inVENT-In-Office 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) for the placement of tympanostomy tubes (TT) under local anesthesia in an office/clinic setting.

Official Title
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A Clinical Study Of The Acclarent Tympanostomy Tube (Tula™) Delivery System In-Office

Conditions
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Otitis Media

Intervention / Treatment
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* Device: Acclarent Tympanostomy Tube Delivery system (TTDS)


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 Behavioral capacity and cooperative temperament to undergo an awake procedure (based on physician judgement) Exclusion Criteria: History of sensitivity or reaction to anesthesia chosen for the procedure Significantly atrophic, bimeric, or completely atelectatic tympanic membrane Otitis externa 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

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>placement of tympanostomy tube under local anesthesia in office/clinic setting | Device: Acclarent Tympanostomy Tube Delivery system (TTDS)<br>* placement of tympanostomy tube under local anesthesia<br>* Other names: Tula™;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects With In-office Tube Placement 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: the rate was calculated based on the number of subjects achieving Procedure Success out of the total number of enrolled subjects. Only subjects for whom tubes were placed under local anesthesia were evaluated for Procedure Success. | Day 0 | 
| Percentage of Tubes Successfully Placed Using a TTDS Device | Device (TTDS) success is defined as the successful delivery of a pre-loaded TT tube across the tympanic membrane using the TTDS. Device success will be evaluated per device attempted. Office/clinical subjects only. A Device (Type of Unit analyzed) is defined as a TDS attempt. This is not synonymous with tube. Tube is the outcome of the device use. | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Retained (TTDS-placed) Tubes | Tube retention is the presence of a TT placed successfully by the TTDS device across the tympanic membrane at the two week follow-up visit. Tube retention was confirmed by physician investigator evaluation. N=74 tubes were successfully placed intraprocedurally. Analysis population includes office/clinical subjects only. | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tympanostomy tube placement