xml: <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/NCT05964855</url>
    </required_header>
    <id_info>
      <org_study_id>2306001029</org_study_id>
      <nct_id>NCT05964855</nct_id>
    </id_info>
    <brief_title>Comparison of Various Prosthetic Foot-Ankle Mechanisms</brief_title>
    <official_title>Comparison of Various Prosthetic Foot-Ankle Mechanisms</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Massachusetts Institute of Technology</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Massachusetts Institute of Technology</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_unapproved_device>Yes</is_unapproved_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        In summary, subjects will be asked to wear a number of sensors and use different ankle-foot&#xD;
        prostheses in place of their customary prosthesis. Data will be collected from the wearable&#xD;
        sensors, VICON motion capture system, video cameras, and force sensors in the ground as they&#xD;
        walk on level-ground, on a treadmill, and on stairs. The controller of any powered prosthesis&#xD;
        will be electronically adjusted between trials or while the subject walks to determine how&#xD;
        their gait changes in response to these changes. Trials will also be conducted with a&#xD;
        standard passive prosthesis that would be prescribed for a person of similar height and&#xD;
        weight.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Subject Selection and Consent:&#xD;
  &#xD;
        Subjects will be selected based on the following priority. Subjects who have previously&#xD;
        participated in similar studies with the Biomechatronics lab and who have already been&#xD;
        screened for health and mobility level will be contacted first. If additional subjects are&#xD;
        needed, a recruitment flyer and screening questionnaire will be sent to potential candidates.&#xD;
        Copies of both the flyer and questionnaire are included in the attachments section. Prior to&#xD;
        the experimental sessions, subjects will be asked to read and sign a informed consent form&#xD;
        and will explain the project to them and answer any questions that they may have. They will&#xD;
        also be given time to become familiar with the equipment being used before beginning any&#xD;
        trials. If needed, subjects will be aligned and fitted by a professional prosthetist at A&#xD;
        Step Ahead Prosthetics in Burlington, MA. No personnel at A Step Ahead Prosthetics will&#xD;
        conduct research or have any vested interest in research outcomes or publication.&#xD;
  &#xD;
        Attire:&#xD;
  &#xD;
        Subjects will be asked to wear tight-fitting clothes, such as a skin-tight shirt, running&#xD;
        shorts and low-profile shoes. If this is not possible, clothes will be provided according to&#xD;
        subject needs. The investigators will provide and may require subjects to wear a skin-tight&#xD;
        Velcro outfit that allows us to place reflective balls for video camera capture.&#xD;
  &#xD;
        Location(s) and Timeline:&#xD;
  &#xD;
        Experimental sessions will be conducted in the MIT Biomechatronics Laboratory (E14-274), 75&#xD;
        Amherst St., Cambridge, MA 02139. Any alignment and fitting of prosthetic devices will take&#xD;
        place at A Step Ahead Prosthetics, 21 A. St., Burlington, MA 01803.&#xD;
  &#xD;
        Total study duration is expected to be 8 hours per subject, likely over two 4-hour sessions.&#xD;
        These sessions can be completed either in a single day or over two days. After subject&#xD;
        selection, the entire study is expected to take 3 months.&#xD;
  &#xD;
        Powered Prosthesis:&#xD;
  &#xD;
        Subjects will be given two computer-controlled, powered ankle-foot prostheses to attach in&#xD;
        place of their customary prosthesis during a session. These include the Blatchford Elan as&#xD;
        well as a variable-stiffness prosthesis developed in the Biomechatronics lab. These powered&#xD;
        prostheses have the capability of providing active assistance or changing mechanical&#xD;
        properties during walking. Controls can be adjusted either through a wireless link or&#xD;
        hardwire connection depending on the device. Subjects will be given as much time as necessary&#xD;
        to practice using the prostheses before the experiments begin.&#xD;
  &#xD;
        Passive Prosthesis:&#xD;
  &#xD;
        Subjects will be given three passive prostheses to attach in place of your customary&#xD;
        prosthesis during a session. These include the Ossur Pro-flex XC, a passive sliding-beam&#xD;
        prosthesis, and a passive prosthesis that can change ankle equilibrium angle manually.&#xD;
        Subjects will be given as much time as necessary to practice using the prosthesis before the&#xD;
        experiments begin.&#xD;
  &#xD;
        Data Collection:&#xD;
  &#xD;
        Data collection is expected to take place in two segments. The first segment consists of&#xD;
