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UNKNOWNNANCT03722160

Clinical Study of the Solo Tympanostomy Tube Device

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 und...

Lead sponsor: AventaMed DAC•3 locations•View source on ClinicalTrials.gov

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Contacts

Olive O'Driscoll

CONTACT

+353 21 492 8980 clinical@aventamed.com

Sponsors

Lead Sponsor

AventaMed DAC

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.

Age

0 - 15 years

Sex

ALL

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: October 28, 2019Terms

Trial snapshot

StatusUNKNOWN

PhaseNA

Enrollment27

Start dateSep 2018

Last updatedOct 28, 2019

Condition

Ear Infection Otitis Media

Locations shown

IRCCS Burlo-Garofolo

Trieste

Royal Derby Hospital

Derby

Queen's Medical Centre

Nottingham

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 28, 2019Data synced to Clareo: April 28, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions