Tympanostomy Tube Placement in Children in the Office (Inova 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 Tula TDS for the placement of tympanostomy tubes under local anesthesia in an office/clinic setting.

Official Title
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Tympanostomy Tube Placement in Children in the Office (Inova Study)

Conditions
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Otitis Media

Intervention / Treatment
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* Device: Tube Delivery System (TDS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Scheduled to undergo tympanostomy tube insertion At least 6 months old and younger than 22 years old Behavioral capacity and cooperative temperament to undergo an awake procedure (based on physician judgement) No history of sensitivity or reaction to anesthesia chosen for the procedure Exclusion Criteria: Pregnant or lactating females Significantly atrophic, bimeric, or completely atelectatic tympanic membrane Otitis externa Lacerations or abrasions to the external auditory canal or damaged or denuded skin in the auditory canal Cerumen impaction resulting in a significant amount of cleaning required to visualize the tympanic membrane Electrically sensitive subjects and subjects with electrically sensitive support systems (pacemakers, defibrillators, etc.) 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

Ages Eligible for Study
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Minimum Age: 6 Months
Maximum Age: 21 Years

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: Tube placement group<br> | Device: Tube Delivery System (TDS)<br>* Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system under local anesthesia in an office/clinic setting<br>* Other names: Tula TDS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Procedural, Serious, and Device-Related Adverse Events | Adverse events which are procedural, serious, and device-related. | procedure up to 2 weeks post procedure | 
| Device Success | Device Success is defined as the successful delivery of the tympanostomy tube (TT) across the tympanic membrane (TM) using the Tube Delivery System(TDS). Device Success will be evaluated on a per device basis. | Day 0 (day of procedure) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure Success | Procedure Success is defined as the successful placement of any tympanostomy tube in all enrolled ears in a given subject. Procedure Success is determined on a per subject basis. | Day 0 (day of procedure) | 
| Procedure Tolerability | Procedure Tolerability is defined as the proportion of subjects reporting the procedure as tolerable, where tolerable is defined as a score of 0 through 3, using the Wong-Baker FACES pain scale.The Wong-Baker FACES pain scoring system is a scale of 0 to 5, where 0 means 'no hurt', 1 = 'hurts a little bit', 2 = 'hurts little more', 3 = 'hurts even more', 4 = 'hurts whole lot' and 5 = 'hurts worst'. Procedure Tolerability will be determined on a per patient basis, with the patient's score being the average of the scores for the left and right ear if both ears are successfully treated with the Tube Delivery System. Tolerability was defined as an average post-procedure pain score (of treated ears) <= 3 | Day 0 (day of procedure) | 
| Tube Retention | Tube retention is the presence of a tympanostomy tube placed successfully by the Tula TDS device across the tympanic membrane at the two-week follow-up visit. | 2 weeks post procedure |