Cerumen Impaction of Both EarsNCT04743817
Feasibility Evaluation of OtoSet
A study testing OtoSet - Ear Cleaning System in people with Cerumen Impaction of Both Ears, run by SafKan at 2 sites in United States.
Trial summary
This is a single center study. 100 ears are planned (up to 100 patients). Each subject will have one or both ears cleaned with OtoSet. The subject's level of earwax will be evaluated before and after by an evaluator. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerumen Impaction of Both Ears
- What is being tested?
- OtoSet - Ear Cleaning System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 2 sitesUnited States
- Study dates
- 31 Mar 2021to 21 Oct 2021
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mild (1), Moderate (2), or Complete (3) occlusion of the ear canal based on the Degree of Occlusion Scale in one or both ears
- Informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study
Who cannot join
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient of the quality of data
- Subject has life threatening illness
- Subject has immune deficiency
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Rainier Clinical Research Center
Renton, Washington, 98057
Eclipse Clinical Research
Tucson, Arizona, 85745
About this study
Official title: Feasibility Evaluation of the OtoSet - Ear Cleaning System
This is a single center study. 100 ears are planned (up to 100 patients). Each subject will have one or both ears cleaned with OtoSet. The subject's level of earwax will be evaluated before and after by an evaluator.
Read the detailed description
This is a single center study. 100 ears are planned (up to 100 patients). Each subject will have one or both ears cleaned with OtoSet. The subject's level of earwax will be evaluated before and after by an evaluator.
Screening data will be reviewed to determine subject eligibility. Subjects who meet all inclusion criteria and none of the exclusion criteria will be entered into the study.
Total duration of subject participation will be 1 day with a follow up call within 2-4 days after the procedure. Total duration of the study is expected to be 3 months.
- Conditions
- Cerumen Impaction of Both Ears
- Being tested
- OtoSet - Ear Cleaning System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OtoSet - Ear Cleaning SystemDevice
Up to five (5) cleaning cycles using the OtoSet - Ear Cleaning System
| Study group | Role | What they receive |
|---|---|---|
| OtoSet - Ear Cleaning Sytem | Experimental | Not described Receives: Device: OtoSet - Ear Cleaning System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy as Assessed by Occlusion Scale
Improvement of 1.0 on the Degree of Occlusion Scale (4 point scale) pre- and post-procedure evaluation (score 0 = no occlusion; 3 = complete occlusion)
Measured: Treatment Visit (Day 1) (pre- to post-procedure)
Safety as Assessed by Adverse Events
Incidence of adverse events with severity defined using the National Cancer Institute's Common Terminology Criteria for Adverse Events (4 point scale) (1 = mild; 4 = life-threatening)
Measured: Treatment Visit (Day 1) through follow-up call (Day 2-4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2021
- Study start31 Mar 2021
- Primary completion21 Oct 2021
- Study completion21 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerumen Impaction of Both EarsStudies 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
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- SafKan
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Felice Anderson, Principal investigator, Eclipse Clinical ResearchRonald Brazg, MD, FACE, Principal investigator, Rainier Clinical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04743817
- Sponsor's protocol ID
- SK-0119
- Status last verified
- May 2022
- First submitted
- 3 Feb 2021
- Last updated
- 12 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Evaluation of the OtoSet - Ear Cleaning System
- ClinicalTrials.gov ID
- NCT04743817
- Acronym / sponsor ID
- SK-0119
- Conditions
- Cerumen Impaction of Both Ears
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- SafKanIndustry (pharma, biotech, devices)
- Study start
- 31 Mar 2021 (actual)
- Primary completion
- 21 Oct 2021 (actual)
- Study completion
- 21 Oct 2021 (actual)
- First posted
- 8 Feb 2021 (actual)
- 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.
This is a single center study. 100 ears are planned (up to 100 patients). Each subject will have one or both ears cleaned with OtoSet. The subject's level of earwax will be evaluated before and after by an evaluator.
Detailed description
This is a single center study. 100 ears are planned (up to 100 patients). Each subject will have one or both ears cleaned with OtoSet. The subject's level of earwax will be evaluated before and after by an evaluator.
Screening data will be reviewed to determine subject eligibility. Subjects who meet all inclusion criteria and none of the exclusion criteria will be entered into the study.
Total duration of subject participation will be 1 day with a follow up call within 2-4 days after the procedure. Total duration of the study is expected to be 3 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OtoSet - Ear Cleaning Sytem | Experimental | Device: OtoSet - Ear Cleaning System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Mild (1), Moderate (2), or Complete (3) occlusion of the ear canal based on the Degree of Occlusion Scale in one or both ears
- Informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study
Key exclusion criteria (3 listed)
- Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient of the quality of data
- Subject has life threatening illness
- Subject has immune deficiency
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 |
|---|---|---|
| OtoSet - Ear Cleaning SystemUp to five (5) cleaning cycles using the OtoSet - Ear Cleaning System | Device | OtoSet - Ear Cleaning Sytem |
Primary outcome
Efficacy as Assessed by Occlusion Scale
Time frame: Treatment Visit (Day 1) (pre- to post-procedure)
Improvement of 1.0 on the Degree of Occlusion Scale (4 point scale) pre- and post-procedure evaluation (score 0 = no occlusion; 3 = complete occlusion)
Safety as Assessed by Adverse Events
Time frame: Treatment Visit (Day 1) through follow-up call (Day 2-4)
Incidence of adverse events with severity defined using the National Cancer Institute's Common Terminology Criteria for Adverse Events (4 point scale) (1 = mild; 4 = life-threatening)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2022.
- Individual participant dataSharing planned: No
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.
Felice Anderson principal investigator
Eclipse Clinical Research
Ronald Brazg, MD, FACE principal investigator
Rainier Clinical Research Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OtoSet - Ear Cleaning System in people with Cerumen Impaction of Both Ears, run by SafKan at 2 sites in United States.
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 2 inclusion and 3 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: finished, as of the sponsor's last update on 12 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy as Assessed by Occlusion Scale (time frame: Treatment Visit (Day 1) (pre- to post-procedure)). The study lists 2 primary outcomes in all. 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 May 2022.