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NCT01712087 · ClinicalTrials.gov registry record
Long-term Surveillance of the MedStream Programmable Infusion System
A clinical trial, sponsored by Codman & Shurtleff.
- Terminated
- Registry status
- 2
- Enrollment target
NCT01712087: Clinical Trial study, sponsored by Codman & Shurtleff.
NCT01712087 is a clinical trial that was terminated before completion, run by Codman & Shurtleff. The registered enrollment target is 2 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01712087 was terminated before completion, sponsored by Codman & Shurtleff.
- TERMINATED
- Registry status
- 2 participants
- Enrollment target
Study Summary
This post-approval study will primarily evaluate the long-term safety of the MedStream Programmable Infusion System when used in combination with Baclofen for the treatment of severe spasticity. A secondary objective, to assess long-term effectiveness, based on the observed scores on the Ashworth Scale (rigidity for the lower extremities) and their Spasm Scores over the 36-month follow-up period will also be described.
Primary Outcome
The primary endpoint is the incidence of MedStream system-related AEs (MedStream pump and catheters) based on Clinical Events Committee determination of relationship, that occur from the start of the MedStream implant procedure (incision) until completion of the 24 month follow-up visit
Interventions
- DEVICE MedStream Programmable Infusion System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2012-10-01 |
| Est. Completion | 2017-12-17 |
Why NCT01712087 stopped before completion
NCT01712087 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 2 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which MedStream Programmable Infusion System is the first listed.
NCT01712087 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01712087 about?
NCT01712087 is a clinical study titled "Long-term Surveillance of the MedStream Programmable Infusion System". This post-approval study will primarily evaluate the long-term safety of the MedStream Programmable Infusion System when used in combination with Baclofen for the treatment of severe spasticity. A secondary objective, to assess long-term effectiveness, based on the observed scores on the Ashworth Sc...
What is the current status of trial NCT01712087?
This trial is currently terminated. The enrollment target is 2 participants. The study started on 2012-10-01. Estimated completion is 2017-12-17.
What interventions are being tested in trial NCT01712087?
The interventions under investigation include: MedStream Programmable Infusion System (DEVICE).
Who is sponsoring clinical trial NCT01712087?
This trial is sponsored by Codman & Shurtleff, which has 6 total clinical trials registered on ClinicalTrials.gov.
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