Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
27 participants
INTERVENTIONAL
2021-02-09
2024-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Solo+ Tympanostomy Tube Device
The Solo+ Tympanostomy Tube Device is a disposable surgical tool designed to deliver a tympanostomy tube (grommet) into the tympanic membrane of patients undergoing a tympanostomy tube placement procedure
Solo+ Tympanostomy Tube Device
The Solo+ Tympanostomy Tube Device is intended to deliver a tympanostomy tube through the tympanic membrane of a patient during a tympanostomy procedure
Interventions
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Solo+ Tympanostomy Tube Device
The Solo+ Tympanostomy Tube Device is intended to deliver a tympanostomy tube through the tympanic membrane of a patient during a tympanostomy procedure
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Narrow ear canals
* Anatomy that precludes safe access to both the left and right eardrum
* Membrane \>25% sclerosis
* Congenital or craniofacial abnormalities
* No available baseline audiometry and tympanometry
6 Months
15 Years
ALL
No
Sponsors
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AventaMed DAC
INDUSTRY
Responsible Party
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Principal Investigators
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Matija Daniel
Role: STUDY_CHAIR
Queen's Medical Center
Locations
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Children's National Medical Center
Washington D.C., District of Columbia, United States
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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CSP002
Identifier Type: -
Identifier Source: org_study_id
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