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NCT03722160 Clinical Trial

Clinical Study of the Solo Tympanostomy Tube Device

Otitis Media Clinical Trial

Official title:
Clinical Study of the Solo Tympanostomy Tube Device

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT03722160
Other study ID # CSP001
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 13, 2018
Est. completion date November 2019

Study information
Verified date October 2019
Source AventaMed DAC
Contact Olive O'Driscoll
Phone +353 21 492 8980
Email clinical@aventamed.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 27
Est. completion date November 2019
Est. primary completion date November 2019
Accepts healthy volunteers No
Gender All
Age group 6 Months to 15 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• Solo TympanostomyTube Device
The Solo Tympanostomy Tube Device is intended to deliver a tympanostomy tube through the tympanic membrane of a patient during a tympanostomy procedure.

Locations
Country Name City State
Italy IRCCS Burlo-Garofolo Trieste
United Kingdom Royal Derby Hospital Derby
United Kingdom Queen's Medical Centre Nottingham

Sponsors (1)
Lead Sponsor Collaborator
AventaMed DAC

Countries where clinical trial is conducted

Italy,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Successful delivery of the tympanostomy tube by the Solo Tympanostomy Tube Device The number of ears in which the Solo Tympanostomy Tube Device tube is placed Intra-operative
Primary Rate of Adverse Events The number and type of Adverse Events Intra-operative, 2-6 weeks post-operative
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