NCT03978195

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2019

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 3, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 7, 2019

Completed
24 days until next milestone

Study Start

First participant enrolled

July 1, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

June 7, 2019

Status Verified

June 1, 2019

Enrollment Period

2.1 years

First QC Date

June 3, 2019

Last Update Submit

June 5, 2019

Conditions

Otitis Media With Effusion

Outcome Measures

Primary Outcomes (2)

  • Middle ear values of Tympanometry

    Values will be compared to baseline values of Tympanometry

    10 weeks

  • Middle ear ventilation evaluated by otoscopy

    Otoscopy evaluation of ear ventilation will be compared to baseline values

    10 weeks

Secondary Outcomes (1)

  • Auditory test

    10 weeks

Study Arms (2)

Treatment

EXPERIMENTAL
Device: Non-invasive device for middle ear ventilation

Control

NO INTERVENTION

Interventions

Non-invasive device for middle ear ventilationDEVICE

Daily use of the device

Treatment

Eligibility Criteria

Age4 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Otitis Media with Effusion

Interventions

Middle Ear Ventilation

Condition Hierarchy (Ancestors)

Otitis MediaOtitisEar DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

OstomySurgical Procedures, OperativeOtologic Surgical ProceduresOtorhinolaryngologic Surgical Procedures

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2019

First Posted

June 7, 2019

Study Start

July 1, 2019

Primary Completion

August 1, 2021

Study Completion

November 1, 2021

Last Updated

June 7, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share