A phase Ib study to investigate the safety and effect of BR-003
Phase 1
- Conditions
- Patients planned for open or percutaneous posterior spinal stabilisation with 4 or 6 pedicle screws with a diameter of 5 to 7.5 mm (inclusive), with or without concomitant posterolateral fusion, vertebral augmentation, intervertebral body fusion devices, osteotomies, and posterior decompression.Therapeutic area: Analytical,Diagnostic,Therapeutic Techniques and Equipment [E]-Surgical Procedures, Operative [E04]
- Registration Number
- CTIS2024-516338-37-00
- Lead Sponsor
- SentryX B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 12
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: ;Secondary Objective: ;Primary end point(s):
- Secondary Outcome Measures
Name Time Method