.
• Width of craniotomy kerf line \< 3mm for more than 75% of the bone flap border

You may not qualify if:

• Subject has clinically significant hydrocephalus or clinical evidence of altered CSF dynamics.
• Subject requires a craniectomy (the bone flap is not replaced during the current surgery).
• Subject has a condition with anticipated survival shorter than six months.
• Subject has undergone chemotherapy treatment, excluding hormonal therapy, within three weeks prior to the planned index procedure, or use of intracavitary chemotherapy wafer (BCNU) was planned, or chemotherapy treatment was planned within two weeks after the index procedure was performed.
• Subject receives warfarin, heparin, other anticoagulant agents on a daily basis and pre-surgical, standard of care drug wash-out did not occur.
• Subject is pregnant, breast-feeding, or intended to become pregnant during the course of the study.

Sponsors & Collaborators

• RevBio: lead

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Semmes Murphey Clinic

Memphis, Tennessee, 38120, United States

Location

Study Officials

• Timothy R Smith, MD, PhD, MPH

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

• Madison Michael, MD

  Semmes Murphey Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2023
• First Posted: October 23, 2023
• Study Start: April 18, 2024
• Primary Completion: December 8, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)