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.
The study will be a multi-site, prospective, treatment-only study to gather safety and effectiveness data on the use of the Solo+ TTD in-office with topical anesthesia in children aged ≥6 months to \<13 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
66
The Solo+ TTD is intended to deliver a tympanostomy tube through the tympanic membrane of a patient.
Southern Head & Neck Surgery
Alexander City, Alabama, United States
RECRUITINGNorth Alabama ENT
Huntsville, Alabama, United States
RECRUITINGEast Alabama ENT
Opelika, Alabama, United States
Procedure Success
Percentage of subjects in which the Solo+ TTD tympanostomy tube is inserted in all indicated ears
Time frame: Intra-operative
Rate of Adverse Events
Incidence and nature of device- or procedure-related adverse events
Time frame: 24 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Sacramento ENT
Sacramento, California, United States
ACTIVE_NOT_RECRUITINGAdvanced ENT & Allergy
Louisville, Kentucky, United States
ACTIVE_NOT_RECRUITINGSpecialty Physician Associates
Bethlehem, Pennsylvania, United States
ACTIVE_NOT_RECRUITINGSouth Carolina ENT
Columbia, South Carolina, United States
ACTIVE_NOT_RECRUITING