Long-term Surveillance of the MedStream Programmable Infusion System (NCT01712087) | Clinical Trial Compass
TerminatedNot Applicable
Long-term Surveillance of the MedStream Programmable Infusion System
Stopped: Lack of enrollment
United States2 participantsStarted 2012-10-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* The subject is a viable candidate for "de novo" or continued (pump replacement) therapy for the treatment of severe spasticity with intrathecal Baclofen delivered by an implantable programmable pump.
* The subject or his/her Legally Authorized Representative must voluntarily provide Informed Consent for participation in this study in accordance with 21 Code of Federal Regulations (CFR) Part 50.
* The subject is willing to comply with the protocol-specified follow-up visit requirements for a period of 36 months after implant.
* The subject has an anticipated life expectancy of 24 months or greater.
* The subject must be 18 years of age or older at time of MedStream implant procedure.
* The subject is of sufficient body size to accommodate pump placement, in the opinion of the Investigator.
* The subject will receive a de novo or replacement implant of the MedStream 20 mL or 40 mL pump, MedStream approved catheter(s) and MedStream accessories.
* The Investigator intends to use Baclofen in the pump for treatment of severe spasticity
* The subject is capable of self-reporting spasm frequency.
Exclusion Criteria:
* Concurrent enrollment in an investigational device or drug study that has not completed the required follow-up period.
* Subject has had an infection and/or inflammation at or near the pump and/or catheter implantation site(s) within 30 days preceding enrollment.
* Evidence of a fever or infection within 10 days prior to the surgical implant pro…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The primary endpoint is the incidence of MedStream system-related Adverse Events (AE)