Clinical trial NCT01712087: Long-term Surveillance of the MedStream Programmable Infusion System
Official title: Long-term Surveillance of the MedStream Programmable Infusion System for the Intrathecal Infusion of Baclofen in the Treatment of Spasticity
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Spasticity
Keywords: spasticity
muscle spasticity
muscle rigidity
motor neuron disease
hyperreflexia
Lead sponsor: Codman & Shurtleff
Sponsor class: INDUSTRY
First posted: 2012-10-23
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All subjects presenting for a de novo programmable pump implant or replacement of an implantable, programmable infusion pump for the treatment of severe spasticity with intrathecal Baclofen are potential study candidates and will be screened for study eligibility. Subjects who do not meet all inclusion/exclusion criteria will not be enrolled into this study.

Brief 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.


Eligibility criteria: 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 procedure that, in the opinion of the Investigator might impact a successful pump implant.
* The subject has known hypersensitivity/allergies or contraindication to Baclofen or the materials in the infusion pump or catheter(s).
* The subject has a co-morbid condition that could limit his/her ability to participate in the study or to comply with the follow-up requirements or, which might impact the scientific integrity of the study.
* The subject has a rapid degenerative neurological disease such as lateral sclerosis, amyotrophic lateral sclerosis (ALS), rapidly progressive Multiple Sclerosis, inherited or rapidly progressive leukodystrophies, Moyamoya disease, cerebral autosomal dominant arteriopathy with subcortical infarcts and leucoencephalopathy (CADASIL), thrombophilias, rapidly progressive autoimmune disorders, or any disorder where progression of the underlying spinal cord or a central nervous system (CNS) disease is expected to progress significantly over the next 3 years
* Subject is a prisoner.
* Subject was previously enrolled in this study.
* Subject is pregnant or breastfeeding. (Note: females of child bearing potential must have a negative pregnancy test prior to enrollment in the study).

Primary outcomes:
measure: The primary endpoint is the incidence of MedStream system-related Adverse Events (AE)
timeFrame: 24 Months
Secondary outcomes:
measure: MedStream system-related AEs occurring from 24 to 36 months
timeFrame: 36 Months
measure: Device-related AEs occurring with both MedStream and non-MedStream devices used or implanted during the course of the study.
timeFrame: 24 Months
measure: Procedure-related AEs
timeFrame: 24 Months
measure: Drug-related AEs associated with intrathecal Baclofen
timeFrame: 24 Months
measure: Drug-related AEs associated with other intrathecally-administered medications
timeFrame: 24 Months
measure: Disease-related AEs associated with pre-existing conditions
timeFrame: 24 Months
measure: Serious Adverse Events (SAEs)
timeFrame: 36 Months
measure: Unanticipated Adverse Device Effects (UADEs)
timeFrame: 24 Months
measure: The secondary effectiveness endpoints will be long-term effectiveness of MedStream System
timeFrame: 24 Month
Other outcomes:
Locations:
city: Worcester
country: United States
facility: UMass Memorial Medical Center
state: Massachusetts
city: Houston
country: United States
facility: Methodist Hospital Research Institute
state: Texas
Study officials:
affiliation: Codman & Shurtleff
name: Jonathan T Megerian, MD
role: STUDY_DIRECTOR
References: