Children's National

Clinical Study of the Solo+ Tympanostomy Tube Device

Purpose

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

Conditions

Ear Infection
Otitis Media

Eligibility

Eligible Ages: Between 6 Months and 15 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

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

Study Design

Phase: N/A
Study Type: Interventional
Allocation: N/A
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental Solo+ Tympanostomy Tube Device	The Solo+ Tympanostomy Tube Device is a disposable surgical tool designed to deliver a tympanostomy tube (grommet) into the tympanic membrane of patients undergoing a tympanostomy tube placement procedure	Device: Solo+ Tympanostomy Tube Device The Solo+ Tympanostomy Tube Device is intended to deliver a tympanostomy tube through the tympanic membrane of a patient during a tympanostomy procedure

Recruiting Locations

More Details

NCT ID: NCT04148417
Status: Active, not recruiting
Sponsor: AventaMed DAC

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.