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Safety and Performance of the ThecaFlex DRx™ System Port and Catheter for Chronic Intrathecal Access, Cerebrospinal Fluid (CSF) Aspiration, and DElivery of Nusinersen in Spinal Muscular Atrophy (SMA) Patients Resistant to Lumbar PunctuRE Trial (PIERRE)
Conditions
Interventions
ThecaFlex DRx System
Locations
21
United States
Barrow Neurological Institute
Phoenix, Arizona, United States
Children's Hospital Orange County
Orange, California, United States
Stanford Medical Center
Palo Alto, California, United States
Rady Children's Hospital
San Diego, California, United States
Nemours Children's Hospital, Florida
Orlando, Florida, United States
Lurie Childrens Hospital
Chicago, Illinois, United States
Start Date
November 27, 2023
Primary Completion Date
April 1, 2028
Completion Date
July 1, 2030
Last Updated
April 16, 2026
NCT06839469
NCT06365892
NCT04761549
NCT06314594
NCT04885244
NCT06298812
Lead Sponsor
Alcyone Therapeutics, Inc
Collaborators
Data Source & Attribution
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