Clinical Study of the Solo+ Tympanostomy Tube Device

AventaMed DAC2 sites in 1 country27 target enrollmentFebruary 9, 2021

ConditionsEar Infection Otitis Media

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Ear Infection
Sponsor: AventaMed DAC
Enrollment: 27
Locations: 2
Primary Endpoint: Successful delivery of the tympanostomy tube by the Solo+ Tympanostomy Tube Device
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of this study is to evaluate the safety and performance of the Solo+ Tympanostomy Tube Device for the placement of tympanostomy tubes (grommets) in paediatric patients undergoing a tympanostomy procedure

Detailed Description

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.

Registry

clinicaltrials.gov

Start Date

February 9, 2021

End Date

September 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

AventaMed DAC

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Listed for bilateral tympanostomy tube insertion

Exclusion Criteria

•Anatomy that precludes sufficient visualisation of both the left and right eardrum
•Narrow ear canals
•Anatomy that precludes safe access to both the left and right eardrum
•Membrane \>25% sclerosis
•Congenital or craniofacial abnormalities
•No available baseline audiometry and tympanometry