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Status unknownNCT01421199Updated Aug 22, 2011

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

An interventional study of Myringotomy in Otitis Media With Effusion and Middle Ear Effusion, sponsored by OtoSonics Inc.. Status unknown. Open to participants aged 6 Months to 17 Years. Per ClinicalTrials.gov, last updated 2011-08-22.

Sponsored by OtoSonics Inc. · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Aug 2011), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
125
Allocation
Non-randomized
Ages
6 Months to 17 Years
Sex
All
01

Study summary

The study has three objectives:

  1. To determine if the device can detect if middle ear fluid is present in children who are scheduled for tube placement (myringotomy)
  2. If fluid is present to characterize the fluid as thick or thin
  3. Evaluate the safety of the device
02

Conditions studied

  • Otitis Media With Effusion
  • Middle Ear Effusion

Keywords

  • Otitis Media with Effusion
  • Middle Ear Effusion
03

In context

Otitis

246 studies on the registry are indexed under Otitis; 21 are open to participants now.

This study's planned enrollment of 125 is close to the median of 126 across 173 interventional studies indexed under Otitis.

Browse Otitis studies →

Lead sponsor

This is the only study on the registry with OtoSonics Inc. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 6 months to 17 years
  • scheduled to undergo myringotomy procedure

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Single group
Masking
Single (Investigator)
Enrollment
125 participants (estimated)

Study arms

  • Other
    Myringotomy

    On arm

    Procedure: Myringotomy

Interventions

  • ProcedureMyringotomy

    tube placement for children with multiple ear infections

    Also known as: ear tubes

06

What researchers measure

Primary outcomes

  1. detection of middle ear fluid

    device will be used during myringotomy procedure to detect middle ear fluid

    Time frame: day one

Secondary outcomes

  1. fluid viscosity

    fluid obtained during myringotomy will be tested for viscosity

    Time frame: day one

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 22, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01421199
Lead sponsor
OtoSonics Inc.
Responsible party
Sponsor
First posted
Aug 22, 2011
Start date
Sep 2011
Primary completion
Dec 2011 (estimated)
Completion
Dec 2011 (estimated)
Last update
Aug 22, 2011

Study contacts

Mark E Boseley, MD
Contact
253.968.1430
Shaun Nguyen, MD
Contact
843.792.1356
Mark E Boseley, MD
principal investigator · Madigan Army Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2011. You cannot join it, but the record below documents what was studied.

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