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

NCT06780852 | Recruiting DMC FDA Device

• 1 other identifier: DVAL22023
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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 (8)

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

  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 as determined by clinical palpation of the cranial flap by the neurosurgeon and the patient.

  6 months and 12 months post-procedure.

• Translation of the flap based on CT scan.

  Throughout 12 Months post-procedure period.

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

  Throughout 12 Months post-procedure period

Study Arms (2)

Hardware Augmentation

EXPERIMENTAL

The first 5 patients will undergo cranial flap placement using currently marketed metal fixation (plates and screws). The kerf line and burr holes will then be filled with Tetranite (TN-CFF).

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

Standalone

EXPERIMENTAL

The patients will undergo cranial flap fixation using only Tetranite (TN-CFF) for Cranial Flap Fixation.

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.

Hardware Augmentation; Standalone

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 requires a craniotomy across the sinus for which Tetranite is applied adjacent to or within the sinus to fixate the cranial flap.
• 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 (1)

Bristol Southmead Hospital

Bristol, BS10 5NB, United Kingdom

RECRUITING

Study Officials

• Kumar Abhinav, BSc MBBS MD FRCS(Neurosurgery)

  Bristol Southmead Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brian Hess

CONTACT

617-460-6675; bhess@revbio.com

Sarah Moss

CONTACT

281-795-1812; smoss@primepathmedtech.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This will be a single-center, two-arm, prospective study in which 15 qualified patients in need of a cranial flap fixation following a craniotomy will be enrolled. To begin the study, 5 patients will undergo cranial flap fixation using currently. marketed hardware (standard of care), with TN-CFF used to augment the fixation hardware and fill the kerf line. After the completion of the first 5 patients, 10 patients will undergo cranial flap fixation using only Tetranite for Cranial Flap Fixation (TN-CFF).

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: January 17, 2025
• Study Start: January 15, 2025
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): January 15, 2027
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)