Long-term Surveillance of the MedStream Programmable Infusion System

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Codman & Shurtleff
Sponsor:
Information provided by (Responsible Party):
Codman & Shurtleff
ClinicalTrials.gov Identifier:
NCT01712087
First received: October 19, 2012
Last updated: April 11, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Spasticity
Device: MedStream Programmable Infusion System

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Long-term Surveillance of the MedStream Programmable Infusion System for the Intrathecal Infusion of Baclofen in the Treatment of Spasticity

Resource links provided by NLM:


Further study details as provided by Codman & Shurtleff:

Primary Outcome Measures:
  • The primary endpoint is the incidence of MedStream system-related Adverse Events (AE) [ Time Frame: 24 Months ] [ Designated as safety issue: Yes ]
    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


Secondary Outcome Measures:
  • MedStream system-related AEs occurring from 24 to 36 months [ Time Frame: 36 Months ] [ Designated as safety issue: Yes ]
  • Device-related AEs occurring with both MedStream and non-MedStream devices used or implanted during the course of the study. [ Time Frame: 24 Months ] [ Designated as safety issue: Yes ]
    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

  • Procedure-related AEs [ Time Frame: 24 Months ] [ Designated as safety issue: Yes ]
    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.

  • Drug-related AEs associated with intrathecal Baclofen [ Time Frame: 24 Months ] [ Designated as safety issue: Yes ]
  • Drug-related AEs associated with other intrathecally-administered medications [ Time Frame: 24 Months ] [ Designated as safety issue: Yes ]
  • Disease-related AEs associated with pre-existing conditions [ Time Frame: 24 Months ] [ Designated as safety issue: Yes ]
    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.

  • Serious Adverse Events (SAEs) [ Time Frame: 36 Months ] [ Designated as safety issue: Yes ]
  • Unanticipated Adverse Device Effects (UADEs) [ Time Frame: 24 Months ] [ Designated as safety issue: Yes ]
  • The secondary effectiveness endpoints will be long-term effectiveness of MedStream System [ Time Frame: 24 Month ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 212
Study Start Date: October 2012
Estimated Study Completion Date: July 2020
Estimated Primary Completion Date: February 2020 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01712087

Contacts
Contact: Jandira Ramos, MPH 508.828.3127 jramos8@its.jnj.com
Contact: Jonathan Megerian, MD 508.880.8274

Locations
United States, Massachusetts
UMass Memorial Medical Center Recruiting
Worcester, Massachusetts, United States, 01655
United States, Texas
Methodist Hospital Research Institute Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
Codman & Shurtleff
Investigators
Study Director: Jonathan T Megerian, MD Codman & Shurtleff
  More Information

No publications provided

Responsible Party: Codman & Shurtleff
ClinicalTrials.gov Identifier: NCT01712087     History of Changes
Other Study ID Numbers: NM-PMK-1001
Study First Received: October 19, 2012
Last Updated: April 11, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Codman & Shurtleff:
spasticity
muscle spasticity
muscle rigidity
motor neuron disease
hyperreflexia

Additional relevant MeSH terms:
Muscle Spasticity
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 30, 2014