Device Study to Evaluate the Detection and Characterizati... | NCT01421199

Studies
Device Study to Evaluate the Detection and Characterization of Middle Ear Fluid in Children

NCT01421199

Sponsor

OtoSonics Inc.

Status

Unknown status

Last Update Posted

Aug 22, 2011Estimated

Enrollment

125Estimated

Phase

Not Applicable

Conditions

Otitis Media With Effusion
Middle Ear Effusion

Interventions

Myringotomy

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

Aug 2011

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

Sep 2011

Primary Completion Date

Dec 2011Estimated

Completion Date

Dec 2011Estimated

First Submitted Date

Aug 18, 2011

First Submission Date that Met QC Criteria

Aug 19, 2011

First Posted Date

Aug 22, 2011Estimated

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

Aug 19, 2011

Last Update Posted Date

Aug 22, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

The study has three objectives:

To determine if the device can detect if middle ear fluid is present in children who are scheduled for tube placement (myringotomy)
If fluid is present to characterize the fluid as thick or thin
Evaluate the safety 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

125Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Myringotomy	Other	On arm	Procedure: Myringotomy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Myringotomy	Procedure	tube placement for children with multiple ear infections	Myringotomy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
detection of middle ear fluid	device will be used during myringotomy procedure to detect middle ear fluid	day one

Secondary Outcomes

Measure	Description	Time Frame
fluid viscosity	fluid obtained during myringotomy will be tested for viscosity	day one

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

6 months to 17 years
scheduled to undergo myringotomy procedure

Exclusion Criteria:

mastoiditis
tympanostomy tubes
chronic middle ear disease
otitis externa
perforations of the middle ear
use of antibiotic ear drops within 2 days of surgery
systemic antibiotic use

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Months

Maximum Age

17 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mark E Boseley, MD	Contact	253.968.1430
Shaun Nguyen, MD	Contact	843.792.1356

Overall Officials

Name	Affiliation	Role
Mark E Boseley, MD	Madigan Army Medical Center	Principal Investigator

Locations

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