Clinical Study of the Solo+ Tympanostomy Tube Device

Not Applicable

Active, not recruiting

• Conditions: Otitis Media; Ear Infection
• Interventions: Device: Solo+ Tympanostomy Tube Device

• Registration Number: NCT04148417
• Lead Sponsor: AventaMed DAC

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.

Study Timeline

• Study First Submitted: 2019-10-30
• Study First Submitted QC: 2019-10-31
• Study First Posted: 2019-11-01
• Study Start: 2021-02-09
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-23
• Last Update Posted: 2024-01-24
• Primary Completion: 2024-09
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 27

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Solo+ Tympanostomy Tube Device	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

Primary Outcome Measures

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

Trial Locations

Locations (2)

Children's National Medical Center; 🇺🇸 Washington, District of Columbia, United States

Children's Hospital of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States