Otitis Media With EffusionNCT01421199
Device Study to Evaluate the Detection and Characterization of Middle Ear Fluid in Children
A study testing Myringotomy in people with Otitis Media With Effusion and Middle Ear Effusion, run by OtoSonics Inc..
Trial 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 Read more about this study
- Who is it for?
- Ages 6 months to 17 years
- Conditions the study is for
- Otitis Media With Effusion, Middle Ear Effusion
- What is being tested?
- Myringotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- No sites listed yet
- Study dates
- Sep 2011to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 6 months to 17 years
- scheduled to undergo myringotomy procedure
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
Mark E Boseley, MD contact
Shaun Nguyen, MD contact
About this study
Official title: A Prospective, Multi Center, Non-randomized Clinical Trial to Evaluate the Ear Effusion Detection and Characterization System (EEDCS) to Detect and Characterize Middle Ear Fluid in Children
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
- Conditions
- Otitis Media With Effusion, Middle Ear Effusion
- Being tested
- Myringotomy
- Keywords
- Otitis Media with Effusion, Middle Ear Effusion
- Medical subject headings
- Otitis Media with Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyringotomyProcedure or surgery
Also called ear tubes
tube placement for children with multiple ear infections
| Study group | Role | What they receive |
|---|---|---|
| Myringotomy | Other | On arm Receives: Procedure: Myringotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
detection of middle ear fluid
device will be used during myringotomy procedure to detect middle ear fluid
Measured: day one
Secondary outcomes (1)
fluid viscosity
fluid obtained during myringotomy will be tested for viscosity
Measured: day one
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2011 (estimated)
- Study startSep 2011
- Primary completionDec 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Otitis Media With EffusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OtoSonics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mark E Boseley, MD, Principal investigator, Madigan Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01421199
- Sponsor's protocol ID
- OTO-Myr
- Status last verified
- Aug 2011
- First submitted
- 18 Aug 2011
- Last updated
- 22 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi Center, Non-randomized Clinical Trial to Evaluate the Ear Effusion Detection and Characterization System (EEDCS) to Detect and Characterize Middle Ear Fluid in Children
- ClinicalTrials.gov ID
- NCT01421199
- Acronym / sponsor ID
- OTO-Myr
- Conditions
- Otitis Media With Effusion, Middle Ear Effusion
- Keywords
- Otitis Media with Effusion, Middle Ear Effusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- OtoSonics Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2011
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 22 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Myringotomy | Other | Procedure: MyringotomyOn arm |
Who may qualify
- Ages
- 6 months to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 6 months to 17 years
- scheduled to undergo myringotomy procedure
Key exclusion criteria (7 listed)
- mastoiditis
- tympanostomy tubes
- chronic middle ear disease
- otitis externa
- perforations of the middle ear
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MyringotomyAlso: ear tubestube placement for children with multiple ear infections | Procedure or surgery | Myringotomy |
Primary outcome
detection of middle ear fluid
Time frame: day one
device will be used during myringotomy procedure to detect middle ear fluid
1 secondary outcome
fluid viscosity
Time frame: day one
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark E Boseley, MD contact
Shaun Nguyen, MD contact
Mark E Boseley, MD principal investigator
Madigan Army Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Myringotomy in people with Otitis Media With Effusion and Middle Ear Effusion, run by OtoSonics Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mark E Boseley, MD (253.968.1430), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
detection of middle ear fluid (time frame: day one). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2011.