Clinical Study of the Solo+ Tympanostomy Tube Device

AventaMed DAC27 enrolled

Overview

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

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

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Ear Infection Otitis Media

Interventions

Solo+ Tympanostomy Tube DeviceDEVICE

The Solo+ Tympanostomy Tube Device is intended to deliver a tympanostomy tube through the tympanic membrane of a patient during a tympanostomy procedure

Eligibility

Sex: ALLMin age: 6 MonthsMax age: 15 Years

Medical Language ↔ Plain English

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

Locations (2)

Children's National Medical Center

Washington D.C., District of Columbia, United States

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, United States

Outcomes

Primary Outcomes

Successful 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: 24 months

Data from ClinicalTrials.gov

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