<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/NCT02970864</url>
  </required_header>
  <id_info>
    <org_study_id>R116863</org_study_id>
    <secondary_id>2016-001667-37</secondary_id>
    <nct_id>NCT02970864</nct_id>
  </id_info>
  <brief_title>A Phase I Trial of a Novel Synthetic Polymer Nerve Conduit 'Polynerve' in Participants With Sensory Digital Nerve Injury</brief_title>
  <acronym>UMANC</acronym>
  <official_title>A Phase I Trial of a Novel Synthetic Polymer Nerve Conduit 'Polynerve' in Participants With Sensory Digital Nerve Injury</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Manchester</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute for Health Research, United Kingdom</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Manchester</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Participants with a traumatic sensory nerve injury in the hand will be recruited to the&#xD;
      study. Participants found to have a nerve gap of at least 5 mm and no greater than 20mm will&#xD;
      undergo repair with the Polynerve. Participants will be followed up regularly, observed for&#xD;
      device-related complications and to assess the return of sensory innervation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Peripheral nerve injuries are a common occurrence, with approximately 9000 cases in the&#xD;
      United Kingdom (UK) occurring each year. Most are in a predominantly young and working&#xD;
      population. Where surgical reconstruction is required to repair the peripheral nerve injury,&#xD;
      techniques employed have changed little in the last 50-60 years with many factors influencing&#xD;
      the outcomes, such as age of patient, timing, level and extent of injury, method of repair&#xD;
      and the surgeon's skill .&#xD;
&#xD;
      Despite advances in microsurgical nerve repair techniques, functional recovery is often poor&#xD;
      e.g. resulting impaired hand sensation, reduced motor function and frequent pain and cold&#xD;
      intolerance. This can have a profound and permanent impact on the patient's recovery and&#xD;
      subsequent quality of life. Nerve repair has significant health, social and cost implications&#xD;
      with the treatment and rehabilitation of an employed person, estimated to be EUR 51,238.&#xD;
&#xD;
      Peripheral nerve injury usually presents with nerve stumps that can be approximated in&#xD;
      surgical repair: direct, end-to-end suture repair of the epineurium (neurorrhaphy). Excessive&#xD;
      tension over the suture line leads to poor results; therefore when the nerve stumps cannot be&#xD;
      approximated without tension, an alternative surgical method is required.&#xD;
&#xD;
      Where the nerve gap exceeds more than 5 mm, there are two fundamental options, either 'nerve&#xD;
      grafting' or 'tubulisation' using a bridging material. This trial will examine the&#xD;
      first-in-man use of a new nerve conduit device 'Polynerve' to repair small nerve gaps in&#xD;
      digital sensory nerves of the hand. Polynerve is a degradable co-polymer of Poly&#xD;
      ε-caprolactone (PCL) and Poly (L-lactic acid) (PLA) which is shaped as a cylinder with a&#xD;
      novel internal lumen consisting of a specific micro-grooved architecture.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 17, 2017</start_date>
  <completion_date type="Actual">May 6, 2021</completion_date>
  <primary_completion_date type="Actual">August 31, 2019</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Assessment of safety and tolerability: number of patients with treatment-related adverse events as assessed by the Clavien-Dindo classification of surgical complications</measure>
    <time_frame>1 year</time_frame>
    <description>To assess the safety and tolerability of use of the polymer biomaterial nerve conduit to repair a sensory nerve transection of the hand</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Measurement of efficacy: Sensory nerve function measured by two-point discrimination (2PD), the Weinstein Enhanced Sensory Test (WEST) monofilaments, and locognosia</measure>
    <time_frame>1 year</time_frame>
    <description>To measure efficacy of the polymer biomaterial nerve conduit to support nerve regeneration following the transection of the sensory nerve of the hand</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">17</enrollment>
  <condition>Injury of Nerves at Wrist and Hand Level</condition>
  <arm_group>
    <arm_group_label>Polynerve</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants found to have a nerve gap of at least 5 mm and no greater than 20mm will undergo repair with the Polynerve.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Polynerve</intervention_name>
    <description>Polymer biomaterial nerve conduit</description>
    <arm_group_label>Polynerve</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Provision of informed consent prior to any trial specific procedures&#xD;
&#xD;
          2. Traumatic injury/injuries to the hand with clinical suspicion of sensory nerve&#xD;
             transection mandating surgical exploration&#xD;
&#xD;
          3. Male and females aged 18-80&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Concomitant injuries requiring surgical treatment from other specialists&#xD;
&#xD;
          2. Specified co-morbidities that would increase a participants risk of infection&#xD;
             including diabetes, renal/liver disease, autoimmune diseases, primary or secondary&#xD;
             immunocompromised participants (including immunosuppressive drugs or known disease&#xD;
             resulting in suppressed immunity)&#xD;
&#xD;
          3. A stated hypersensitivity or allergy to the polymers PCL/PLA&#xD;
&#xD;
          4. Any other significant co-morbidity impacting on the risk of surgery (to be determined&#xD;
             by the multi-disciplinary team (MDT))&#xD;
&#xD;
          5. Known to have participated in a clinical trial of an investigational agent or device&#xD;
             in the previous 30 days.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Adam Reid</last_name>
    <role>Study Chair</role>
    <affiliation>University of Manchester</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Wythenshawe Hospital, Manchester University NHS Foundation Trust</name>
      <address>
        <city>Wythenshawe</city>
        <state>Manchester</state>
        <zip>M23 9LT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>November 15, 2016</study_first_submitted>
  <study_first_submitted_qc>November 18, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2016</study_first_posted>
  <last_update_submitted>October 31, 2022</last_update_submitted>
  <last_update_submitted_qc>October 31, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 1, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Manchester</investigator_affiliation>
    <investigator_full_name>Adam Reid</investigator_full_name>
    <investigator_title>Chief Investigator</investigator_title>
  </responsible_party>
  <keyword>Nerve regeneration</keyword>
  <keyword>Peripheral nerve injury</keyword>
  <keyword>Nerve conduits</keyword>
  <keyword>Sensory nerve transection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and Injuries</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/NCT02970864
org study id: R116863
secondary id: 2016-001667-37
nct id: NCT02970864
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Participants with a traumatic sensory nerve injury in the hand will be recruited to the
      study. Participants found to have a nerve gap of at least 5 mm and no greater than 20mm will
      undergo repair with the Polynerve. Participants will be followed up regularly, observed for
      device-related complications and to assess the return of sensory innervation.
Peripheral nerve injuries are a common occurrence, with approximately 9000 cases in the
      United Kingdom (UK) occurring each year. Most are in a predominantly young and working
      population. Where surgical reconstruction is required to repair the peripheral nerve injury,
      techniques employed have changed little in the last 50-60 years with many factors influencing
      the outcomes, such as age of patient, timing, level and extent of injury, method of repair
      and the surgeon's skill .

