Clinical Study of the Solo Tympanostomy Tube Device

AventaMed

Status: Unknown

Conditions: Ear Infection; Otitis Media

Treatments: Device: Solo TympanostomyTube Device

Study type: Interventional

Funder types: Industry

Identifiers

NCT03722160

CSP001

Details and patient eligibility

About

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

Full 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.

Enrollment: 27 estimated patients

Sex: All

Ages: 6 months to 15 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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27 participants in 1 patient group

Solo Tympanostomy Tube Device

Other group

Description:

The Solo Tympanostomy Tube Device is a disposable surgical tool designed to deliver a tympanostomy tube (grommet) into the tympanic membrane of patients undergoing a tympanostomy tube placement procedure

Treatment:

Device: Solo TympanostomyTube Device