Singapore Tympanostomy Tube Delivery System Study

Study Overview
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Brief Summary
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The objective of the study is to evaluate the safety and efficacy of the Acclarent Tympanostomy Tube Delivery System (TTDS) in the placement of tympanostomy tubes (TTs) in patients indicated for such treatment for chronic otitis media with effusion (OME) or recurrent acute otitis media (AOM).

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

Intervention / Treatment
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* Device: Tympanostomy Tube Delivery System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >= 1 year of age Diagnosed with either Chronic Otitis Media with Effusion or recurrent Acute Otitis Media and scheduled to undergo bilateral or unilateral tympanostomy tube insertion. Either male or female - Exclusion Criteria: History of sensitivity or reaction to anaesthesia Markedly atrophic, retracted, atelectatic or perforated tympanic membrane. Otitis externa Active acute otitis media Thickened Tympanic Membrane Thick mucoid effusion (also known as glue ear) Otitis media pathology requiring T-tubes -

Ages Eligible for Study
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Minimum Age: 1 Year

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 placement<br>Tympanostomy Tube Delivery System (TTDS) used for placement of tympanostomy tubes in patients indicated for such treatment for chronic Otitis Media with Effusion (OME) or recurrent Acute Otitis Media(AOM). | Device: Tympanostomy Tube Delivery System<br>* Placement of the Tympanostomy Tube by the Acclarent Tympanostomy Tube Delivery System (TTDS)<br>* Other names: Acclarent Tympanostomy Tube Delivery System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Ears Treated Successfully With the TTDS in the Absence of Acute Intraprocedural Adverse Events. | TTDS success will be confirmed by the successful delivery of a tube to the tympanic membrane. | Procedural | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Tympanostomy Tubes Extruded at 12 Months Post Procedure |  | 12 months | 
| Percentage of Patent Tubes | This measure assesses the patency (openness or lack of obstruction) of unextruded tubes. | 30 days | 
| Percentage of Patent Tubes | This measure assesses the patency (openness or lack of obstruction) of unextruded tubes. | 3 months | 
| Percentage of Patent Tubes | This measure assesses the patency (openness or lack of obstruction) of unextruded tubes. | 6 months | 
| Percentage of Patent Tubes | This measure assesses the patency (openness or lack of obstruction) of unextruded tubes. | 9 Months | 
| Percentage of Ears With Adverse Events | This outcome measure evaluates occurrence of new adverse events since prior follow-up visit. (non-cumulative) | 30 days | 
| Percentage of Ears With Adverse Events | This outcome measure evaluates occurrence of new adverse events since prior follow-up visit. (non-cumulative) | 3 months | 
| Percentage of Ears With Adverse Events | This outcome measure evaluates occurrence of new adverse events since prior follow-up visit. (non-cumulative) | 6 months | 
| Percentage of Ears With Adverse Events | This outcome measure evaluates occurrence of new adverse events since prior follow-up visit. (non-cumulative) | 9 months | 
| Percentage of Ears With Adverse Events | This outcome measure evaluates occurrence of new adverse events since prior follow-up visit. (non-cumulative) | 12 months post procedure |