90
Participants
Start Date
November 27, 2023
Primary Completion Date
May 31, 2026
Study Completion Date
March 31, 2027
ThecaFlex DRx System
The ThecaFlex DRx™ System consists of an implantable intrathecal catheter, and an implantable subcutaneous port, designed specifically to meet the implantation, Cerebrospinal Fluid (CSF) aspiration, and intrathecal delivery and dosing needs of patients (aged ≥ 3 years) requiring repeated/on-going intermittent chronic bolus intrathecal treatment for life threatening, debilitating Central Nervous System (CNS) disorders who are precluded from Lumbar Puncture (LP) due to complex spine conditions, or who are resistant to LP for therapy administration or CSF aspiration.
NOT_YET_RECRUITING
Columbia University Irving Medical Center/NewYork Presbyterian Hospital, New York
RECRUITING
Penn State Milton S. Hershey Medical Center, Hershey
RECRUITING
Children's Hospital Philadelphia, Philadelphia
RECRUITING
Centro Clinico Nemo, Milan
RECRUITING
University of Virginia, Charlottesville
RECRUITING
Childrens Hospital of the King's Daughters, Norfolk
RECRUITING
UH Rainbow Babies and Children's Hospital, Cleveland
RECRUITING
Hospital Universitario y Politecnico la Fe de Valencia, Valencia
RECRUITING
Helen DeVos Children's Hospital, Grand Rapids
RECRUITING
Lurie Childrens Hospital, Chicago
RECRUITING
Texas Children's Hospital, Houston
RECRUITING
Barrow Neurological Institute, Phoenix
RECRUITING
Rady Children's Hospital, San Diego
RECRUITING
Children's Hospital Orange County, Orange
RECRUITING
Stanford Medical Center, Palo Alto
RECRUITING
Boston Children's Hospital, Boston
RECRUITING
Universitätsklinikum Essen, Essen
RECRUITING
Specialised Hospital Ludwika Rydygiera, Krakow
RECRUITING
Research Institute of Polish Mother's Memorial Hospital, Lodz
RECRUITING
Hospital Universitario La Paz, Madrid
Lead Sponsor
Collaborators (1)
Biogen
INDUSTRY
Alcyone Therapeutics, Inc
INDUSTRY