CraniotomyNCT06780852
A Pilot Clinical Study to Evidence Improved Cranial Flap Fixation With a Bioresorbable Bone Adhesive
A study testing Tetranite for Cranial Flap Fixation (TN-CFF) in people with Craniotomy, run by RevBio at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Craniotomy
- What is being tested?
- Tetranite for Cranial Flap Fixation (TN-CFF)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Jan 2025to 15 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Intra-Operative Inclusion Criteria:
- Width of craniotomy kerf line < 3mm for more than 75% of the bone flap border
Who cannot join
- 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 requires a craniotomy across the sinus for which Tetranite is applied adjacent to or within the sinus to fixate the cranial flap.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Bristol Southmead Hospital
Bristol, BS10 5NB
Beverly Faulkner, 0117 41 45739, beverley.faulkner@nbt.nhs.uk
Deanna Stephens, deanna.stephens@nbt.nhs.uk
About this study
Official title: A Pilot Clinical Study to Evidence Improved Cranial Flap Fixation With a Bioresorbable Bone Adhesive Based on Imaging and Patient Reported Outcomes
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.
Read the 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
- Being tested
- Tetranite for Cranial Flap Fixation (TN-CFF)
- Keywords
- cranial flap fixation, bone adhesive, bioresorbable
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tetranite for Cranial Flap Fixation (TN-CFF)Device
Bioresorbable bone adhesive for cranial flap fixation following a craniotomy.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Device: Tetranite for Cranial Flap Fixation (TN-CFF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Time of fixation and 6 months post-procedure.
Secondary outcomes (8)
Radiolucency data using CT imaging at the cranial flap cut lines.
Radiolucency data using CT imaging at the cranial flap cut lines and the change of radiolucency with respect to time.
Measured: Throughout 12 Months post-procedure period.
Device-related adverse events
Device-related adverse events included all adverse events classified as definitely, probably, possibly, or undetermined relation to the device or procedure.
Measured: Throughout 12 Months post-procedure period.
Flap immobility determined clinical palpation of the cranial flap by an independent neurosurgeon.
Flap immobility will be determined by an independent neurosurgeon.
Measured: 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.
Flap immobility will be determined by the surgeon and the patient.
Measured: 6 months and 12 months post-procedure.
Translation of the flap based on CT scan.
Translation of the flap based on CT scan
Measured: Throughout 12 Months post-procedure period.
Patient Reported outcome using PROMIS10
Subject satisfaction after TN-CFF was used for cranial flap fixation using a validated questionnaire for overall health.
Measured: Throughout 12 Months post-procedure period.
Patient Reported outcome using the 36 Item Short Form Survey (SF-36).
Subject satisfaction after TN-CFF was used for cranial flap fixation using a validated questionnaire for overall quality of life measures.
Measured: Throughout 12 Months post-procedure period.
Patient Reported outcome as measured on a Visual Analog Scale of pain intensity.
Subject satisfaction after TN-CFF is used for cranial flap fixation (i.e., level of headache pain)
Measured: Throughout 12 Months post-procedure period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start15 Jan 2025
- Primary completion15 Jun 2026 (estimated)
- Study completion15 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CraniotomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RevBio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kumar Abhinav, BSc MBBS MD FRCS(Neurosurgery), Principal investigator, Bristol Southmead Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06780852
- Sponsor's protocol ID
- DVAL22023
- Status last verified
- Mar 2025
- First submitted
- 13 Jan 2025
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is no plan to share IPD at this time. Study results will be published in a journal after study completion.
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Clinical Study to Evidence Improved Cranial Flap Fixation With a Bioresorbable Bone Adhesive Based on Imaging and Patient Reported Outcomes
- ClinicalTrials.gov ID
- NCT06780852
- Acronym / sponsor ID
- DVAL22023
- Conditions
- Craniotomy
- Keywords
- cranial flap fixation, bone adhesive, bioresorbable
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- RevBioIndustry (pharma, biotech, devices)
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 15 Jun 2026 (estimated)
- Study completion
- 15 Jan 2027 (estimated)
- First posted
- 17 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Hardware Augmentation | Experimental | Device: Tetranite for Cranial Flap Fixation (TN-CFF)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). |
| Standalone | Experimental | Device: Tetranite for Cranial Flap Fixation (TN-CFF)The patients will undergo cranial flap fixation using only Tetranite (TN-CFF) for Cranial Flap Fixation. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tetranite for Cranial Flap Fixation (TN-CFF)Bioresorbable bone adhesive for cranial flap fixation following a craniotomy. | Device | Hardware Augmentation, Standalone |
Primary outcome
The primary endpoint is the rate of all serious adverse device and procedure related effects during the post procedure follow up period.
Time frame: Time of fixation and 6 months post-procedure.
Rate of all serious adverse device and procedure related effects from the time of fixation to 6 months post - procedure
8 secondary outcomes
Radiolucency data using CT imaging at the cranial flap cut lines.
Time frame: Throughout 12 Months post-procedure period.
Device-related adverse events
Time frame: Throughout 12 Months post-procedure period.
Flap immobility determined clinical palpation of the cranial flap by an independent neurosurgeon.
Time frame: 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.
Time frame: 6 months and 12 months post-procedure.
Translation of the flap based on CT scan.
Time frame: Throughout 12 Months post-procedure period.
Patient Reported outcome using PROMIS10
Time frame: Throughout 12 Months post-procedure period.
Patient Reported outcome using the 36 Item Short Form Survey (SF-36).
Time frame: Throughout 12 Months post-procedure period.
Patient Reported outcome as measured on a Visual Analog Scale of pain intensity.
Time frame: Throughout 12 Months post-procedure period.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- Individual participant dataSharing planned: No. There is no plan to share IPD at this time. Study results will be published in a journal after study completion.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kumar Abhinav, BSc MBBS MD FRCS(Neurosurgery) principal investigator
Bristol Southmead Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tetranite for Cranial Flap Fixation (TN-CFF) in people with Craniotomy, run by RevBio at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brian Hess (617-460-6675, bhess@revbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint is the rate of all serious adverse device and procedure related effects during the post procedure follow up period. (time frame: Time of fixation and 6 months post-procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.