Clinical Study of Solo Tympanostomy Tube Device (TTD)

Nottingham University Hospitals NHS Trust20 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Otitis Media Middle Ear Effusion

Interventions

Solo TTDDEVICE

Placement of tympanostomy tube with Solo TTD

Eligibility

Sex: ALLMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Nottingham University Hospitals NHS Trust

Nottingham, United Kingdom

RECRUITING

Outcomes

Primary Outcomes

Intraoperative Device Success

Number of ears in which tube placement is achieved with the Solo TTD

Time frame: Intraoperative

Secondary Outcomes

Conversion from moderate sedation

Number of patients requiring conversion from moderate sedation to general anaesthesia

Time frame: Intraoperative

Central Contacts

Maria Koufali

CONTACT

researchsponsor@nuh.nhs.uk

Olive O'Driscoll

CONTACT

clinical@aventamed.com

Data from ClinicalTrials.gov

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