Acclarent Tympanostomy Tube Delivery System for the Treatment of Patients Requiring Tympanostomy Tube Insertion (inVENT2)

Integra LifeSciences

Status: Completed

Conditions: Otitis Media

Treatments: Device: Acclarent Tympanostomy Tube Delivery System (TTDS).

Study type: Interventional

Funder types: Industry

Identifiers

NCT02150044

CPR005008

Details and patient eligibility

About

This was a non-significant risk (NSR), prospective, multi-center, single arm clinical trial that aimed to evaluate safety and performance of the Acclarent Tympanostomy Tube Delivery System (TTDS).

Enrollment: 29 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed with either chronic otitis media with effusion (OME) or recurrent acute otitis media (AOM) and scheduled to undergo tympanostomy tube insertion

Exclusion criteria

• History of sensitivity or reaction to anesthesia chosen for the procedure
• Markedly atrophic, mono- or bimeric, severely retracted, atelectatic or perforated tympanic membrane
• Otitis externa
• Active acute otitis media
• Otitis media pathology requiring T-tubes
• Stenosed ear canal
• Anatomy that precludes sufficient visualization of and access to the tympanic membrane
• Anatomy that necessitates tympanostomy tube placement in the posterior half of the tympanic membrane

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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29 participants in 1 patient group

Tympanostomy tube

Experimental group

Description:

Performance and safety of tympanostomy tube delivery system

Treatment:

Device: Acclarent Tympanostomy Tube Delivery System (TTDS).