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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UNKNOWN
NA
27 participants
INTERVENTIONAL
2018-09-13
2019-11-30
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 TympanostomyTube 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 TympanostomyTube 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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IRCCS Burlo-Garofolo
Trieste, , Italy
Royal Derby Hospital
Derby, , United Kingdom
Queen's Medical Centre
Nottingham, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Domenico Leonardo Grasso
Role: primary
Other Identifiers
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CSP001
Identifier Type: -
Identifier Source: org_study_id
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