      Despite advances in microsurgical nerve repair techniques, functional recovery is often poor
      e.g. resulting impaired hand sensation, reduced motor function and frequent pain and cold
      intolerance. This can have a profound and permanent impact on the patient's recovery and
      subsequent quality of life. Nerve repair has significant health, social and cost implications
      with the treatment and rehabilitation of an employed person, estimated to be EUR 51,238.

      Peripheral nerve injury usually presents with nerve stumps that can be approximated in
      surgical repair: direct, end-to-end suture repair of the epineurium (neurorrhaphy). Excessive
      tension over the suture line leads to poor results; therefore when the nerve stumps cannot be
      approximated without tension, an alternative surgical method is required.

      Where the nerve gap exceeds more than 5 mm, there are two fundamental options, either 'nerve
      grafting' or 'tubulisation' using a bridging material. This trial will examine the
      first-in-man use of a new nerve conduit device 'Polynerve' to repair small nerve gaps in
      digital sensory nerves of the hand. Polynerve is a degradable co-polymer of Poly
      ε-caprolactone (PCL) and Poly (L-lactic acid) (PLA) which is shaped as a cylinder with a
      novel internal lumen consisting of a specific micro-grooved architecture.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Assessment of safety and tolerability: number of patients with treatment-related adverse events as assessed by the Clavien-Dindo classification of surgical complications
time frame: 1 year
description: To assess the safety and tolerability of use of the polymer biomaterial nerve conduit to repair a sensory nerve transection of the hand
measure: Measurement of efficacy: Sensory nerve function measured by two-point discrimination (2PD), the Weinstein Enhanced Sensory Test (WEST) monofilaments, and locognosia
time frame: 1 year
description: To measure efficacy of the polymer biomaterial nerve conduit to support nerve regeneration following the transection of the sensory nerve of the hand
arm group label: Polynerve
arm group type: Experimental
description: Participants found to have a nerve gap of at least 5 mm and no greater than 20mm will undergo repair with the Polynerve.
intervention type: Device
intervention name: Polynerve
description: Polymer biomaterial nerve conduit
arm group label: Polynerve
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Adam Reid
role: Study Chair
affiliation: University of Manchester
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: University of Manchester
investigator full name: Adam Reid
investigator title: Chief Investigator
mesh term: Wounds and Injuries