Trials / Not Yet Recruiting
Not Yet RecruitingNCT07103330
Evaluation of Cranial Flap Fixation With Montage Flowable Settable Bone Paste
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- Sponsor
- Abyrx, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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. 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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Metallic fixation hardware | Control |
| DEVICE | Cranial flap placement and fixation using only Montage Flowable Settable Bone Paste | Experimental |
Timeline
- Start date
- 2026-03-01
- Primary completion
- 2027-12-01
- Completion
- 2027-12-01
- First posted
- 2025-08-05
- Last updated
- 2025-08-05
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT07103330. Inclusion in this directory is not an endorsement.