Pivotal In-Office Clinical Study of the Solo+ Tympanostomy Tube Device
Status: 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
RECRUITING
Alexander City
North Alabama ENT
RECRUITING
Huntsville
East Alabama ENT
RECRUITING
Opelika
California
Sacramento ENT
ACTIVE_NOT_RECRUITING
Sacramento
Kentucky
Advanced ENT & Allergy
ACTIVE_NOT_RECRUITING
Louisville
Pennsylvania
Specialty Physician Associates
ACTIVE_NOT_RECRUITING
Bethlehem
South Carolina
South Carolina ENT
ACTIVE_NOT_RECRUITING
Columbia
Contact Information
Primary
Keith Jansen
clinical@aventamed.com
+353 21 492 8980
Time Frame
Start Date: 2023-03-30
Estimated Completion Date: 2027-06
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