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
About this trial
This is an interventional treatment trial for External Ear Disorder
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).
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
NCT ID
NCT03019380
First Posted
January 10, 2017
Last Updated
January 11, 2017
Sponsor
Kaplan Medical Center
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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