CraniotomyNCT07452549
Safety and Effectiveness of TETRANITE Bone Adhesive for Cranial Flap Fixation Compared to Traditional Metal Hardware
A study testing Tetranite for Cranial Flap Fixation in people with Craniotomy, run by RevBio.
Trial summary
The aim of this study is to demonstrate the safety and efficacy of TETRANITE, a bioresorbable bone adhesive, for Cranial Flap Fixation as compared to traditional metal hardware. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Craniotomy
- What is being tested?
- Tetranite for Cranial Flap Fixation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 204 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2026to 15 Dec 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject, and/or subject's family are able and willing to provide informed consent and HIPAA authorization prior to any study related procedures.
- Subjects can be any gender, but be between (and including) 18 and 80 years of age
- Subject is scheduled for a cranial procedure that requires the creation of a bone flap or replacement of a bone flap (i.e., cranioplasty)
- Subject is scheduled for a cranial procedure in the supratentorial location.
- Subject is able and willing to meet all study requirements, including attending all post-index procedure assessment visits and radiological tests.
- Pre-operative CT scan for craniotomy patients must be less than or equal to 0.625 mm slice thickness and pixel spacing. It shall include the skull in native condition near the planned flap site DICOM export must be thin sliced reconstruction in the bone window.
- Intra-Operative Inclusion Criteria:
- Width of craniotomy kerf line < 3mm for more than 75% of the bone flap border.
Who cannot join
- Subject has undergone a previous, open intracranial neurosurgical procedure in the same anatomical location. (Note: stereotactic biopsy is not exclusionary).
- Subject requires a craniectomy (the bone flap is not replaced during the current surgery).
- Subject has had radiation treatment to the surgical site within the past year, or standard fractionated radiation therapy was planned within 2 weeks post index-procedure. (Note: stereotactic radiosurgery prior to the planned index procedure was not an exclusion criterion.)
- 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 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.
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- Subject has a condition with anticipated survival shorter than one year.
- 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.
- Current infection (either superficial or deep) at the planned operative site
- Sepsis diagnosed within one week before the planned index procedure
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
The aim of this study is to demonstrate the safety and efficacy of TETRANITE, a bioresorbable bone adhesive, for Cranial Flap Fixation as compared to traditional metal hardware.
Read the detailed description
This two arm study will assess the safety and efficacy of TETRANITE, a bioresorbable bone adhesive, for Cranial Flap Fixation as compared to traditional metal hardware. The control arm for this study is the standard of care plating system. Participants will be randomly assigned to either the TETRANITE arm, or the standard of care plating system arm. Participants will generally follow their standard of care follow-up for surgery for one year.
- Conditions
- Craniotomy
- Being tested
- Tetranite for Cranial Flap Fixation, Standard of Care Plating System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tetranite for Cranial Flap FixationCombination product
Tetranite for Cranial Flap Fixation is a bioresorbable bone adhesive that can be used to re-adhere the cranial flap following a craniotomy.
Standard of Care Plating SystemDevice
The standard of care titanium plates and screws will be used to re-adhere the cranial flap following a craniotomy.
| Study group | Role | What they receive |
|---|---|---|
| TETRANITE Bone Adhesive | Experimental | These participants will receive tetranite to re-adhere the cranial flap following a craniotomy. Receives: Combination Product: Tetranite for Cranial Flap Fixation |
| Standard of Care Plating System | Active comparator | These participants will receive the standard of care plating system to re-adhere the cranial flap following a craniotomy. Receives: Device: Standard of Care Plating System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flap immobility at final surgical fixation (patient)
Immobility of the flap prior to surgical closure, assessed by the principal investigator and an independent neurosurgeon.
Measured: At enrollment surgery
Flap immobility at 6 months (surgeon)
Flap immobility assessed through a flap mobility assessment by the principal investigator and an independent neurosurgeon.
Measured: 6 months after index surgery
No incidence of serious adverse events, including unplanned retreatment of the original surgical site, adjudicated by the CEC to be device-related within 6 months of index surgery.
No incidence of serious adverse events, including unplanned retreatment of the original surgical site, adjudicated by the CEC to be device-related within 6 months of index surgery.
Measured: 6 months from enrollment
Secondary outcomes (11)
Flap immobility through 12 months (patient)
Flap immobility assessed by the patient through a survey.
Measured: 12 months
Serious adverse events, including unplanned retreatment of the original surgical site, adjudicated by the CEC to be device-related beyond 6 months of index surgery.
Serious adverse events, including unplanned retreatment of the original surgical site, adjudicated by the CEC to be device-related beyond 6 months of index surgery.
Measured: 6 months from enrollment to 12 months
Adverse events, including CSF leaks or wound dehiscence
Adverse events, including CSF leaks or wound dehiscence
Measured: From enrollment through 12 months after index surgery.
Patient reported outcome using PROMIS10
Survey sent to the patient to complete independently.
Measured: Enrollment through 12 months from index surgery.
Patient reported outcome using VAS Pain Score
Survey sent to the patient to complete independently.
Measured: Enrollment through 12 months from index surgery
Patient reported outcome using Cranio-Facial PROMS
Survey sent to the patient to complete independently.
