<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/NCT03019380</url>
  </required_header>
  <id_info>
    <org_study_id>0125-16-KMC-CTIL</org_study_id>
    <nct_id>NCT03019380</nct_id>
  </id_info>
  <brief_title>A Clinical Trial to Test the Saftey and Success Rate for a Cerrumen Cleaning Device - &quot;Wondertip&quot;.</brief_title>
  <official_title>Testing the Effectivness and Safety of the Wondertip</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kaplan Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kaplan Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Wondertip is a silicone single use device with a coil end, designed for the purpose of&#xD;
      evacuating impacted cerumen of external ear canals. This trial aims at testing the safety and&#xD;
      efficacy of this device. The participating investigators will be ENT doctors with the skill&#xD;
      of examining the treating ear problems.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cerumen is ear wax, a combination of dead skin cells of the external ear canal, sebaceous&#xD;
      glands secretions and ceruminous sweat glands secretions. Cerumen exists in a range of people&#xD;
      but sometimes it become an obstacle to patients or caregivers. Cerumen may accumulate in the&#xD;
      external ear canal and cause discomfort to the patient, sensation ofobtuseness and conductive&#xD;
      hearing loss. Patients who use hearing aids may suffer from problems wearing them, and&#xD;
      sometimes the cerumen may plug the inner part of the hearing aid or the ventilation channel&#xD;
      of the ear phone.&#xD;
&#xD;
      For caregivers, cerumen may poses a diagnostic challenge, by concealing part of the external&#xD;
      ear canal and tympanic membrane, thus making it difficult to observe the middle ear. cerumen&#xD;
      my affect the results of audiometric tests, ABR tests, Otoacustic Emission tests and in&#xD;
      conducting tympanometric tests. All of which may result in false results. The incidence of&#xD;
      cerumen is estimated to be betwean 7 to 35% of the general population.&#xD;
&#xD;
      There are few options to evacuate the cerumen, but they usually require skill and the use of&#xD;
      otology microscope. It mays casue discomfort or pain, and even trauma to the external ear&#xD;
      canal or the tympanic membrane. A device which does not require a special skill or equipment&#xD;
      may have a advantage, especially for the general practioner doctor.&#xD;
&#xD;
      The Wondertip is an Israeli patent, made of silicone with a coil like end, targeted to&#xD;
      evacuate the cerumen in a safe and effective manner. The coil is gently inserted to the ear&#xD;
      canal, grasps and evacuates the cerumen.&#xD;
&#xD;
      The purpose of the trial is to investigate the safety and efficacy of the Wondertip. A second&#xD;
      purpose is to messure external ear canal depth.&#xD;
&#xD;
      Each candidate which will present with cerumen impaction will recieve a detailed explanation&#xD;
      regarding the trial. If the patient agrees, and signs a concent form, a short interview will&#xD;
      take place by the doctor. An evacuation of the cerumen will be attempted by the same doctor&#xD;
      with the Wondertip. Further the doctor will document details regarding the safety and&#xD;
      efficacy of the procedure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>February 2017</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">November 2017</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>view of the tympanic membrane</measure>
    <time_frame>10 minutes</time_frame>
    <description>how much of the tympanic is visible after using the Wondertip</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>External Ear Disorder</condition>
  <arm_group>
    <arm_group_label>Impacted cerumen</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>removing cerumen from external ears of patients with impacted cerumen, obscuring the canal and the tympanic membrane.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>removing cerumen from external ear (Wondertip)</intervention_name>
    <description>The wondertip will be coiled into the external ear canal with the purpose of grasping and evacuating the cerumen. Following the evacuation, the depth of the external ear canal will be messured.</description>
    <arm_group_label>Impacted cerumen</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients over 1 year old who have cerumen impaction.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  external ear infection&#xD;
&#xD;
          -  chronic otitis media with perforation of the tympanic membrane&#xD;
&#xD;
          -  past ear surgery&#xD;
&#xD;
          -  otorrhea&#xD;
&#xD;
          -  inflamation of the auricle or the periauricular region&#xD;
&#xD;
          -  temporal bone neoplasm&#xD;
&#xD;
          -  deafness in the contralateral ear (single sided deafness).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ehud Katzanel, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kaplan Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ehud Katzanel, Dr</last_name>
    <phone>972-8-9441649</phone>
    <email>udika@clalit.org.il</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Noam Bartov, Dr</last_name>
    <phone>972547895064</phone>
    <email>noam.bartov@clalit.org.il</email>
  </overall_contact_backup>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 10, 2017</study_first_submitted>
  <study_first_submitted_qc>January 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 12, 2017</study_first_posted>
  <last_update_submitted>January 11, 2017</last_update_submitted>
  <last_update_submitted_qc>January 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kaplan Medical Center</investigator_affiliation>
    <investigator_full_name>Dr Udi Katzanel</investigator_full_name>
    <investigator_title>head of otology and cochlear implant program</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ear Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>no plan of sharing IPD</ipd_description>
  </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/NCT03019380
org study id: 0125-16-KMC-CTIL
nct id: NCT03019380
lead sponsor: 
has dmc: Yes
Wondertip is a silicone single use device with a coil end, designed for the purpose of
      evacuating impacted cerumen of external ear canals. This trial aims at testing the safety and
      efficacy of this device. The participating investigators will be ENT doctors with the skill
      of examining the treating ear problems.
Cerumen is ear wax, a combination of dead skin cells of the external ear canal, sebaceous
      glands secretions and ceruminous sweat glands secretions. Cerumen exists in a range of people
      but sometimes it become an obstacle to patients or caregivers. Cerumen may accumulate in the
      external ear canal and cause discomfort to the patient, sensation ofobtuseness and conductive
      hearing loss. Patients who use hearing aids may suffer from problems wearing them, and
      sometimes the cerumen may plug the inner part of the hearing aid or the ventilation channel
      of the ear phone.

