<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/NCT02993276</url>
  </required_header>
  <id_info>
    <org_study_id>CR-02</org_study_id>
    <nct_id>NCT02993276</nct_id>
  </id_info>
  <brief_title>Evaluation of NEUROCAP® In the Treatment of Symptomatic Neuroma</brief_title>
  <official_title>Protect Neuro - Prospective Cohort Evaluation of NEUROCAP® In the Treatment of Symptomatic Neuroma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Polyganics BV</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Polyganics BV</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      PROSPECTIVE COHORT EVALUATION OF NEUROCAP® In the Treatment of symptomatic Neuroma (PROTECT&#xD;
      Neuro)&#xD;
&#xD;
      This post-market surveillance study is conducted to provide post market surveillance&#xD;
      information regarding long-term performance and ease of use of the Polyganics nerve capping&#xD;
      device (NEUROCAP®) for reduction of the development of peripheral symptomatic end-neuroma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Device description NEUROCAP®, a bioresorbable nerve capping device based upon the&#xD;
           NEUROLAC® nerve guide, is indicated to protect a peripheral nerve end and to separate&#xD;
           the nerve from surrounding environment to reduce the development of a symptomatic&#xD;
           neuroma. NEUROCAP® is composed of the same biocompatible, bioresorbable copolyester&#xD;
           composing the NEUROLAC® nerve guide, Poly(68/32[15/85 D/L] Lactide-Ԑ-Caprolactone)&#xD;
           (PLCL).&#xD;
&#xD;
        2. Objective This post-market surveillance study is conducted to provide post market&#xD;
           surveillance information regarding long-term performance and ease of use of the&#xD;
           Polyganics nerve capping device (NEUROCAP®) for reduction of the development of&#xD;
           peripheral symptomatic end-neuroma.&#xD;
&#xD;
        3. Study design This post-market surveillance study consists of a cohort study to provide&#xD;
           post market surveillance information regarding long-term performance and ease of use of&#xD;
           the NEUROCAP® for reduction of the development of peripheral symptomatic end-neuroma in&#xD;
           the upper and lower extremity. Sub analyses will be performed regarding demographics and&#xD;
           medical background.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 17, 2017</start_date>
  <completion_date type="Actual">August 30, 2020</completion_date>
  <primary_completion_date type="Actual">July 6, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Visual Analog Scale (VAS) for Pain</measure>
    <time_frame>2 years</time_frame>
    <description>Subjective pain score as indicated by the patient on a scale of 1-100.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Recurrence of Neuroma</measure>
    <time_frame>2 years</time_frame>
    <description>Recurrence of neuroma as assessed by clinical assessment by the surgeon.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Elliot Neuroma questionnaire</measure>
    <time_frame>2 years</time_frame>
    <description>Type of pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>QuickDASH</measure>
    <time_frame>2 years</time_frame>
    <description>Daily functioning upper limb</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Goals questionnaire</measure>
    <time_frame>2 years</time_frame>
    <description>Daily functioning lower limb</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Type of Pain Medication</measure>
    <time_frame>2 years</time_frame>
    <description>Type of pain medication currently taken</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Amount of Pain Medication</measure>
    <time_frame>2 years</time_frame>
    <description>Amount of pain medication currently taken</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">73</enrollment>
  <condition>Neuroma</condition>
  <arm_group>
    <arm_group_label>Treatment Group</arm_group_label>
    <description>All subjects receiving the Neurocap® device when surgically treated for their symptomatic peripheral end-neuroma.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Neurocap®</intervention_name>
    <description>NEUROCAP®, a bioresorbable nerve capping device based upon the NEUROLAC® nerve guide, is indicated to protect a peripheral nerve end and to separate the nerve from surrounding environment to reduce the development of a symptomatic neuroma.</description>
    <arm_group_label>Treatment Group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Peripheral symptomatic end-neuroma patients indicated for surgical treatment of the&#xD;
        neuroma.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subjects who are able to provide a written informed consent prior to participating in&#xD;
             the clinical investigation.&#xD;
&#xD;
          2. Subjects who are able to comply with the follow-up or other requirements.&#xD;
&#xD;
          3. Subjects who are ≥ 18 years old.&#xD;
&#xD;
          4. Subjects with a diagnosis of peripheral symptomatic (end-) neuroma in the upper limb.&#xD;
&#xD;
          5. Subjects with a positive Tinel's sign.&#xD;
&#xD;
          6. Symptomatic neuroma confirmed by pain relief following a 10min ± 2min nerve block with&#xD;
             Xylocaine (Lidocaine) - Pain relief defined as minimally 50% reduction in VAS&#xD;
             questionnaire score.&#xD;
&#xD;
          7. Subjects that are indicated for surgery to treat symptomatic neuroma.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subjects who do not complete the informed consent.&#xD;
&#xD;
          2. Subjects who are not willing to follow post-surgery protocols (e.g. avoiding pressure&#xD;
             on the implant zone or immobilization).&#xD;
&#xD;
          3. Subjects who are unable to comply with the follow-up or other requirements and/or have&#xD;
             a life expectancy of less than 24 months.&#xD;
&#xD;
          4. Subjects with congenital neuropathy.&#xD;
&#xD;
          5. Insufficient amount of soft tissue to cover the investigational device, as assessed by&#xD;
             the surgeon. Use of the device over a joint is advised against.&#xD;
&#xD;
          6. Subjects who have had historical radiotherapy in the area of the (end-) neuroma.&#xD;
&#xD;
          7. Subjects who have a known allergy to anesthetic agent or bioresorbable copolyester&#xD;
             Poly(68/32[15/85 D/L] Lactide-ε-Caprolactone) (PLCL).&#xD;
&#xD;
          8. Proximal nerve end &gt; 8mm.&#xD;
&#xD;
          9. Pregnancy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Arizona Center for Hand Surgery</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Stanford Medical Center Hand and Upper Limb Center</name>
      <address>
        <city>Redwood City</city>
        <state>California</state>
        <zip>94063</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Buncke Clinic</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Veterans affairs Medical Center Portland</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Geisinger Clinic</name>
      <address>
        <city>Danville</city>
        <state>Pennsylvania</state>
        <zip>17822</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pennsylvania</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104-6061</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Philadelphia Hand Center (affiliated to Thomas Jefferson Hospital)</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Commonwealth University Medical Center</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Chirurgicale Victor Hugo Paris</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>BG Trauma Center Frankfurt am Main GmbH</name>
      <address>
        <city>Frankfurt am Main</city>
        <zip>60389</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ospedale San Guiseppe Milano</name>
      <address>
        <city>Milano</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Parc Sanitari Sant Joan de Deu</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sahlgrenska University Hospital Gothenburg</name>
      <address>
        <city>Goteborg</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Linköping</name>
      <address>
        <city>Linkoping</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Lund - Department of Hand Surgery</name>
      <address>
        <city>Malmo</city>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Birmingham Hand Centre</name>
      <address>
        <city>Birmingham</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Spain</country>
    <country>Sweden</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Netherlands</country>
  </removed_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>December 8, 2016</study_first_submitted>
  <study_first_submitted_qc>December 12, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 15, 2016</study_first_posted>
  <last_update_submitted>September 9, 2020</last_update_submitted>
  <last_update_submitted_qc>September 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neuroma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02993276
org study id: CR-02
nct id: NCT02993276
lead sponsor: 
has dmc: Yes
PROSPECTIVE COHORT EVALUATION OF NEUROCAP® In the Treatment of symptomatic Neuroma (PROTECT
      Neuro)