        level-ground walking on a treadmill at three speeds between 0.5-1.5m/s (slow to fast&#xD;
        walking). At each speed, all five prostheses will be tested, randomly selected, for 2mins&#xD;
        each. Motion will be captured with a VICON motion capture system, and ground reaction forces&#xD;
        will be measured using a Bertec force-sensitive treadmill. For each speed, once all&#xD;
        prostheses have been tested, each subject will be given a questionnaire to ascertain how each&#xD;
        prosthesis performed at heel strike (early stance), roll over (mid stance), and powered&#xD;
        plantar flexion (late stance). In addition, each subject will be asked how each prosthesis&#xD;
        generally performed, and their personal preference. This testing will occur across the three&#xD;
        walking speeds, resulting in three completed questionnaires.&#xD;
  &#xD;
        In addition, subjects will walk in a figure-8 pattern at a preferred gait speed around two&#xD;
        cones placed on the level-ground walking surface and separated by up to 30 feet. Subjects&#xD;
        will perform the walking figure-8 for a minimum of 5 times for each randomly-selected&#xD;
        prosthesis. Once all prostheses have been tested, each subject will be given a questionnaire&#xD;
        to ascertain how each prosthesis generally performed, and their personal preference.&#xD;
  &#xD;
        The second session will consist of slope and stair walking. Each subject will ascend and&#xD;
        descend stairs and a ramp inclined between 4°-10° from horizontal at their preferred speed,&#xD;
        in a randomly selected order. Motion will be captured with a VICON motion capture system, and&#xD;
        ground reaction forces will be measured using a Bertec force-sensitive treadmill for slope&#xD;
        ambulation, and a force-sensitive staircase for stair ambulation. All five prostheses will be&#xD;
        tested, randomly selected. Subjects will perform each of stair ascent and stair descent for a&#xD;
        minimum of 5 times per prosthesis. For slope ambulation on an instrumented treadmill,&#xD;
        subjects will walk for a total of 2mins for slope ascent and 2mins for slope descent with&#xD;
        each prosthesis. For each slope and stair ascent/descent, once all prostheses have been&#xD;
        tested, each subject will be given a questionnaire to ascertain how each prosthesis generally&#xD;
        performed, and their personal preference. This testing will occur across the slope terrain&#xD;
        types, as well as after the stair ascent/descent trial, resulting in three completed&#xD;
        questionnaires for each subject.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Anticipated">July 28, 2023</start_date>
    <completion_date type="Anticipated">July 10, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>User device preference for level-ground walking</measure>
      <time_frame>From enrollment to the end of trial (2 sessions, 8 hours total per patient)</time_frame>
      <description>Determine which device the users prefer for level-ground walking by gauging user feedback through an evaluation questionnaire. Evaluation units will be a sliding scale ranging from &quot;Very unfavorable&quot; to &quot;Very favorable&quot; with neutral in the middle. Subjects will be asked to rank the 5 interventions from best to worst for the specific task.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>User device preference for stair ascent &amp; descent</measure>
      <time_frame>From enrollment to the end of trial (2 sessions, 8 hours total per patient)</time_frame>
      <description>Determine which device the users prefer for stair ascent &amp; descent by gauging user feedback through an evaluation questionnaire. Evaluation units will be a sliding scale ranging from &quot;Very unfavorable&quot; to &quot;Very favorable&quot; with neutral in the middle. Subjects will be asked to rank the 5 interventions from best to worst for the specific task.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>User device preference for sloped ground ascent &amp; descent</measure>
      <time_frame>From enrollment to the end of trial (2 sessions, 8 hours total per patient)</time_frame>
      <description>Determine which device the users prefer for 8-degree sloped ground ascent &amp; descent by gauging user feedback through an evaluation questionnaire. Evaluation units will be a sliding scale ranging from &quot;Very unfavorable&quot; to &quot;Very favorable&quot; with neutral in the middle. Subjects will be asked to rank the 5 interventions from best to worst for the specific task.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Effect of device on level-ground walking gait</measure>
      <time_frame>From enrollment to the end of trial (2 sessions, 8 hours total per patient)</time_frame>
      <description>Evaluate the effect of the device on level-ground walking gait patterns. Gait will be measured with a VICON motion capture system. Unit of measure is gait symmetry.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Effect of device on stair ascent &amp; descent gait</measure>
