New implant could help SMA patients who Can't get spinal injections
NCT ID NCT05866419
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This trial tests a new implantable device called ThecaFlex DRx in 90 people with spinal muscular atrophy (SMA) who cannot receive standard spinal injections due to spine problems or other risks. The device is placed under the skin and delivers the medication nusinersen directly into the spinal fluid. Researchers will check if the device works safely and effectively over 12 months.
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
Active substance
ThecaFlex DRx System (implantable port and catheter)
What this could lead to
If successful, this device could provide a safer, easier way to deliver life-saving SMA medication to patients who currently cannot receive it due to spine problems.
What could go wrong
This is an early feasibility study with no control group, so results may not confirm the device is better than standard care. Implant surgery carries risks like infection or device malfunction.
Disclaimer
Read more
Show less
This is a summary of
the original study
.
Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for SPINAL MUSCULAR ATROPHY are added.
By submitting, you agree to our Terms of use
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Show contact details
Enter your email to view the contact information for this study.
By submitting, you agree to our Terms of use
Study contacts
-
Contact
Phone: •••-•••-•••• Email: •••••@•••••
Locations
-
Barrow Neurological Institute
RECRUITINGPhoenix, Arizona, 85013, United States
Contact Phone: •••-•••-•••• Email: •••••@•••••
Contact
-
Boston Children's Hospital
RECRUITINGBoston, Massachusetts, 02115, United States
Contact Email: •••••@•••••
-
Children's Hospital Orange County
RECRUITINGOrange, California, 92868, United States
Contact Email: •••••@•••••
-
Children's Hospital Philadelphia
RECRUITINGPhiladelphia, Pennsylvania, 19104, United States
Contact Email: •••••@•••••
-
Childrens Hospital of the King's Daughters
RECRUITINGNorfolk, Virginia, 23510, United States
Contact Email: •••••@•••••
-
Columbia University Irving Medical Center/NewYork Presbyterian Hospital
RECRUITINGNew York, New York, 10032, United States
Contact Phone: •••-•••-•••• Email: •••••@•••••
-
Helen DeVos Children's Hospital
RECRUITINGGrand Rapids, Michigan, 49503, United States
Contact Email: •••••@•••••
-
Hospital Universitario La Paz
RECRUITINGMadrid, Spain
Contact Email: •••••@•••••
-
Hospital Universitario y Politecnico la Fe de Valencia
RECRUITINGValencia, 46026, Spain
Contact Email: •••••@•••••
-
Lurie Childrens Hospital
RECRUITINGChicago, Illinois, 60611, United States
Contact Email: •••••@•••••
Contact
-
Nemours Children's Hospital, Florida
RECRUITINGOrlando, Florida, 32827, United States
Contact Email: •••••@•••••
-
Penn State Milton S. Hershey Medical Center
RECRUITINGHershey, Pennsylvania, 17033, United States
Contact Email: •••••@•••••
-
Rady Children's Hospital
RECRUITINGSan Diego, California, 92037, United States
Contact Email: •••••@•••••
-
Research Institute of Polish Mother's Memorial Hospital
RECRUITINGLodz, Poland
Contact Email: •••••@•••••
-
Sheffield Teaching Hospitals NHS Foundation Trust
RECRUITINGSheffield, United Kingdom
Contact Email: •••••@•••••
-
Specialised Hospital Ludwika Rydygiera
RECRUITINGKrakow, Poland
Contact Email: •••••@•••••
-
Stanford Medical Center
RECRUITINGPalo Alto, California, 94301, United States
Contact Email: •••••@•••••
-
Texas Children's Hospital
RECRUITINGHouston, Texas, 77030, United States
Contact Email: •••••@•••••
-
UH Rainbow Babies and Children's Hospital
RECRUITINGCleveland, Ohio, 44106, United States
Contact Email: •••••@•••••
-
University of Virginia
RECRUITINGCharlottesville, Virginia, 22903, United States
Contact Email: •••••@•••••
Contact
-
Universitätsklinikum Essen
RECRUITINGEssen, Germany
Contact Email: •••••@•••••