ACTIVE_NOT_RECRUITING

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

Conditions

Craniotomy cranial flap fixation bone adhesive bioresorbable

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Quick Facts

Study Start:2024-04-18

Study Completion:2026-06-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06095531

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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.	* Subject requires a procedure involving a translabyrinthine, transsphenoidal, transoral approach, or any procedure that penetrates the air sinus or mastoid air cells. Note: Superficial penetration of mastoid air cells is not an exclusion if cells were appropriately sealed (e.g., bone wax). * Subject has clinically significant hydrocephalus or clinical evidence of altered CSF dynamics. * Subject has undergone a previous, open intracranial neurosurgical procedure in the same anatomical location. (Note: stereotactic biopsy was not exclusionary). * Subject requires a craniectomy (the bone flap is not replaced during the current surgery). * Subject had radiation treatment to the surgical site, or standard fractionated radiation therapy was planned post index-procedure. (Note: stereotactic radiosurgery prior to the planned index procedure was not an exclusion criterion.) * 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. * Standard use of peri-operative steroids (i.e., corticosteroids) is permitted. Chronic steroid use (defined as daily use of corticosteroids for ≥ 8 weeks) for the purposes of reducing the side effects of chemotherapy and/or radiation therapy for cancer is not exclusionary unless the patient is deemed by the investigator to be suffering from steroid toxicity (i.e., Cushing's syndrome) manifested by symptoms and signs such as thin skin, striae, easy bruising, muscle atrophy, upper body obesity, severe fatigue, etc. Use of corticosteroids on a chronic basis (as defined previously) for purposes other than decreasing the symptoms of systemic chemotherapy is exclusionary unless those steroids were discontinued 4 weeks prior to the planned index procedure. * 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.

Inclusion Criteria

Exclusion Criteria

* 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.

* Subject requires a procedure involving a translabyrinthine, transsphenoidal, transoral approach, or any procedure that penetrates the air sinus or mastoid air cells. Note: Superficial penetration of mastoid air cells is not an exclusion if cells were appropriately sealed (e.g., bone wax).
* Subject has clinically significant hydrocephalus or clinical evidence of altered CSF dynamics.
* Subject has undergone a previous, open intracranial neurosurgical procedure in the same anatomical location. (Note: stereotactic biopsy was not exclusionary).
* Subject requires a craniectomy (the bone flap is not replaced during the current surgery).
* Subject had radiation treatment to the surgical site, or standard fractionated radiation therapy was planned post index-procedure. (Note: stereotactic radiosurgery prior to the planned index procedure was not an exclusion criterion.)
* 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.
* Standard use of peri-operative steroids (i.e., corticosteroids) is permitted. Chronic steroid use (defined as daily use of corticosteroids for ≥ 8 weeks) for the purposes of reducing the side effects of chemotherapy and/or radiation therapy for cancer is not exclusionary unless the patient is deemed by the investigator to be suffering from steroid toxicity (i.e., Cushing's syndrome) manifested by symptoms and signs such as thin skin, striae, easy bruising, muscle atrophy, upper body obesity, severe fatigue, etc. Use of corticosteroids on a chronic basis (as defined previously) for purposes other than decreasing the symptoms of systemic chemotherapy is exclusionary unless those steroids were discontinued 4 weeks prior to the planned index procedure.
* 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.

Contacts and Locations

Principal Investigator

Timothy R Smith, MD, PhD, MPH

PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Madison Michael, MD

PRINCIPAL_INVESTIGATOR

Semmes Murphey Clinic

Study Locations (Sites)

Brigham and Women's Hospital

Boston, Massachusetts, 02115

United States

Semmes Murphey Clinic

Memphis, Tennessee, 38120

United States

Collaborators and Investigators

Sponsor: RevBio

Timothy R Smith, MD, PhD, MPH, PRINCIPAL_INVESTIGATOR, Brigham and Women's Hospital
Madison Michael, MD, PRINCIPAL_INVESTIGATOR, Semmes Murphey Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-18

Study Completion Date2026-06-30

Study Record Updates

Study Start Date2024-04-18

Study Completion Date2026-06-30

Terms related to this study

Keywords Provided by Researchers

cranial flap fixation
bone adhesive
bioresorbable

Additional Relevant MeSH Terms

Craniotomy