Measured: Enrollment through 12 months from index surgery
Flap volume change to assess growth/atrophy based on CT at 6 and 12 Months
Flap volume change to assess growth/atrophy based on CT at 6 and 12 Months
Measured: 6 months and 12 months
Flap fusion to assess bony bridging of the kerf and burr holes via kerf and burr hole gap volume increase/decrease based on CT at 6 and 12 Months
Flap fusion to assess bony bridging of the kerf and burr holes via kerf and burr hole gap volume increase/decrease based on CT at 6 and 12 Months
Measured: 6 months and 12 months
Flap congruence to assess immediate post-operative conformance to surrounding bone
Flap congruence to assess immediate post-operative conformance to surrounding bone
Measured: 1-4 days from index surgery (+7/-3)
Flap displacement to assess migration via peak displacement of the flap surface based on CT at 6 and 12 Months compared to post-operative placement
Flap displacement to assess migration via peak displacement of the flap surface based on CT at 6 and 12 Months compared to post-operative placement
Measured: 6 months and 12 months
Artifact assessment of distortion that obscures lesion detection based on available standard of care MRI throughout the 12- month study period
Artifact assessment of distortion that obscures lesion detection based on available standard of care MRI throughout the 12- month study period
Measured: From enrollment through 12 months following index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start15 Apr 2026 (estimated)
- Primary completion15 Jun 2027 (estimated)
- Study completion15 Dec 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 204 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RevBio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07452549
- Sponsor's protocol ID
- DVAL25068
- Status last verified
- Mar 2026
- First submitted
- 24 Feb 2026
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness of TETRANITE Bone Adhesive for Cranial Flap Fixation Compared to Traditional Metal Hardware
- ClinicalTrials.gov ID
- NCT07452549
- Acronym / sponsor ID
- DVAL25068
- Conditions
- Craniotomy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 204 participants (estimated)
- Lead sponsor
- RevBioIndustry (pharma, biotech, devices)
- Study start
- 15 Apr 2026 (estimated)
- Primary completion
- 15 Jun 2027 (estimated)
- Study completion
- 15 Dec 2027 (estimated)
- First posted
- 5 Mar 2026 (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.
The aim of this study is to demonstrate the safety and efficacy of TETRANITE, a bioresorbable bone adhesive, for Cranial Flap Fixation as compared to traditional metal hardware.
Detailed description
This two arm study will assess the safety and efficacy of TETRANITE, a bioresorbable bone adhesive, for Cranial Flap Fixation as compared to traditional metal hardware. The control arm for this study is the standard of care plating system. Participants will be randomly assigned to either the TETRANITE arm, or the standard of care plating system arm. Participants will generally follow their standard of care follow-up for surgery for one year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TETRANITE Bone Adhesive | Experimental | Combination Product: Tetranite for Cranial Flap FixationThese participants will receive tetranite to re-adhere the cranial flap following a craniotomy. |
| Standard of Care Plating System | Active comparator | Device: Standard of Care Plating SystemThese participants will receive the standard of care plating system to re-adhere the cranial flap following a craniotomy. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subject, and/or subject's family are able and willing to provide informed consent and HIPAA authorization prior to any study related procedures.
- Width of craniotomy kerf line < 3mm for more than 75% of the bone flap border.
Key exclusion criteria (11 listed)
- Subject has undergone a previous, open intracranial neurosurgical procedure in the same anatomical location. (Note: stereotactic biopsy is not exclusionary).
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 FixationTetranite for Cranial Flap Fixation is a bioresorbable bone adhesive that can be used to re-adhere the cranial flap following a craniotomy. | Combination product | TETRANITE Bone Adhesive |
| Standard of Care Plating SystemThe standard of care titanium plates and screws will be used to re-adhere the cranial flap following a craniotomy. | Device | Standard of Care Plating System |
Primary outcome
Flap immobility at final surgical fixation (patient)
Time frame: At enrollment surgery
Immobility of the flap prior to surgical closure, assessed by the principal investigator and an independent neurosurgeon.
Flap immobility at 6 months (surgeon)
Time frame: 6 months after index surgery
Flap immobility assessed through a flap mobility assessment by the principal investigator and an independent neurosurgeon.
No incidence of serious adverse events, including unplanned retreatment of the original surgical site, adjudicated by the CEC to be device-related within 6 months of index surgery.
Time frame: 6 months from enrollment
No incidence of serious adverse events, including unplanned retreatment of the original surgical site, adjudicated by the CEC to be device-related within 6 months of index surgery.
11 secondary outcomes
Flap immobility through 12 months (patient)
Time frame: 12 months
Serious adverse events, including unplanned retreatment of the original surgical site, adjudicated by the CEC to be device-related beyond 6 months of index surgery.
Time frame: 6 months from enrollment to 12 months
Adverse events, including CSF leaks or wound dehiscence
Time frame: From enrollment through 12 months after index surgery.
Patient reported outcome using PROMIS10
Time frame: Enrollment through 12 months from index surgery.
Patient reported outcome using VAS Pain Score
Time frame: Enrollment through 12 months from index surgery
Patient reported outcome using Cranio-Facial PROMS
Time frame: Enrollment through 12 months from index surgery
Flap volume change to assess growth/atrophy based on CT at 6 and 12 Months
Time frame: 6 months and 12 months
Flap fusion to assess bony bridging of the kerf and burr holes via kerf and burr hole gap volume increase/decrease based on CT at 6 and 12 Months
Time frame: 6 months and 12 months
Flap congruence to assess immediate post-operative conformance to surrounding bone
Time frame: 1-4 days from index surgery (+7/-3)
Flap displacement to assess migration via peak displacement of the flap surface based on CT at 6 and 12 Months compared to post-operative placement
Time frame: 6 months and 12 months
Artifact assessment of distortion that obscures lesion detection based on available standard of care MRI throughout the 12- month study period
Time frame: From enrollment through 12 months following index procedure
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 5 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Tetranite for Cranial Flap Fixation in people with Craniotomy, run by RevBio.
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: opening soon, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Gracie Cleaver (862-202-3109, gcleaver@revbio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Flap immobility at final surgical fixation (patient) (time frame: At enrollment surgery). The study lists 3 primary outcomes in all. 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 5 Mar 2026.