      <time_frame>From enrollment to the end of trial (2 sessions, 8 hours total per patient)</time_frame>
      <description>Evaluate the effect of the device on stair ascent and descent gait patterns. Gait will be measured with a VICON motion capture system. Unit of measure is gait symmetry.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Effect of device on sloped ground walking gait</measure>
      <time_frame>From enrollment to the end of trial (2 sessions, 8 hours total per patient)</time_frame>
      <description>Evaluate the effect of the device on sloped ground walking gait patterns. Gait will be measured with a VICON motion capture system. Unit of measure is gait symmetry.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Effect of device on ground reaction force during ambulation</measure>
      <time_frame>From enrollment to the end of trial (2 sessions, 8 hours total per patient)</time_frame>
      <description>Evaluate the effect of the device on ground reaction forces during ambulation. Ground reaction forces will be measured with Bertec force plates. Unit of measure is ground reaction force in Newtons.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">10</enrollment>
    <condition>Transtibial Amputation - Unilateral</condition>
    <arm_group>
      <arm_group_label>Unilateral Subject Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Foot-ankle devices will be given to this group to evaluate and compare the devices.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>MIT Variable Stiffness Prosthesis</intervention_name>
      <description>Proprietary electronically-controlled prosthesis that can vary its effective stiffness.</description>
      <arm_group_label>Unilateral Subject Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>MIT Variable Equilibrium Angle Prosthesis</intervention_name>
      <description>Proprietary manually-controlled prosthesis that can vary its effective ankle equilibrium angle.</description>
      <arm_group_label>Unilateral Subject Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>MIT Sliding Beam Passive Prosthesis</intervention_name>
      <description>Proprietary fixed-stiffness passive foot-ankle prosthesis.</description>
      <arm_group_label>Unilateral Subject Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Ossur Pro-flex XC</intervention_name>
      <description>Commercially-available passive fixed-stiffness foot-ankle prosthesis by Ossur.</description>
      <arm_group_label>Unilateral Subject Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Blatchford Elan Variable-Dampening Prosthesis</intervention_name>
      <description>Commercially-available electronically-controlled prosthesis that can vary its effective dampening.</description>
      <arm_group_label>Unilateral Subject Group</arm_group_label>
      <other_name>Elan</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Person with unilateral transtibial amputation&#xD;
  &#xD;
            -  K3 or K4 Medicare mobility rating&#xD;
  &#xD;
            -  Ages 18-65&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Below K3 Medicare mobility rating&#xD;
  &#xD;
            -  Outside of age range (liability and safety reasons)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>MIT Media Laboratory</name>
        <address>
          <city>Cambridge</city>
          <state>Massachusetts</state>
          <zip>02139</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 11, 2023</study_first_submitted>
    <study_first_submitted_qc>July 19, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 19, 2023</last_update_submitted>
    <last_update_submitted_qc>July 19, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Foot-ankle device</keyword>
    <keyword>prosthesis</keyword>
    <keyword>mobility</keyword>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <provided_document_section>
      <provided_document>
        <document_type>Informed Consent Form</document_type>
        <document_has_protocol>No</document_has_protocol>
        <document_has_icf>Yes</document_has_icf>
        <document_has_sap>No</document_has_sap>
        <document_date>June 29, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/55/NCT05964855/ICF_000.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05964855
  org study id: 2306001029
  nct id: NCT05964855
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is unapproved device: Yes
  In summary, subjects will be asked to wear a number of sensors and use different ankle-foot
        prostheses in place of their customary prosthesis. Data will be collected from the wearable
        sensors, VICON motion capture system, video cameras, and force sensors in the ground as they
        walk on level-ground, on a treadmill, and on stairs. The controller of any powered prosthesis
        will be electronically adjusted between trials or while the subject walks to determine how
        their gait changes in response to these changes. Trials will also be conducted with a
        standard passive prosthesis that would be prescribed for a person of similar height and
        weight.
  Subject Selection and Consent:
  