      This post-market surveillance study is conducted to provide post market surveillance
      information regarding long-term performance and ease of use of the Polyganics nerve capping
      device (NEUROCAP®) for reduction of the development of peripheral symptomatic end-neuroma.
1. Device description NEUROCAP®, a bioresorbable nerve capping device based upon the
           NEUROLAC® nerve guide, is indicated to protect a peripheral nerve end and to separate
           the nerve from surrounding environment to reduce the development of a symptomatic
           neuroma. NEUROCAP® is composed of the same biocompatible, bioresorbable copolyester
           composing the NEUROLAC® nerve guide, Poly(68/32[15/85 D/L] Lactide-Ԑ-Caprolactone)
           (PLCL).

        2. Objective This post-market surveillance study is conducted to provide post market
           surveillance information regarding long-term performance and ease of use of the
           Polyganics nerve capping device (NEUROCAP®) for reduction of the development of
           peripheral symptomatic end-neuroma.

        3. Study design This post-market surveillance study consists of a cohort study to provide
           post market surveillance information regarding long-term performance and ease of use of
           the NEUROCAP® for reduction of the development of peripheral symptomatic end-neuroma in
           the upper and lower extremity. Sub analyses will be performed regarding demographics and
           medical background.
observational model: Cohort
time perspective: Prospective
measure: Visual Analog Scale (VAS) for Pain
time frame: 2 years
description: Subjective pain score as indicated by the patient on a scale of 1-100.
measure: Recurrence of Neuroma
time frame: 2 years
description: Recurrence of neuroma as assessed by clinical assessment by the surgeon.
measure: Elliot Neuroma questionnaire
time frame: 2 years
description: Type of pain
measure: QuickDASH
time frame: 2 years
description: Daily functioning upper limb
measure: Goals questionnaire
time frame: 2 years
description: Daily functioning lower limb
measure: Type of Pain Medication
time frame: 2 years
description: Type of pain medication currently taken
measure: Amount of Pain Medication
time frame: 2 years
description: Amount of pain medication currently taken
arm group label: Treatment Group
description: All subjects receiving the Neurocap® device when surgically treated for their symptomatic peripheral end-neuroma.
intervention type: Device
intervention name: Neurocap®
description: NEUROCAP®, a bioresorbable nerve capping device based upon the NEUROLAC® nerve guide, is indicated to protect a peripheral nerve end and to separate the nerve from surrounding environment to reduce the development of a symptomatic neuroma.
arm group label: Treatment Group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
country: Germany
country: Italy
country: Spain
country: Sweden
country: United Kingdom
country: United States
country: Netherlands
responsible party type: Sponsor
mesh term: Neuroma
sharing ipd: No