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In-Office Clinical Study of the Solo+ TTD
Sponsor: AventaMed DAC
Summary
The objective of this study is to evaluate the safety and effectiveness of the Solo+ Tympanostomy Tube Device (Solo+ TTD) for the placement of tympanostomy tubes in paediatric patients undergoing a tympanostomy procedure.
Official title: Pivotal In-Office Clinical Study of the Solo+ Tympanostomy Tube Device
Key Details
Gender
All
Age Range
6 Months - 13 Years
Study Type
INTERVENTIONAL
Enrollment
66
Start Date
2023-03-30
Completion Date
2028-03
Last Updated
2026-04-01
Healthy Volunteers
No
Conditions
Interventions
Solo+ Tympanostomy Tube Device (Solo+ TTD)
The Solo+ TTD is intended to deliver a tympanostomy tube through the tympanic membrane of a patient.
Locations (7)
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