<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/NCT03837665</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00140843</org_study_id>
    <nct_id>NCT03837665</nct_id>
  </id_info>
  <brief_title>Efficacy of Platelet Enriched Plasma in Preventing Surgery for Patients With Chronic Tympanic Membrane Perforation</brief_title>
  <official_title>Efficacy of Platelet Enriched Plasma in Preventing Surgery for Patients With Chronic Tympanic Membrane Perforation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Kansas Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Kansas Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      By doing this study, researchers hope to find out if platelet rich plasma (PRP) can heal&#xD;
      holes in the eardrum as an alternative to surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 2, 2018</start_date>
  <completion_date type="Anticipated">June 30, 2019</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2019</primary_completion_date>
  <phase>Phase 1/Phase 2</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>Prevention of patients requiring surgery</measure>
    <time_frame>6 Weeks</time_frame>
    <description>Number of participants that are able to avoid surgery for their perforation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to healing</measure>
    <time_frame>6 Weeks</time_frame>
    <description>Size of perforation</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Tympanic Membrane Perforation</condition>
  <arm_group>
    <arm_group_label>PRP Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants receive platelet rich plasma treatment. Participants will be asked to make up to 5 trips to the clinic (one for eligibility, one for the PRP, three follow-up visits). Participation is expected to last up to about 6 weeks. After the second visit and application of PRP, patients will be monitored closely for any complications or concerns. This will include a follow up phone call 3-5 days after the initial application of PRP. Patients will also be followed closely in 2 week intervals or sooner should any problems or concerns arise.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Platelet Rich Plasma</intervention_name>
    <description>Platelet Rich Plasma (PRP) is blood plasma that has been enriched with platelets.</description>
    <arm_group_label>PRP Treatment</arm_group_label>
    <other_name>PRP</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who meet criteria for tympanoplasty procedure&#xD;
&#xD;
          -  Willing to comply with the protocol and attend all study visits&#xD;
&#xD;
          -  Able to provide written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who have previously undergone middle ear or lateral skull base surgery&#xD;
&#xD;
          -  Patients who would not qualify for a tympanoplasty&#xD;
&#xD;
          -  Any type of platelet disorder, cancer, or ongoing systemic infection&#xD;
&#xD;
          -  Any type of hemodynamic instability, septicemia, infection, tobacco use, any use of&#xD;
             steroids to the ear drums&#xD;
&#xD;
          -  Type I diabetes or other autoimmune pathology&#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>Hinrich Staecker, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Kansas Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Kevin Sykes, PhD</last_name>
    <phone>913-588-7154</phone>
    <email>ksykes@kumc.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Bryan Humphrey</last_name>
    <email>bhumphrey@kumc.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Kansas Medical Center</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66160</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Matthew Shew, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Kevin Sykes, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 8, 2019</study_first_submitted>
  <study_first_submitted_qc>February 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 12, 2019</study_first_posted>
  <last_update_submitted>February 27, 2019</last_update_submitted>
  <last_update_submitted_qc>February 27, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 1, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Kansas Medical Center</investigator_affiliation>
    <investigator_full_name>Hinrich Staecker, MD, PhD</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Platelet Rich Plasma</keyword>
  <keyword>TM perforations</keyword>
  <keyword>Hearing loss</keyword>
  <keyword>Hole in the eardrum</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tympanic Membrane Perforation</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/NCT03837665
org study id: STUDY00140843
nct id: NCT03837665
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
By doing this study, researchers hope to find out if platelet rich plasma (PRP) can heal
      holes in the eardrum as an alternative to surgery.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Prevention of patients requiring surgery
time frame: 6 Weeks
description: Number of participants that are able to avoid surgery for their perforation.
measure: Time to healing
time frame: 6 Weeks
description: Size of perforation
arm group label: PRP Treatment
arm group type: Experimental
description: Participants receive platelet rich plasma treatment. Participants will be asked to make up to 5 trips to the clinic (one for eligibility, one for the PRP, three follow-up visits). Participation is expected to last up to about 6 weeks. After the second visit and application of PRP, patients will be monitored closely for any complications or concerns. This will include a follow up phone call 3-5 days after the initial application of PRP. Patients will also be followed closely in 2 week intervals or sooner should any problems or concerns arise.
intervention type: Biological
intervention name: Platelet Rich Plasma
description: Platelet Rich Plasma (PRP) is blood plasma that has been enriched with platelets.
arm group label: PRP Treatment
other name: PRP
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Hinrich Staecker, MD
role: Principal Investigator
affiliation: University of Kansas Medical Center
last name: Kevin Sykes, PhD
phone: 913-588-7154
email: ksykes@kumc.edu
last name: Bryan Humphrey
email: bhumphrey@kumc.edu
facility: 
status: Recruiting
investigator: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Kansas Medical Center
investigator full name: Hinrich Staecker, MD, PhD
investigator title: Professor
mesh term: Tympanic Membrane Perforation