      For caregivers, cerumen may poses a diagnostic challenge, by concealing part of the external
      ear canal and tympanic membrane, thus making it difficult to observe the middle ear. cerumen
      my affect the results of audiometric tests, ABR tests, Otoacustic Emission tests and in
      conducting tympanometric tests. All of which may result in false results. The incidence of
      cerumen is estimated to be betwean 7 to 35% of the general population.

      There are few options to evacuate the cerumen, but they usually require skill and the use of
      otology microscope. It mays casue discomfort or pain, and even trauma to the external ear
      canal or the tympanic membrane. A device which does not require a special skill or equipment
      may have a advantage, especially for the general practioner doctor.

      The Wondertip is an Israeli patent, made of silicone with a coil like end, targeted to
      evacuate the cerumen in a safe and effective manner. The coil is gently inserted to the ear
      canal, grasps and evacuates the cerumen.

      The purpose of the trial is to investigate the safety and efficacy of the Wondertip. A second
      purpose is to messure external ear canal depth.

      Each candidate which will present with cerumen impaction will recieve a detailed explanation
      regarding the trial. If the patient agrees, and signs a concent form, a short interview will
      take place by the doctor. An evacuation of the cerumen will be attempted by the same doctor
      with the Wondertip. Further the doctor will document details regarding the safety and
      efficacy of the procedure.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: view of the tympanic membrane
time frame: 10 minutes
description: how much of the tympanic is visible after using the Wondertip
arm group label: Impacted cerumen
arm group type: Experimental
description: removing cerumen from external ears of patients with impacted cerumen, obscuring the canal and the tympanic membrane.
intervention type: Device
intervention name: removing cerumen from external ear (Wondertip)
description: The wondertip will be coiled into the external ear canal with the purpose of grasping and evacuating the cerumen. Following the evacuation, the depth of the external ear canal will be messured.
arm group label: Impacted cerumen
criteria: 
gender: All
minimum age: 1 Year
maximum age: N/A
healthy volunteers: No
last name: Ehud Katzanel, Dr
role: Principal Investigator
affiliation: Kaplan Medical Center
last name: Ehud Katzanel, Dr
phone: 972-8-9441649
email: udika@clalit.org.il
last name: Noam Bartov, Dr
phone: 972547895064
email: noam.bartov@clalit.org.il
responsible party type: Principal Investigator
investigator affiliation: Kaplan Medical Center
investigator full name: Dr Udi Katzanel
investigator title: head of otology and cochlear implant program
mesh term: Ear Diseases
sharing ipd: No
ipd description: no plan of sharing IPD