Clinical Study of Solo Tympanostomy Tube Device (TTD)

Not Applicable

• Conditions: Otitis Media; Middle Ear Effusion
• Interventions: Device: Solo TTD

• Registration Number: NCT02957578
• Lead Sponsor: Nottingham University Hospitals NHS Trust

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-04
• Study First Submitted QC: 2016-11-04
• Study First Posted: 2016-11-06
• Study Start: 2016-12
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-31
• Last Update Posted: 2017-11-01
• Primary Completion: 2018-09
• Study Completion: 2019-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Solo TTD	Solo TTD	Placement of tympanostomy tube with Solo TTD

Primary Outcome Measures

Name	Time	Method
Intraoperative Device Success	Intraoperative	Number of ears in which tube placement is achieved with the Solo TTD

Secondary Outcome Measures

Name	Time	Method
Conversion from moderate sedation	Intraoperative	Number of patients requiring conversion from moderate sedation to general anaesthesia

Trial Locations

Locations (1)

Nottingham University Hospitals NHS Trust; 🇬🇧 Nottingham, United Kingdom