Cranial BoneNCT07103330
Evaluation of Cranial Flap Fixation With Montage Flowable Settable Bone Paste
A study testing Metallic fixation hardware and Cranial flap placement and fixation using only Montage Flowable Settable Bone Paste in people with Cranial Bone and Post-operative Complications, run by Abyrx, Inc..
Trial summary
Montage Flowable Settable Bone Paste is a self-setting calcium phosphate cement indicated for use in the repair of neurosurgical burr holes, contiguous craniotomy cuts and other cranial defects with a surface area no larger than 25cm2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cranial Bone, Post-operative Complications, Cranial Fixation
- What is being tested?
- Metallic fixation hardware and Cranial flap placement and fixation using only Montage Flowable Settable Bone Paste
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Mar 2026to 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female > 18 years of age
- Undergoing a cranial procedure in supratentorial location
- Width of craniotomy kerf line <3mm for 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.
- 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 Montage Flowable 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
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Montage Flowable Settable Bone Paste is a self-setting calcium phosphate cement indicated for use in the repair of neurosurgical burr holes, contiguous craniotomy cuts and other cranial defects with a surface area no larger than 25cm2. It is also intended to be used for the fixation of cranial bone flaps following craniotomy. The MONTAGE Flowable device comprises two separate components of paste-like consistency containing granular calcium phosphate, calcium stearate, vitamin E acetate, a triglyceride, polyalcohols and a mixture of a lactide-diester and polyester-based polymers. When mixed together in the applicator tip, the components of the MONTAGE Flowable device form a cohesive paste-like material that adheres to the bone surface and remains in place following application. The resulting hardened, resorbable material is primarily calcium phosphate. The components must be mixed immediately prior to use.
- Conditions
- Cranial Bone, Post-operative Complications, Cranial Fixation, Cranioplasty, Adhesive Bone Cement
- Being tested
- Metallic fixation hardware, Cranial flap placement and fixation using only Montage Flowable Settable Bone Paste
- Keywords
- Cranioplasty, Settable bone paste, Adhesive cranial cement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metallic fixation hardwareDevice
Control
Cranial flap placement and fixation using only Montage Flowable Settable Bone PasteDevice
Experimental
| Study group | Role | What they receive |
|---|---|---|
| Montage Flowable Settable Bone Paste | Experimental | Fixation using Montage Flowable Settable Bone Paste exclusively Receives: Device: Cranial flap placement and fixation using only Montage Flowable Settable Bone Paste |
| Control | Active comparator | Metallic fixation hardware Receives: Device: Metallic fixation hardware |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cranial flap immobility
Cranial flap immobility as determine by the neurosurgeon will be tabulated and compared between group
Measured: 12 months
Secondary outcomes (2)
Flap localization
Localization of the flap based on CT scan compared between groups.
Measured: 12 months
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: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2025
- Study startMar 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cranial BoneStudies 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
- Model description
- Post-market, Prospective, Randomized, Multi Center, Single Blind (Patient)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abyrx, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07103330
- Sponsor's protocol ID
- Abyrx PMRCT 25-001
- Status last verified
- Jul 2025
- First submitted
- 29 Jul 2025
- Last updated
- 5 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Cranial Flap Fixation With Montage Flowable Settable Bone Paste
- ClinicalTrials.gov ID
- NCT07103330
- Acronym / sponsor ID
- Abyrx PMRCT 25-001
- Conditions
- Cranial Bone, Post-operative Complications, Cranial Fixation, Cranioplasty, Adhesive Bone Cement
- Keywords
- Cranioplasty, Settable bone paste, Adhesive cranial cement
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Abyrx, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 5 Aug 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.
Montage Flowable Settable Bone Paste is a self-setting calcium phosphate cement indicated for use in the repair of neurosurgical burr holes, contiguous craniotomy cuts and other cranial defects with a surface area no larger than 25cm2. It is also intended to be used for the fixation of cranial bone flaps following craniotomy. The MONTAGE Flowable device comprises two separate components of paste-like consistency containing granular calcium phosphate, calcium stearate, vitamin E acetate, a triglyceride, polyalcohols and a mixture of a lactide-diester and polyester-based polymers. When mixed together in the applicator tip, the components of the MONTAGE Flowable device form a cohesive paste-like material that adheres to the bone surface and remains in place following application. The resulting hardened, resorbable material is primarily calcium phosphate. The components must be mixed immediately prior to use.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Post-market, Prospective, Randomized, Multi Center, Single Blind (Patient)
| Arm | Type | Receives |
|---|---|---|
| Montage Flowable Settable Bone Paste | Experimental | Device: Cranial flap placement and fixation using only Montage Flowable Settable Bone PasteFixation using Montage Flowable Settable Bone Paste exclusively |
| Control | Active comparator | Device: Metallic fixation hardwareMetallic fixation hardware |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female > 18 years of age
- Undergoing a cranial procedure in supratentorial location
- Width of craniotomy kerf line <3mm for than 75% of the bone flap border
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.
- 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 |
|---|---|---|
| Metallic fixation hardwareControl | Device | Control |
| Cranial flap placement and fixation using only Montage Flowable Settable Bone PasteExperimental | Device | Montage Flowable Settable Bone Paste |
Primary outcome
Cranial flap immobility
Time frame: 12 months
Cranial flap immobility as determine by the neurosurgeon will be tabulated and compared between group
2 secondary outcomes
Flap localization
Time frame: 12 months
Device-related adverse events
Time frame: 12 months
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 Aug 2025.
- 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 Metallic fixation hardware and Cranial flap placement and fixation using only Montage Flowable Settable Bone Paste in people with Cranial Bone and Post-operative Complications, run by Abyrx, Inc..
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 3 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 Aug 2025. 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 Aniq Darr, Ph.D. (18554759175, Darr@Abyrx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cranial flap immobility (time frame: 12 months). 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 Aug 2025.