In-Office Clinical Study of the Solo+ TTD (VENTY)

AventaMed

Status: Enrolling

Conditions: Ear Infection; Otitis Media

Treatments: Device: Solo+ Tympanostomy Tube Device (Solo+ TTD)

Study type: Interventional

Funder types: Industry

Identifiers

NCT05741333

CSP003

Details and patient eligibility

About

The objective of this study is to evaluate the safety and effectiveness of the Solo+ Tympanostomy Tube Device (Solo+ TTD) for the placement of tympanostomy tubes in paediatric patients undergoing a tympanostomy procedure.

Full description

The study will be a multi-site, prospective, treatment-only study to gather safety and effectiveness data on the use of the Solo+ TTD in-office with topical anesthesia in children aged ≥6 months to <13 years.

Enrollment: 66 estimated patients

Sex: All

Ages: 6 months to 13 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients aged ≥6 months to <13 years
• Planned tympanostomy tube insertion
• Patient is able to commit to the follow-up visits and assessments

Exclusion criteria

• Anatomy that precludes sufficient visualization of the tympanic membrane
• Anatomy that precludes safe access to the tympanic membrane and safe use of the Solo+ TTD
• Narrow ear canals
• Congenital or craniofacial abnormalities affecting the ear
• No baseline audiometry or tympanometry
• Familial history of insensitivity to anesthetic components
• Patient unable to remain still or is unsuitable for protective stabilization to undergo an in-office procedure

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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66 participants in 1 patient group

Solo+ Tympanostomy Tube Device (Solo+ TTD)

Experimental group

Description:

The Solo+ TTD is a disposable surgical tool designed to deliver a tympanostomy tube into the tympanic membrane of patients undergoing a tympanostomy tube placement procedure.

Treatment:

Device: Solo+ Tympanostomy Tube Device (Solo+ TTD)