Clinical Study of the Solo Tympanostomy Tube Device

Not Applicable

• Conditions: Ear Infection; Otitis Media
• Interventions: Device: Solo TympanostomyTube Device

• Registration Number: NCT03722160
• Lead Sponsor: AventaMed DAC

Brief Summary

The objective of this study is post-approval evaluation of 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 Start: 2018-09-13
• Study First Submitted: 2018-10-25
• Study First Submitted QC: 2018-10-25
• Study First Posted: 2018-10-26
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-25
• Last Update Posted: 2019-10-28
• Primary Completion: 2019-11
• Study Completion: 2019-11

Recruitment & Eligibility

• Status: UNKNOWN
• 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 TympanostomyTube 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	Intra-operative, 2-6 weeks post-operative	The number and type of Adverse Events

Trial Locations

Locations (3)

IRCCS Burlo-Garofolo; 🇮🇹 Trieste, Italy

Royal Derby Hospital; 🇬🇧 Derby, United Kingdom

Queen's Medical Centre; 🇬🇧 Nottingham, United Kingdom