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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03019380
Recruitment Status : Unknown
Verified January 2017 by Dr Udi Katzanel, Kaplan Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : January 12, 2017
Last Update Posted : January 12, 2017
Sponsor:
Information provided by (Responsible Party):
Dr Udi Katzanel, Kaplan Medical Center

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.

Condition or disease Intervention/treatment Phase
External Ear Disorder Device: removing cerumen from external ear (Wondertip) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Testing the Effectivness and Safety of the Wondertip
Study Start Date : February 2017
Estimated Primary Completion Date : November 2017
Estimated Study Completion Date : December 2017

Arm Intervention/treatment
Experimental: Impacted cerumen
removing cerumen from external ears of patients with impacted cerumen, obscuring the canal and the tympanic membrane.
Device: removing cerumen from external ear (Wondertip)
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 Measures :
  1. view of the tympanic membrane [ Time Frame: 10 minutes ]
    how much of the tympanic is visible after using the Wondertip



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03019380


Contacts
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Contact: Ehud Katzanel, Dr 972-8-9441649 udika@clalit.org.il
Contact: Noam Bartov, Dr 972547895064 noam.bartov@clalit.org.il

Sponsors and Collaborators
Kaplan Medical Center
Investigators
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Principal Investigator: Ehud Katzanel, Dr Kaplan Medical Center
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Responsible Party: Dr Udi Katzanel, head of otology and cochlear implant program, Kaplan Medical Center
ClinicalTrials.gov Identifier: NCT03019380    
Other Study ID Numbers: 0125-16-KMC-CTIL
First Posted: January 12, 2017    Key Record Dates
Last Update Posted: January 12, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: no plan of sharing IPD
Additional relevant MeSH terms:
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Ear Diseases
Otorhinolaryngologic Diseases