Rdzeniowy zanik mięśni: badanie kliniczne

Kryteria wyłączenia kto nie może wziąć udziału (22)

1. Subject meets any of the contraindications for use of the ThecaFlex DRx System as outlined in the ThecaFlex DRx System Instructions for Use
2. Presence or history of (< 6 months prior to the procedure): an implanted microinfusion pump, intrathecal catheter, or other intrathecal drug delivery devices/component, or implanted shunt for drainage of cerebrospinal fluid (CSF), or reservoir in the CSF space (note: any ThecaFlex Port and Catheter System must not be placed in the same location as a previous indwelling port and catheter)
3. Subject is pregnant or nursing or plans to become pregnant during the course of the clinical investigation, or is a woman of childbearing potential or a man of reproductive age who is unwilling or unable to practice contraception, as described in Section 14.10.
4. Any condition or event, which in the opinion of the Investigator may adversely affect the safety and effective implantation and use of the ThecaFlex DRx system or confound the clinical investigation, including:
5. Severe structural impediment that may preclude safe implantation of the catheter and port
6. Major medical events (as defined per investigator's discretion) within 60 days prior to screening; or
7. Relevant surgeries (e.g., head and neck, back, etc.) within 60 days prior to screening or planned during the duration of the clinical investigation
8. Space-occupying lesion with mass effect
9. Posterior fossa mass
10. Arnold-Chiari malformation
11. Coagulation abnormalities and/or thrombocytopenia
12. Insufficient or inadequate skin or underlying fat to adequately protect the port or enough surface area to allow the skin to close safely
13. Subject is contraindicated for administration of nusinersen per its approved country-specific labeling
14. History of intrathecal granuloma formation
15. History of bacterial meningitis or aseptic meningitis within 6 months of screening
16. History of tumors or other spinal abnormalities documented by magnetic resonance imaging (MRI) or computed tomography (CT) that would interfere with the catheter implantation procedures or CSF circulation
17. History of hydrocephalus
18. Diagnosed degenerative muscular disease other than SMA
19. History of depression, cognitive impairment, or another psycho-behavioral problem that in the opinion of the Investigator may preclude safe participation in the clinical investigation and
20. Serious medical condition that, in the opinion of the investigator, may lead to reduced life expectancy beyond 12 months.
21. Subject is involved in another Investigation Device Exemption Study.
22. Subject has clinically meaningful immunosuppression, in the opinion of the investigator, either from therapy or a comorbid condition, which, in the opinion of the investigator, makes them a poor surgical candidate due to increased risk of infection.