Otitis Media With EffusionNCT03978195
A Non-invasive Device to Remove Fluid From the Middle Ear
A study testing Non-invasive device for middle ear ventilation in people with Otitis Media With Effusion, run by Yuinvent Innovations Ltd..
Trial summary
A feasibility study for evaluating efficacy and satisfaction is treated using a non-invasive device for middle ear ventilation. The study is designed to test the device's effectiveness by encouraging the evacuation of fluid from the middle ear, aid in hearing improvement, pain relief and assessment of patient… Read more about this study
- Who is it for?
- Ages 4 to 10 years
- Conditions the study is for
- Otitis Media With Effusion
- What is being tested?
- Non-invasive device for middle ear ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2019to 1 Nov 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 4 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosed with ear fluids (OME) according to a doctor's examination for at least 4-6 weeks. There is a progressive hearing impairment and a matching tympanum.
- In principle, these children (with OME and hearing impairment) meet the criteria and candidates for the analysis of inserting tubes of incontinence (buttons).
Who cannot join
- First encounter: acute ear infection or Proper Otoscopy
- Second session: First review: Otoscopy / Timpneometry / Hearing test.
- Parallel treatment: acupuncture - tubes insertion - discontinuation of follow-up - cessation of the experiment initiated by parents
About this study
Official title: EMD - A Non-invasive Device for Ventilating the Middle Ear Feasibility Study to Evaluate Efficiency and User Satisfaction
A feasibility study for evaluating efficacy and satisfaction is treated using a non-invasive device for middle ear ventilation.
The study is designed to test the device's effectiveness by encouraging the evacuation of fluid from the middle ear, aid in hearing improvement, pain relief and assessment of patient satisfaction with the use of the device.
- Conditions
- Otitis Media With Effusion
- Being tested
- Non-invasive device for middle ear ventilation
- Medical subject headings
- Otitis Media with Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive device for middle ear ventilationDevice
Daily use of the device
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Not described Receives: Device: Non-invasive device for middle ear ventilation |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Middle ear values of Tympanometry
Values will be compared to baseline values of Tympanometry
Measured: 10 weeks
Middle ear ventilation evaluated by otoscopy
Otoscopy evaluation of ear ventilation will be compared to baseline values
Measured: 10 weeks
Secondary outcomes (1)
Auditory test
Values will be compared to baseline values of Auditory test
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2019
- Study start1 Jul 2019 (estimated)
- Primary completion1 Aug 2021 (estimated)
- Study completion1 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Otitis Media With EffusionStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yuinvent Innovations Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03978195
- Sponsor's protocol ID
- 0275-18-MMC (CLEAR OM R1)
- Status last verified
- Jun 2019
- First submitted
- 3 Jun 2019
- Last updated
- 7 Jun 2019
- Results posted
- 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 7 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EMD - A Non-invasive Device for Ventilating the Middle Ear Feasibility Study to Evaluate Efficiency and User Satisfaction
- ClinicalTrials.gov ID
- NCT03978195
- Acronym / sponsor ID
- 0275-18-MMC (CLEAR OM R1)
- Conditions
- Otitis Media With Effusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Yuinvent Innovations Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Jul 2019 (estimated)
- Primary completion
- 1 Aug 2021 (estimated)
- Study completion
- 1 Nov 2021 (estimated)
- First posted
- 7 Jun 2019 (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.
A feasibility study for evaluating efficacy and satisfaction is treated using a non-invasive device for middle ear ventilation.
The study is designed to test the device's effectiveness by encouraging the evacuation of fluid from the middle ear, aid in hearing improvement, pain relief and assessment of patient satisfaction with the use of the device.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Non-invasive device for middle ear ventilation |
| Control | No intervention | – |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Diagnosed with ear fluids (OME) according to a doctor's examination for at least 4-6 weeks. There is a progressive hearing impairment and a matching tympanum.
- In principle, these children (with OME and hearing impairment) meet the criteria and candidates for the analysis of inserting tubes of incontinence (buttons).
Key exclusion criteria (3 listed)
- First encounter: acute ear infection or Proper Otoscopy
- Second session: First review: Otoscopy / Timpneometry / Hearing test.
- Parallel treatment: acupuncture - tubes insertion - discontinuation of follow-up - cessation of the experiment initiated by parents
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 |
|---|---|---|
| Non-invasive device for middle ear ventilationDaily use of the device | Device | Treatment |
Primary outcome
Middle ear values of Tympanometry
Time frame: 10 weeks
Values will be compared to baseline values of Tympanometry
Middle ear ventilation evaluated by otoscopy
Time frame: 10 weeks
Otoscopy evaluation of ear ventilation will be compared to baseline values
1 secondary outcome
Auditory test
Time frame: 10 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive device for middle ear ventilation in people with Otitis Media With Effusion, run by Yuinvent Innovations Ltd..
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: status not confirmed, as of the sponsor's last update on 7 Jun 2019. 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?
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?
Middle ear values of Tympanometry (time frame: 10 weeks). 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 7 Jun 2019; AzTrials last refreshed its copy on 27 Oct 2026.