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

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ClinicalTrials.gov Identifier: NCT03978195
Recruitment Status : Not yet recruiting
First Posted : June 7, 2019
Last Update Posted : June 7, 2019
Sponsor:
Information provided by (Responsible Party):
Yuinvent Innovations Ltd.

Brief 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.


Condition or disease Intervention/treatment Phase
Otitis Media With Effusion Device: Non-invasive device for middle ear ventilation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: EMD - A Non-invasive Device for Ventilating the Middle Ear Feasibility Study to Evaluate Efficiency and User Satisfaction
Estimated Study Start Date : July 1, 2019
Estimated Primary Completion Date : August 1, 2021
Estimated Study Completion Date : November 1, 2021

Arm Intervention/treatment
Experimental: Treatment Device: Non-invasive device for middle ear ventilation
Daily use of the device

No Intervention: Control



Primary Outcome Measures :
  1. Middle ear values of Tympanometry [ Time Frame: 10 weeks ]
    Values will be compared to baseline values of Tympanometry

  2. Middle ear ventilation evaluated by otoscopy [ Time Frame: 10 weeks ]
    Otoscopy evaluation of ear ventilation will be compared to baseline values


Secondary Outcome Measures :
  1. Auditory test [ Time Frame: 10 weeks ]
    Values will be compared to baseline values of Auditory test



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Ages Eligible for Study:   4 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  • 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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Responsible Party: Yuinvent Innovations Ltd.
ClinicalTrials.gov Identifier: NCT03978195     History of Changes
Other Study ID Numbers: 0275-18-MMC (CLEAR OM R1)
First Posted: June 7, 2019    Key Record Dates
Last Update Posted: June 7, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Additional relevant MeSH terms:
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Otitis Media
Otitis Media with Effusion
Otitis
Ear Diseases
Otorhinolaryngologic Diseases