External Ear DisorderNCT03019380
A Clinical Trial to Test the Saftey and Success Rate for a Cerrumen Cleaning Device - "Wondertip".
A study testing removing cerumen from external ear (Wondertip) in people with External Ear Disorder, run by Kaplan Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- External Ear Disorder
- What is being tested?
- removing cerumen from external ear (Wondertip)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Feb 2017to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients over 1 year old who have cerumen impaction.
Who cannot join
- 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).
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Testing the Effectivness and Safety of the Wondertip
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.
Read the 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.
- Conditions
- External Ear Disorder
- Being tested
- removing cerumen from external ear (Wondertip)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
removing cerumen from external ear (Wondertip)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Impacted cerumen | Experimental | removing cerumen from external ears of patients with impacted cerumen, obscuring the canal and the tympanic membrane. Receives: Device: removing cerumen from external ear (Wondertip) |
What is being measured
The primary outcome is the main question the study is designed to answer.
view of the tympanic membrane
how much of the tympanic is visible after using the Wondertip
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2017 (estimated)
- Study startFeb 2017
- Primary completionNov 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for External Ear DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaplan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Udi Katzanel, Kaplan Medical Center
- Investigators
- Ehud Katzanel, Dr, Principal investigator, Kaplan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03019380
- Sponsor's protocol ID
- 0125-16-KMC-CTIL
- Status last verified
- Jan 2017
- First submitted
- 10 Jan 2017
- Last updated
- 12 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: no plan of sharing IPD
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Effectivness and Safety of the Wondertip
- ClinicalTrials.gov ID
- NCT03019380
- Acronym / sponsor ID
- 0125-16-KMC-CTIL
- Conditions
- External Ear Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Kaplan Medical CenterUniversity, hospital or other
- Study start
- Feb 2017
- Primary completion
- Nov 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 12 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Impacted cerumen | Experimental | Device: removing cerumen from external ear (Wondertip)removing cerumen from external ears of patients with impacted cerumen, obscuring the canal and the tympanic membrane. |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients over 1 year old who have cerumen impaction.
Key exclusion criteria (7 listed)
- external ear infection
- chronic otitis media with perforation of the tympanic membrane
- past ear surgery
- otorrhea
- inflamation of the auricle or the periauricular region
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Impacted cerumen |
Primary outcome
view of the tympanic membrane
Time frame: 10 minutes
how much of the tympanic is visible after using the Wondertip
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2017.
- Individual participant dataSharing planned: No. no plan of sharing IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ehud Katzanel, Dr principal investigator
Kaplan Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing removing cerumen from external ear (Wondertip) in people with External Ear Disorder, run by Kaplan Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ehud Katzanel, Dr (972-8-9441649, udika@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
view of the tympanic membrane (time frame: 10 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2017.