Long-term Surveillance of the MedStream Programmable Infusion System

Long-term Surveillance of the MedStream Programmable Infusion System for the Intrathecal Infusion of Baclofen in the Treatment of Spasticity

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.

Study Overview

• Status: Terminated
• Conditions: Spasticity
• Intervention / Treatment: Device: MedStream Programmable Infusion System

• Study Type: Observational
• Enrollment (Actual): 2

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Worcester, Massachusetts, United States, 01655
      • UMass Memorial Medical Center
  • Texas
    • Houston, Texas, United States, 77030
      • Methodist Hospital Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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).

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
MedStream System Implants; 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.	Device: MedStream Programmable Infusion System; Intrathecal Infusion of Baclofen in the Treatment of Spasticity; Other Names: MedStream; MedStream Pump; MedStream programmable pump; MedStream Intrathecal Infusion System; MedStream Infusion system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The primary endpoint is the incidence of MedStream system-related Adverse Events (AE)	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	24 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MedStream system-related AEs occurring from 24 to 36 months		36 Months
Device-related AEs occurring with both MedStream and non-MedStream devices used or implanted during the course of the study.	Device-related AEs occurring in subjects with both MedStream and non-MedStream devices used or implanted during the course of the study. Device refers to the pump and intrathecal catheters	24 Months
Procedure-related AEs	Procedure-related AEs including, but not limited to the following study procedures: MedStream system implant, pump refill and bolus, and reprogramming. If non-MedStream devices or components are utilized in these procedures, this will be described.	24 Months
Drug-related AEs associated with intrathecal Baclofen		24 Months
Drug-related AEs associated with other intrathecally-administered medications		24 Months
Disease-related AEs associated with pre-existing conditions	Disease-related AEs associated with pre-existing conditions that demonstrate a significant worsening of the disease or an increase in the frequency of episodes since baseline, as determined by the investigator.	24 Months
Serious Adverse Events (SAEs)		36 Months
Unanticipated Adverse Device Effects (UADEs)		24 Months
The secondary effectiveness endpoints will be long-term effectiveness of MedStream System	Long-term effectiveness as demonstrated by scores on the Ashworth Scale (lower extremity) and the frequency and severity components of the Penn Spasm Frequency Scale (PSFS) measured pre-implant, post-implant and at each of the protocol-specified study visits.	24 Month

Collaborators and Investigators

• Sponsor: Codman & Shurtleff
• Investigators: Study Director: Jonathan T Megerian, MD, Codman & Shurtleff

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2012
• Primary Completion (ACTUAL): December 17, 2017
• Study Completion (ACTUAL): December 17, 2017

Study Registration Dates

• First Submitted: October 19, 2012
• First Submitted That Met QC Criteria: October 22, 2012
• First Posted (ESTIMATE): October 23, 2012

Study Record Updates

• Last Update Posted (ACTUAL): January 23, 2019
• Last Update Submitted That Met QC Criteria: January 21, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: spasticity; motor neuron disease; muscle spasticity; muscle rigidity; hyperreflexia
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Neuromuscular Manifestations; Muscle Hypertonia; Muscle Spasticity
• Other Study ID Numbers: NM-PMK-1001