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A Clinical Trial to Test the Saftey and Success Rate for a Cerrumen Cleaning Device - "Wondertip".

Primary Purpose

External Ear Disorder

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
removing cerumen from external ear (Wondertip)
Sponsored by
Kaplan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for External Ear Disorder

Eligibility Criteria

1 Year - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients over 1 year old who have cerumen impaction.

Exclusion Criteria:

  • external ear infection
  • chronic otitis media with perforation of the tympanic membrane
  • past ear surgery
  • otorrhea
  • inflamation of the auricle or the periauricular region
  • temporal bone neoplasm
  • deafness in the contralateral ear (single sided deafness).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Impacted cerumen

    Arm Description

    removing cerumen from external ears of patients with impacted cerumen, obscuring the canal and the tympanic membrane.

    Outcomes

    Primary Outcome Measures

    view of the tympanic membrane
    how much of the tympanic is visible after using the Wondertip

    Secondary Outcome Measures

    Full Information

    First Posted
    January 10, 2017
    Last Updated
    January 11, 2017
    Sponsor
    Kaplan Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03019380
    Brief Title
    A Clinical Trial to Test the Saftey and Success Rate for a Cerrumen Cleaning Device - "Wondertip".
    Official Title
    Testing the Effectivness and Safety of the Wondertip
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 2017 (undefined)
    Primary Completion Date
    November 2017 (Anticipated)
    Study Completion Date
    December 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Kaplan Medical Center

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    External Ear Disorder

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Impacted cerumen
    Arm Type
    Experimental
    Arm Description
    removing cerumen from external ears of patients with impacted cerumen, obscuring the canal and the tympanic membrane.
    Intervention Type
    Device
    Intervention Name(s)
    removing cerumen from external ear (Wondertip)
    Intervention 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.
    Primary Outcome Measure Information:
    Title
    view of the tympanic membrane
    Description
    how much of the tympanic is visible after using the Wondertip
    Time Frame
    10 minutes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    1 Year
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients over 1 year old who have cerumen impaction. Exclusion Criteria: external ear infection chronic otitis media with perforation of the tympanic membrane past ear surgery otorrhea inflamation of the auricle or the periauricular region temporal bone neoplasm deafness in the contralateral ear (single sided deafness).
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ehud Katzanel, Dr
    Phone
    972-8-9441649
    Email
    udika@clalit.org.il
    First Name & Middle Initial & Last Name or Official Title & Degree
    Noam Bartov, Dr
    Phone
    972547895064
    Email
    noam.bartov@clalit.org.il
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ehud Katzanel, Dr
    Organizational Affiliation
    Kaplan Medical Center
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    no plan of sharing IPD

    Learn more about this trial

    A Clinical Trial to Test the Saftey and Success Rate for a Cerrumen Cleaning Device - "Wondertip".

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