Device Study to Evaluate the Detection and Characterization of Middle Ear Fluid in Children
This study is not yet open for participant recruitment.
Verified August 2011 by OtoSonics Inc.
Sponsor:
OtoSonics Inc.
Information provided by (Responsible Party):
OtoSonics Inc.
ClinicalTrials.gov Identifier:
NCT01421199
First received: August 18, 2011
Last updated: August 19, 2011
Last verified: August 2011
| Tracking Information | |||||||||
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| First Received Date ICMJE | August 18, 2011 | ||||||||
| Last Updated Date | August 19, 2011 | ||||||||
| Start Date ICMJE | September 2011 | ||||||||
| Estimated Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
detection of middle ear fluid [ Time Frame: day one ] [ Designated as safety issue: No ] device will be used during myringotomy procedure to detect middle ear fluid |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01421199 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
fluid viscosity [ Time Frame: day one ] [ Designated as safety issue: No ] fluid obtained during myringotomy will be tested for viscosity |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Device Study to Evaluate the Detection and Characterization of Middle Ear Fluid in Children | ||||||||
| Official Title ICMJE | 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 | ||||||||
| Brief Summary | The study has three objectives:
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Single Blind (Investigator) Primary Purpose: Diagnostic |
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| Condition ICMJE |
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| Intervention ICMJE | Procedure: Myringotomy
tube placement for children with multiple ear infections
Other Name: ear tubes |
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| Study Arm (s) | Myringotomy
On arm
Intervention: Procedure: Myringotomy |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||||
| Estimated Enrollment ICMJE | 125 | ||||||||
| Estimated Completion Date | December 2011 | ||||||||
| Estimated Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 6 Months to 17 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Not Provided | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01421199 | ||||||||
| Other Study ID Numbers ICMJE | OTO-Myr | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | OtoSonics Inc. | ||||||||
| Study Sponsor ICMJE | OtoSonics Inc. | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | OtoSonics Inc. | ||||||||
| Verification Date | August 2011 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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