Evaluation of the Tympanostomy Tube Delivery System

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the performance and safety of the Tympanostomy Tube Delivery System (TTDS) for chronic otitis media or recurrent acute otitis media.

Official Title
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A Clinical Study of the Acclarent Tympanostomy Tube Delivery System for the Treatment of Patients Requiring Tympanostomy Tube Insertion for Otitis Media

Conditions
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Otitis Media With Effusion, Acute Otitis Media

Intervention / Treatment
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* Device: tympanostomy tube


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed with either chronic otitis media with effusion or acute otitis media and scheduled to undergo tympanostomy tube insertion Exclusion Criteria: Reaction to anesthesia Markedly atrophic, 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 visualization and access to tympanic membrane Anatomy that necessitates tympanostomy tube placement in posterior half of membrane

Ages Eligible for Study
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Minimum Age: 6 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tympanostomy tube<br>performance and safety of tympanostomy tube delivery system | Device: tympanostomy tube<br>* tympanostomy tube delivery system<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of Tympanostomy Tube (TT) Delivery System | Occurrence of pre-defined Safety Events of acoustic trauma, deployment of the TT into the middle ear, damage to middle ear structures, unintended tympanic membrane perforation requiring treatment, abrasion to the external acoustic meatus requiring significant treatment, and major bleeding requiring significant treatment. | 7 days | 
| Device Success | Device Success is defined as the successful delivery of the tympanostomy tube across the tympanic membrane using the tympanostomy tube delivery system (TTDS).Device Success is evaluated on a per device basis. | 0 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Subjects With Procedure Success | Procedure Success was defined as the successful placement of any tympanostomy tube in all enrolled ears in a given subject. Non-Acclarent tubes successfully placed manually following non-success of the TTDS were counted toward Procedure Success. Procedure Success was determined on a per subject basis: the rate was calculated by the number of subjects achieving Procedure Success out of the total number of enrolled subjects. | 0 days | 
| Tube Retention | Presence of the tympanostomy tube across the tympanic membrane at the follow-up visit. | 7 days |