A Non-invasive Device to Remove Fluid From the Middle Ear | NCT03978195

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

NCT03978195

Sponsor

Yuinvent Innovations Ltd.

Status

Unknown status

Last Update Posted

Jun 7, 2019Actual

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Otitis Media With Effusion

Interventions

Non-invasive device for middle ear ventilation

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2019Estimated

Primary Completion Date

Aug 1, 2021Estimated

Completion Date

Nov 1, 2021Estimated

First Submitted Date

Jun 3, 2019

First Submission Date that Met QC Criteria

Jun 5, 2019

First Posted Date

Jun 7, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 5, 2019

Last Update Posted Date

Jun 7, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment	Experimental		Device: Non-invasive device for middle ear ventilation
Control	No Intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Non-invasive device for middle ear ventilation	Device	Daily use of the device	Treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Years

Maximum Age

10 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010034	Otitis Media with Effusion

Ancestor Terms

ID	Term
D010033	Otitis Media
D010031	Otitis
D004427	Ear Diseases
D010038	Otorhinolaryngologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008876	Middle Ear Ventilation

Ancestor Terms

ID	Term
D010030	Ostomy
D013514	Surgical Procedures, Operative
D013506	Otologic Surgical Procedures
D013517	Otorhinolaryngologic Surgical Procedures

Browse Leaves

Not provided

Browse Branches

Not provided