<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01712087</url>
  </required_header>
  <id_info>
    <org_study_id>NM-PMK-1001</org_study_id>
    <nct_id>NCT01712087</nct_id>
  </id_info>
  <brief_title>Long-term Surveillance of the MedStream Programmable Infusion System</brief_title>
  <official_title>Long-term Surveillance of the MedStream Programmable Infusion System for the Intrathecal Infusion of Baclofen in the Treatment of Spasticity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Codman &amp; Shurtleff</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Codman &amp; Shurtleff</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This post-approval study will primarily evaluate the long-term safety of the MedStream&#xD;
      Programmable Infusion System when used in combination with Baclofen for the treatment of&#xD;
      severe spasticity. A secondary objective, to assess long-term effectiveness, based on the&#xD;
      observed scores on the Ashworth Scale (rigidity for the lower extremities) and their Spasm&#xD;
      Scores over the 36-month follow-up period will also be described.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Lack of enrollment&#xD;
  </why_stopped>
  <start_date type="Actual">October 1, 2012</start_date>
  <completion_date type="Actual">December 17, 2017</completion_date>
  <primary_completion_date type="Actual">December 17, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The primary endpoint is the incidence of MedStream system-related Adverse Events (AE)</measure>
    <time_frame>24 Months</time_frame>
    <description>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</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>MedStream system-related AEs occurring from 24 to 36 months</measure>
    <time_frame>36 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Device-related AEs occurring with both MedStream and non-MedStream devices used or implanted during the course of the study.</measure>
    <time_frame>24 Months</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedure-related AEs</measure>
    <time_frame>24 Months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Drug-related AEs associated with intrathecal Baclofen</measure>
    <time_frame>24 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Drug-related AEs associated with other intrathecally-administered medications</measure>
    <time_frame>24 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease-related AEs associated with pre-existing conditions</measure>
    <time_frame>24 Months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serious Adverse Events (SAEs)</measure>
    <time_frame>36 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Unanticipated Adverse Device Effects (UADEs)</measure>
    <time_frame>24 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The secondary effectiveness endpoints will be long-term effectiveness of MedStream System</measure>
    <time_frame>24 Month</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">2</enrollment>
  <condition>Spasticity</condition>
  <arm_group>
    <arm_group_label>MedStream System Implants</arm_group_label>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MedStream Programmable Infusion System</intervention_name>
    <description>Intrathecal Infusion of Baclofen in the Treatment of Spasticity</description>
    <arm_group_label>MedStream System Implants</arm_group_label>
    <other_name>MedStream</other_name>
    <other_name>MedStream Pump</other_name>
    <other_name>MedStream programmable pump</other_name>
    <other_name>MedStream Intrathecal Infusion System</other_name>
    <other_name>MedStream Infusion system</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All subjects presenting for a de novo programmable pump implant or replacement of an&#xD;
        implantable, programmable infusion pump for the treatment of severe spasticity with&#xD;
        intrathecal Baclofen are potential study candidates and will be screened for study&#xD;
        eligibility. Subjects who do not meet all inclusion/exclusion criteria will not be enrolled&#xD;
        into this study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The subject is a viable candidate for &quot;de novo&quot; or continued (pump replacement)&#xD;
             therapy for the treatment of severe spasticity with intrathecal Baclofen delivered by&#xD;
             an implantable programmable pump.&#xD;
&#xD;
          -  The subject or his/her Legally Authorized Representative must voluntarily provide&#xD;
             Informed Consent for participation in this study in accordance with 21 Code of Federal&#xD;
             Regulations (CFR) Part 50.&#xD;
&#xD;
          -  The subject is willing to comply with the protocol-specified follow-up visit&#xD;
             requirements for a period of 36 months after implant.&#xD;
&#xD;
          -  The subject has an anticipated life expectancy of 24 months or greater.&#xD;
&#xD;
          -  The subject must be 18 years of age or older at time of MedStream implant procedure.&#xD;
&#xD;
          -  The subject is of sufficient body size to accommodate pump placement, in the opinion&#xD;
             of the Investigator.&#xD;
&#xD;
          -  The subject will receive a de novo or replacement implant of the MedStream 20 mL or 40&#xD;
             mL pump, MedStream approved catheter(s) and MedStream accessories.&#xD;
&#xD;
          -  The Investigator intends to use Baclofen in the pump for treatment of severe&#xD;
