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Status unknownNCT03978195Updated Jun 7, 2019

A Non-invasive Device to Remove Fluid From the Middle Ear

An interventional study of Non-invasive device for middle ear ventilation in Otitis Media With Effusion, sponsored by Yuinvent Innovations Ltd.. Status unknown. Open to participants aged 4 Years to 10 Years. Per ClinicalTrials.gov, last updated 2019-06-07.

Sponsored by Yuinvent Innovations Ltd. · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Non-randomized
Ages
4 Years to 10 Years
Sex
All
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Study 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 satisfaction with the use of the device.

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Conditions studied

  • Otitis Media With Effusion
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In context

Otitis Media

284 studies on the registry are indexed under Otitis Media; 33 are open to participants now.

This study's planned enrollment of 40 is below the median of 126 across 194 interventional studies indexed under Otitis Media.

Browse Otitis Media studies →

Lead sponsor

Yuinvent Innovations Ltd. is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
4 Years to 10 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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).

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Treatment

    Device: Non-invasive device for middle ear ventilation

  • No intervention
    Control

Interventions

  • DeviceNon-invasive device for middle ear ventilation

    Daily use of the device

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What researchers measure

Primary outcomes

  1. Middle ear values of Tympanometry

    Values will be compared to baseline values of Tympanometry

    Time frame: 10 weeks

  2. Middle ear ventilation evaluated by otoscopy

    Otoscopy evaluation of ear ventilation will be compared to baseline values

    Time frame: 10 weeks

Secondary outcomes

  1. Auditory test

    Values will be compared to baseline values of Auditory test

    Time frame: 10 weeks

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 7, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03978195
Lead sponsor
Yuinvent Innovations Ltd.
Responsible party
Sponsor
First posted
Jun 7, 2019
Start date
Jul 1, 2019 (estimated)
Primary completion
Aug 1, 2021 (estimated)
Completion
Nov 1, 2021 (estimated)
Last update
Jun 7, 2019

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.

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Discussion

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