Clinical Study of Solo Tympanostomy Tube Device (TTD)

NHS Trust

Status: Unknown

Conditions: Middle Ear Effusion; Otitis Media

Treatments: Device: Solo TTD

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02957578

208475 (Other Identifier)

13IH026

Details and patient eligibility

About

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

Enrollment: 20 estimated patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Solo TTD

Experimental group

Description:

Placement of tympanostomy tube with Solo TTD

Treatment:

Device: Solo TTD