<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/NCT03236064</url>
  </required_header>
  <id_info>
    <org_study_id>696230-1</org_study_id>
    <nct_id>NCT03236064</nct_id>
  </id_info>
  <brief_title>Conversion of Seddon III Nerve Injury to Seddon I/II Nerve Injury</brief_title>
  <official_title>Conversion of Seddon III Nerve Injury to Seddon I/II Nerve Injury</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>WellSpan Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Neuraptive Therapeutics Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>WellSpan Health</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate the safety and efficacy of PEG 3350 for use in nerve repair.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To demonstrate more rapid and increased return of function by PEG-fusion compared to the best&#xD;
      current nerve repair techniques. Neurorrhaphy is not new, being performed now for over 150&#xD;
      years much research has been performed. PEG-Axon fusion on the other hand is relatively new&#xD;
      in mammals. Success has already been obtained by two institutions in the rat sciatic nerve&#xD;
      transections, demonstrating rapid return of behavioral function4. These however are very&#xD;
      controlled injuries and unclear how well these will translate into human studies. For this&#xD;
      reason 3 separate clinical studies in increasing order of complexity are proposed.&#xD;
&#xD;
      The first study proposed will be PEG fusion in digital nerve lacerations. Two goals will be&#xD;
      demonstrated; improved innervation density and improved innervation threshold compared to&#xD;
      traditional repair, and complication rate similar or less than traditional repair. This will&#xD;
      demonstrate the safety and efficacy of the procedure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>May 2016</start_date>
  <completion_date type="Anticipated">May 2024</completion_date>
  <primary_completion_date type="Anticipated">May 2024</primary_completion_date>
  <phase>Phase 1</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>To demonstrate more rapid and increased return of function by PEG-fusion compared to the best current nerve repair techniques</measure>
    <time_frame>12 months</time_frame>
    <description>Three goals will be demonstrated; improved innervation density and improved innervation threshold compared to traditional repair, rapid return of motor function and complication rate similar or less than traditional repair. This will demonstrate the safety and efficacy of the procedure</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Injury of Other Nerves at Wrist and Hand Level of Unspecified Arm, Initial Encounter</condition>
  <arm_group>
    <arm_group_label>Nerve injury to palm and fingers</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Adult patients with acute clean nerve transections of the higher arm injuries in the forearm, wrist, palm and digits of the hand will be recruited</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Polyethylene Glycols</intervention_name>
    <description>Demonstrate more rapid and increased return of function by PEG-fusion compared to best current nerve repair techniques</description>
    <arm_group_label>Nerve injury to palm and fingers</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        -  Isolated nerve transections of the digits, forearm, wrist, and palm will be included.&#xD;
&#xD;
          -  Class III nerve injury (Sunderland's 4th or 5th degree injury)&#xD;
&#xD;
          -  Nerve injuries that can be prepared using minimal or acceptable tension (according to&#xD;
             surgeon discretion).&#xD;
&#xD;
          -  Pregnant and breastfeeding women cannot participate because of possible unknown and&#xD;
             unpredictable risks to the unborn child.&#xD;
&#xD;
          -  Injuries beyond 24 hours will be excluded&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Richard C Trevino, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>WellSpan York Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Richard C Trevino, MD</last_name>
    <phone>717-812-4090</phone>
    <email>rctrevino@trevino6.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>George Bittner, PhD</last_name>
    <phone>512-923-3735</phone>
    <email>bittner@austin.utexas.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>WellSpanYork Hospital</name>
      <address>
        <city>York</city>
        <state>Pennsylvania</state>
        <zip>17405</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Richard C Trevino, MD</last_name>
      <phone>717-812-4090</phone>
      <email>rctrevino@trevino6.com</email>
    </contact>
    <contact_backup>
      <last_name>E</last_name>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>July 25, 2016</study_first_submitted>
  <study_first_submitted_qc>July 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 1, 2017</study_first_posted>
  <last_update_submitted>January 22, 2021</last_update_submitted>
  <last_update_submitted_qc>January 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 26, 2021</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>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/NCT03236064
org study id: 696230-1
nct id: NCT03236064
lead sponsor: 
collaborator: 
has dmc: No
This study will evaluate the safety and efficacy of PEG 3350 for use in nerve repair.
To demonstrate more rapid and increased return of function by PEG-fusion compared to the best
      current nerve repair techniques. Neurorrhaphy is not new, being performed now for over 150
      years much research has been performed. PEG-Axon fusion on the other hand is relatively new
      in mammals. Success has already been obtained by two institutions in the rat sciatic nerve
      transections, demonstrating rapid return of behavioral function4. These however are very
      controlled injuries and unclear how well these will translate into human studies. For this
      reason 3 separate clinical studies in increasing order of complexity are proposed.

      The first study proposed will be PEG fusion in digital nerve lacerations. Two goals will be
      demonstrated; improved innervation density and improved innervation threshold compared to
      traditional repair, and complication rate similar or less than traditional repair. This will
      demonstrate the safety and efficacy of the procedure.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: To demonstrate more rapid and increased return of function by PEG-fusion compared to the best current nerve repair techniques
time frame: 12 months
description: Three goals will be demonstrated; improved innervation density and improved innervation threshold compared to traditional repair, rapid return of motor function and complication rate similar or less than traditional repair. This will demonstrate the safety and efficacy of the procedure
arm group label: Nerve injury to palm and fingers
arm group type: Experimental
description: Adult patients with acute clean nerve transections of the higher arm injuries in the forearm, wrist, palm and digits of the hand will be recruited
intervention type: Drug
intervention name: Polyethylene Glycols
description: Demonstrate more rapid and increased return of function by PEG-fusion compared to best current nerve repair techniques
arm group label: Nerve injury to palm and fingers
criteria: 
gender: All
minimum age: 16 Years
maximum age: 65 Years
healthy volunteers: No
last name: Richard C Trevino, MD
role: Principal Investigator
affiliation: WellSpan York Hospital
last name: Richard C Trevino, MD
phone: 717-812-4090
email: rctrevino@trevino6.com
last name: George Bittner, PhD
phone: 512-923-3735
email: bittner@austin.utexas.edu
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Sponsor
mesh term: Wounds and Injuries