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NCT02957578 Clinical Trial

Clinical Study of Solo Tympanostomy Tube Device (TTD)

Otitis Media Clinical Trial

Official title:
Post-Market Approval Study of the Solo Tympanostomy Tube Device

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02957578
Other study ID # 13IH026
Secondary ID 208475
Status Recruiting
Phase N/A
First received November 4, 2016
Last updated October 31, 2017
Start date December 2016
Est. completion date November 2019

Study information
Verified date October 2017
Source Nottingham University Hospitals NHS Trust
Contact Maria Koufali
Email researchsponsor@nuh.nhs.uk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a multi-centre, single arm study to evaluate the placement of tympanostomy tubes with the AventaMed Solo Tympanostomy Tube Device (TTD)

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date November 2019
Est. primary completion date September 2018
Accepts healthy volunteers No
Gender All
Age group N/A to 18 Years
Eligibility Basic Inclusion Criteria:

- Listed for bilateral tympanostomy tube insertion only

Basic Exclusion Criteria:

- Anatomy that precludes sufficient visualisation of both the left and right eardrum with the Solo TTD in place.

- Anatomy that precludes safe access to both the left and right eardrum with the Solo TTD

- Patients in whom a reliable audiogram is not possible

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Solo TTD
Placement of tympanostomy tube with Solo TTD

Locations
Country Name City State
United Kingdom Nottingham University Hospitals NHS Trust Nottingham

Sponsors (4)
Lead Sponsor Collaborator
Nottingham University Hospitals NHS Trust AventaMed DAC, Derby Hospitals NHS Foundation Trust, Sheffield Children's NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Intraoperative Device Success Number of ears in which tube placement is achieved with the Solo TTD Intraoperative
Secondary Conversion from moderate sedation Number of patients requiring conversion from moderate sedation to general anaesthesia Intraoperative
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