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

June 5, 2019 updated by: Yuinvent Innovations Ltd.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 10 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Control
EXPERIMENTAL: Treatment
Device: Non-invasive device for middle ear ventilation
Daily use of the device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Middle ear values of Tympanometry
Time Frame: 10 weeks
Values will be compared to baseline values of Tympanometry
10 weeks
Middle ear ventilation evaluated by otoscopy
Time Frame: 10 weeks
Otoscopy evaluation of ear ventilation will be compared to baseline values
10 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Auditory test
Time Frame: 10 weeks
Values will be compared to baseline values of Auditory test
10 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yuinvent Innovations Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

July 1, 2019

Primary Completion (ANTICIPATED)

August 1, 2021

Study Completion (ANTICIPATED)

November 1, 2021

Study Registration Dates

First Submitted

June 3, 2019

First Submitted That Met QC Criteria

June 5, 2019

First Posted (ACTUAL)

June 7, 2019

Study Record Updates

Last Update Posted (ACTUAL)

June 7, 2019

Last Update Submitted That Met QC Criteria

June 5, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0275-18-MMC (CLEAR OM R1)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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