A Clinical Study Of The Acclarent Tympanostomy Tube (Tula™) Delivery System In-Office
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 85
- Locations
- 1
- Primary Endpoint
- Percentage of Subjects With In-office Tube Placement Procedure Success
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 6 Months to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Percentage of Subjects With In-office Tube Placement Procedure Success
Time Frame: Day 0
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.
Percentage of Tubes Successfully Placed Using a TTDS Device
Time Frame: Day 0
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.
Secondary Outcomes
- Number of Retained (TTDS-placed) Tubes(14 days)