The objective of this study is post-approval evaluation of the safety and performance of the Solo Tympanostomy Tube Device for the placement of tympanostomy tubes (grommets) in paediatric patients undergoing a tympanostomy procedure
The study will be a multi-site, prospective, treatment-only study of the Solo Tympanostomy Tube Device. Patients will already have a scheduled tympanostomy procedure.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
27
The Solo Tympanostomy Tube Device is intended to deliver a tympanostomy tube through the tympanic membrane of a patient during a tympanostomy procedure.
IRCCS Burlo-Garofolo
Trieste, Italy
RECRUITINGRoyal Derby Hospital
Derby, United Kingdom
RECRUITINGQueen's Medical Centre
Nottingham, United Kingdom
COMPLETEDSuccessful delivery of the tympanostomy tube by the Solo Tympanostomy Tube Device
The number of ears in which the Solo Tympanostomy Tube Device tube is placed
Time frame: Intra-operative
Rate of Adverse Events
The number and type of Adverse Events
Time frame: Intra-operative, 2-6 weeks post-operative
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