             spasticity&#xD;
&#xD;
          -  The subject is capable of self-reporting spasm frequency.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Concurrent enrollment in an investigational device or drug study that has not&#xD;
             completed the required follow-up period.&#xD;
&#xD;
          -  Subject has had an infection and/or inflammation at or near the pump and/or catheter&#xD;
             implantation site(s) within 30 days preceding enrollment.&#xD;
&#xD;
          -  Evidence of a fever or infection within 10 days prior to the surgical implant&#xD;
             procedure that, in the opinion of the Investigator might impact a successful pump&#xD;
             implant.&#xD;
&#xD;
          -  The subject has known hypersensitivity/allergies or contraindication to Baclofen or&#xD;
             the materials in the infusion pump or catheter(s).&#xD;
&#xD;
          -  The subject has a co-morbid condition that could limit his/her ability to participate&#xD;
             in the study or to comply with the follow-up requirements or, which might impact the&#xD;
             scientific integrity of the study.&#xD;
&#xD;
          -  The subject has a rapid degenerative neurological disease such as lateral sclerosis,&#xD;
             amyotrophic lateral sclerosis (ALS), rapidly progressive Multiple Sclerosis, inherited&#xD;
             or rapidly progressive leukodystrophies, Moyamoya disease, cerebral autosomal dominant&#xD;
             arteriopathy with subcortical infarcts and leucoencephalopathy (CADASIL),&#xD;
             thrombophilias, rapidly progressive autoimmune disorders, or any disorder where&#xD;
             progression of the underlying spinal cord or a central nervous system (CNS) disease is&#xD;
             expected to progress significantly over the next 3 years&#xD;
&#xD;
          -  Subject is a prisoner.&#xD;
&#xD;
          -  Subject was previously enrolled in this study.&#xD;
&#xD;
          -  Subject is pregnant or breastfeeding. (Note: females of child bearing potential must&#xD;
             have a negative pregnancy test prior to enrollment in the study).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jonathan T Megerian, MD</last_name>
    <role>Study Director</role>
    <affiliation>Codman &amp; Shurtleff</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UMass Memorial Medical Center</name>
      <address>
        <city>Worcester</city>
        <state>Massachusetts</state>
        <zip>01655</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Methodist Hospital Research Institute</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>October 19, 2012</study_first_submitted>
  <study_first_submitted_qc>October 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 23, 2012</study_first_posted>
  <last_update_submitted>January 21, 2019</last_update_submitted>
  <last_update_submitted_qc>January 21, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>spasticity</keyword>
  <keyword>muscle spasticity</keyword>
  <keyword>muscle rigidity</keyword>
  <keyword>motor neuron disease</keyword>
  <keyword>hyperreflexia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Muscle Spasticity</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01712087
org study id: NM-PMK-1001
nct id: NCT01712087
lead sponsor: 
has dmc: Yes
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.
observational model: Case-Control
time perspective: Prospective
measure: The primary endpoint is the incidence of MedStream system-related Adverse Events (AE)
time frame: 24 Months
description: 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
measure: MedStream system-related AEs occurring from 24 to 36 months
time frame: 36 Months
measure: Device-related AEs occurring with both MedStream and non-MedStream devices used or implanted during the course of the study.
time frame: 24 Months
description: 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
measure: Procedure-related AEs
time frame: 24 Months
description: 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.
measure: Drug-related AEs associated with intrathecal Baclofen
time frame: 24 Months
measure: Drug-related AEs associated with other intrathecally-administered medications
time frame: 24 Months
measure: Disease-related AEs associated with pre-existing conditions
time frame: 24 Months
description: 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.
measure: Serious Adverse Events (SAEs)
time frame: 36 Months
measure: Unanticipated Adverse Device Effects (UADEs)
time frame: 24 Months
measure: The secondary effectiveness endpoints will be long-term effectiveness of MedStream System
time frame: 24 Month
description: 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.
arm group label: MedStream System Implants
description: 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.
intervention type: Device
intervention name: MedStream Programmable Infusion System
description: Intrathecal Infusion of Baclofen in the Treatment of Spasticity
arm group label: MedStream System Implants
other name: MedStream
other name: MedStream Pump
other name: MedStream programmable pump
other name: MedStream Intrathecal Infusion System
other name: MedStream Infusion system
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jonathan T Megerian, MD
role: Study Director
affiliation: Codman & Shurtleff
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Muscle Spasticity