Clinical Study of the Tympanostomy Tube Delivery System (inVENT)

Integra LifeSciences

Status: Completed

Conditions: Otitis Media With Effusion

Treatments: Device: Acclarent Tympanostomy Tube Delivery System

Study type: Interventional

Funder types: Industry

Identifiers

NCT00939796

CPR005005

Details and patient eligibility

About

The objective of this investigational study is to evaluate the safety and performance of the Acclarent Tympanostomy Tube Delivery System (TTDS) for the placement of the Tympanostomy Tube [TT(s)] in patients indicated for such treatment for chronic otitis media with effusion (OME) or recurrent acute otitis media (AOM).

Enrollment: 16 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients scheduled to undergo bilateral or unilateral tympanostomy tube insertion.
2. Either male or female

Exclusion criteria

1. History of sensitivity or reaction to anesthesia chosen for the procedure
2. Markedly atrophic, mono- or bimeric, severely retracted, atelectatic or perforated tympanic membrane
3. Otitis externa
4. Active acute otitis media
5. Otitis media pathology
6. Stenosed ear canal

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

Tympanostomy Tube Delivery System (TTDS)

Experimental group

Description:

Tympanostomy tube placement with Acclarent tube delivery system

Treatment:

Device: Acclarent Tympanostomy Tube Delivery System