Clinical Study of the Solo+ Tympanostomy Tube Device

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

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: N/A
  • Intervention Model: Single Group Assignment
  • Primary Purpose: Treatment
  • Masking: None (Open Label)
• Study Primary Completion Date: September 2024

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.

Interventions

• 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

Arms, Groups and Cohorts

• 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

Clinical Trial Outcome Measures

Primary Measures

• Successful delivery of the tympanostomy tube by the Solo+ Tympanostomy Tube Device
  • Time Frame: Intra-operative
  • The number of ears in which the Solo Tympanostomy Tube Device tube is placed
• Rate of Adverse Events
  • Time Frame: 24 months
  • The number and type of Adverse Events

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 6 Months

Maximum Age: 15 Years

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • AventaMed DAC
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Official(s)
  • Matija Daniel, Study Chair, Queen’s Medical Center