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Clinical Trial

Study of an Intrathecal Port and Catheter System for Subjects With Spinal Muscular Atrophy

NCT: NCT05866419 · RECRUITING

NCT IDNCT05866419
StatusRECRUITING
Start Date2023-11-27
Completion2030-07

Brief Summary

The primary objective of the clinical investigation is to demonstrate successful clinical use of the ThecaFlex DRx™ System in delivering nusinersen in subjects with spinal muscular atrophy (SMA). All enrolled subjects will undergo implantation of the investigational device (ThecaFlex DRx™ System) and will be followed for 12 months after receiving the implant. The 12-month data will be used to assess the primary endpoint support a Pre-Market Approval (PMA) application.

Frequently Asked Questions

What is Study of an Intrathecal Port and Catheter System for Subjects With Spinal Muscular Atrophy?

Study of an Intrathecal Port and Catheter System for Subjects With Spinal Muscular Atrophy is a clinical trial registered under NCT05866419. Current status: RECRUITING.

What is the status of NCT05866419?

The current status of NCT05866419 (Study of an Intrathecal Port and Catheter System for Subjects With Spinal Muscular Atrophy) is: RECRUITING.

When did Study of an Intrathecal Port and Catheter System for Subjects With Spinal Muscular Atrophy start?

Study of an Intrathecal Port and Catheter System for Subjects With Spinal Muscular Atrophy started on 2023-11-27.

Official Source

View on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.

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