Pivotal In-Office Clinical Study of the Solo+ Tympanostomy Tube Device
Status: Active_not_recruiting
Location: See all (7) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 6 months
Maximum Age: 13
Healthy Volunteers: f
View:
• Patients aged ≥6 months to \<13 years
• Planned tympanostomy tube insertion
• Patient is able to commit to the follow-up visits and assessments
Locations
United States
Alabama
Southern Head & Neck Surgery
Alexander City
North Alabama ENT
Huntsville
East Alabama ENT
Opelika
California
Sacramento ENT
Sacramento
Kentucky
Advanced ENT & Allergy
Louisville
Pennsylvania
Specialty Physician Associates
Bethlehem
South Carolina
South Carolina ENT
Columbia
Time Frame
Start Date: 2023-03-30
Completion Date: 2028-03
Participants
Target number of participants: 66
Treatments
Experimental: 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.
Related Therapeutic Areas
Sponsors
Leads: AventaMed DAC