Long-term Surveillance of the MedStream Programmable Infusion System

January 21, 2019 updated by: Codman & Shurtleff

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The primary endpoint is the incidence of MedStream system-related Adverse Events (AE)
Time Frame: 24 Months
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
MedStream system-related AEs occurring from 24 to 36 months
Time Frame: 36 Months
36 Months
Device-related AEs occurring with both MedStream and non-MedStream devices used or implanted during the course of the study.
Time Frame: 24 Months
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
Time Frame: 24 Months
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
Time Frame: 24 Months
24 Months
Drug-related AEs associated with other intrathecally-administered medications
Time Frame: 24 Months
24 Months
Disease-related AEs associated with pre-existing conditions
Time Frame: 24 Months
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)
Time Frame: 36 Months
36 Months
Unanticipated Adverse Device Effects (UADEs)
Time Frame: 24 Months
24 Months
The secondary effectiveness endpoints will be long-term effectiveness of MedStream System
Time Frame: 24 Month
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Codman & Shurtleff

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Jonathan T Megerian, MD, Codman & Shurtleff

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2012

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 17, 2017

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 17, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 19, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 22, 2012

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 23, 2012

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 23, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NM-PMK-1001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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