        Subjects will be selected based on the following priority. Subjects who have previously
        participated in similar studies with the Biomechatronics lab and who have already been
        screened for health and mobility level will be contacted first. If additional subjects are
        needed, a recruitment flyer and screening questionnaire will be sent to potential candidates.
        Copies of both the flyer and questionnaire are included in the attachments section. Prior to
        the experimental sessions, subjects will be asked to read and sign a informed consent form
        and will explain the project to them and answer any questions that they may have. They will
        also be given time to become familiar with the equipment being used before beginning any
        trials. If needed, subjects will be aligned and fitted by a professional prosthetist at A
        Step Ahead Prosthetics in Burlington, MA. No personnel at A Step Ahead Prosthetics will
        conduct research or have any vested interest in research outcomes or publication.
  
        Attire:
  
        Subjects will be asked to wear tight-fitting clothes, such as a skin-tight shirt, running
        shorts and low-profile shoes. If this is not possible, clothes will be provided according to
        subject needs. The investigators will provide and may require subjects to wear a skin-tight
        Velcro outfit that allows us to place reflective balls for video camera capture.
  
        Location(s) and Timeline:
  
        Experimental sessions will be conducted in the MIT Biomechatronics Laboratory (E14-274), 75
        Amherst St., Cambridge, MA 02139. Any alignment and fitting of prosthetic devices will take
        place at A Step Ahead Prosthetics, 21 A. St., Burlington, MA 01803.
  
        Total study duration is expected to be 8 hours per subject, likely over two 4-hour sessions.
        These sessions can be completed either in a single day or over two days. After subject
        selection, the entire study is expected to take 3 months.
  
        Powered Prosthesis:
  
        Subjects will be given two computer-controlled, powered ankle-foot prostheses to attach in
        place of their customary prosthesis during a session. These include the Blatchford Elan as
        well as a variable-stiffness prosthesis developed in the Biomechatronics lab. These powered
        prostheses have the capability of providing active assistance or changing mechanical
        properties during walking. Controls can be adjusted either through a wireless link or
        hardwire connection depending on the device. Subjects will be given as much time as necessary
        to practice using the prostheses before the experiments begin.
  
        Passive Prosthesis:
  
        Subjects will be given three passive prostheses to attach in place of your customary
        prosthesis during a session. These include the Ossur Pro-flex XC, a passive sliding-beam
        prosthesis, and a passive prosthesis that can change ankle equilibrium angle manually.
        Subjects will be given as much time as necessary to practice using the prosthesis before the
        experiments begin.
  
        Data Collection:
  
        Data collection is expected to take place in two segments. The first segment consists of
        level-ground walking on a treadmill at three speeds between 0.5-1.5m/s (slow to fast
        walking). At each speed, all five prostheses will be tested, randomly selected, for 2mins
        each. Motion will be captured with a VICON motion capture system, and ground reaction forces
        will be measured using a Bertec force-sensitive treadmill. For each speed, once all
        prostheses have been tested, each subject will be given a questionnaire to ascertain how each
        prosthesis performed at heel strike (early stance), roll over (mid stance), and powered
        plantar flexion (late stance). In addition, each subject will be asked how each prosthesis
        generally performed, and their personal preference. This testing will occur across the three
        walking speeds, resulting in three completed questionnaires.
  
        In addition, subjects will walk in a figure-8 pattern at a preferred gait speed around two
        cones placed on the level-ground walking surface and separated by up to 30 feet. Subjects
        will perform the walking figure-8 for a minimum of 5 times for each randomly-selected
        prosthesis. Once all prostheses have been tested, each subject will be given a questionnaire
        to ascertain how each prosthesis generally performed, and their personal preference.
  
