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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RECRUITING
NA
66 participants
INTERVENTIONAL
2023-03-30
2027-06-30
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 (Solo+ TTD)
The Solo+ TTD is a disposable surgical tool designed to deliver a tympanostomy tube into the tympanic membrane of patients undergoing a tympanostomy tube placement procedure.
Solo+ Tympanostomy Tube Device (Solo+ TTD)
The Solo+ TTD is intended to deliver a tympanostomy tube through the tympanic membrane of a patient.
Interventions
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Solo+ Tympanostomy Tube Device (Solo+ TTD)
The Solo+ TTD is intended to deliver a tympanostomy tube through the tympanic membrane of a patient.
Eligibility Criteria
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Inclusion Criteria
* Planned tympanostomy tube insertion
* Patient is able to commit to the follow-up visits and assessments
Exclusion Criteria
* Anatomy that precludes safe access to the tympanic membrane and safe use of the Solo+ TTD
* Narrow ear canals
* Congenital or craniofacial abnormalities affecting the ear
* No baseline audiometry or tympanometry
* Familial history of insensitivity to anesthetic components
* Patient unable to remain still or is unsuitable for protective stabilization to undergo an in-office procedure
6 Months
13 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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Southern Head & Neck Surgery
Alexander City, Alabama, United States
North Alabama ENT
Huntsville, Alabama, United States
East Alabama ENT
Opelika, Alabama, United States
Sacramento ENT
Sacramento, California, United States
Advanced ENT & Allergy
Louisville, Kentucky, United States
Specialty Physician Associates
Bethlehem, Pennsylvania, United States
South Carolina ENT
Columbia, South Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CSP003
Identifier Type: -
Identifier Source: org_study_id
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