        The second session will consist of slope and stair walking. Each subject will ascend and
        descend stairs and a ramp inclined between 4°-10° from horizontal at their preferred speed,
        in a randomly selected order. Motion will be captured with a VICON motion capture system, and
        ground reaction forces will be measured using a Bertec force-sensitive treadmill for slope
        ambulation, and a force-sensitive staircase for stair ambulation. All five prostheses will be
        tested, randomly selected. Subjects will perform each of stair ascent and stair descent for a
        minimum of 5 times per prosthesis. For slope ambulation on an instrumented treadmill,
        subjects will walk for a total of 2mins for slope ascent and 2mins for slope descent with
        each prosthesis. For each slope and stair ascent/descent, once all prostheses have been
        tested, each subject will be given a questionnaire to ascertain how each prosthesis generally
        performed, and their personal preference. This testing will occur across the slope terrain
        types, as well as after the stair ascent/descent trial, resulting in three completed
        questionnaires for each subject.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: User device preference for level-ground walking
  time frame: From enrollment to the end of trial (2 sessions, 8 hours total per patient)
  description: Determine which device the users prefer for level-ground walking by gauging user feedback through an evaluation questionnaire. Evaluation units will be a sliding scale ranging from "Very unfavorable" to "Very favorable" with neutral in the middle. Subjects will be asked to rank the 5 interventions from best to worst for the specific task.
  measure: User device preference for stair ascent & descent
  time frame: From enrollment to the end of trial (2 sessions, 8 hours total per patient)
  description: Determine which device the users prefer for stair ascent & descent by gauging user feedback through an evaluation questionnaire. Evaluation units will be a sliding scale ranging from "Very unfavorable" to "Very favorable" with neutral in the middle. Subjects will be asked to rank the 5 interventions from best to worst for the specific task.
  measure: User device preference for sloped ground ascent & descent
  time frame: From enrollment to the end of trial (2 sessions, 8 hours total per patient)
  description: Determine which device the users prefer for 8-degree sloped ground ascent & descent by gauging user feedback through an evaluation questionnaire. Evaluation units will be a sliding scale ranging from "Very unfavorable" to "Very favorable" with neutral in the middle. Subjects will be asked to rank the 5 interventions from best to worst for the specific task.
  measure: Effect of device on level-ground walking gait
  time frame: From enrollment to the end of trial (2 sessions, 8 hours total per patient)
  description: Evaluate the effect of the device on level-ground walking gait patterns. Gait will be measured with a VICON motion capture system. Unit of measure is gait symmetry.
  measure: Effect of device on stair ascent & descent gait
  time frame: From enrollment to the end of trial (2 sessions, 8 hours total per patient)
  description: Evaluate the effect of the device on stair ascent and descent gait patterns. Gait will be measured with a VICON motion capture system. Unit of measure is gait symmetry.
  measure: Effect of device on sloped ground walking gait
  time frame: From enrollment to the end of trial (2 sessions, 8 hours total per patient)
  description: Evaluate the effect of the device on sloped ground walking gait patterns. Gait will be measured with a VICON motion capture system. Unit of measure is gait symmetry.
  measure: Effect of device on ground reaction force during ambulation
  time frame: From enrollment to the end of trial (2 sessions, 8 hours total per patient)
  description: Evaluate the effect of the device on ground reaction forces during ambulation. Ground reaction forces will be measured with Bertec force plates. Unit of measure is ground reaction force in Newtons.
  arm group label: Unilateral Subject Group
  arm group type: Experimental
  description: Foot-ankle devices will be given to this group to evaluate and compare the devices.
  intervention type: Device
  intervention name: MIT Variable Stiffness Prosthesis
  description: Proprietary electronically-controlled prosthesis that can vary its effective stiffness.
  arm group label: Unilateral Subject Group
  intervention type: Device
  intervention name: MIT Variable Equilibrium Angle Prosthesis
  description: Proprietary manually-controlled prosthesis that can vary its effective ankle equilibrium angle.
  arm group label: Unilateral Subject Group
  intervention type: Device
  intervention name: MIT Sliding Beam Passive Prosthesis
  description: Proprietary fixed-stiffness passive foot-ankle prosthesis.
  arm group label: Unilateral Subject Group
  intervention type: Device
  intervention name: Ossur Pro-flex XC
  description: Commercially-available passive fixed-stiffness foot-ankle prosthesis by Ossur.
  arm group label: Unilateral Subject Group
  intervention type: Device
  intervention name: Blatchford Elan Variable-Dampening Prosthesis
  description: Commercially-available electronically-controlled prosthesis that can vary its effective dampening.
  arm group label: Unilateral Subject Group
  other name: Elan
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 65 Years
  healthy volunteers: No
  facility: 
  country: United States
  responsible party type: Sponsor
  sharing ipd: Undecided
  provided document: 