A Clinical Study of the Acclarent Tympanostomy Tube Delivery System for the Treatment of Patients Requiring Tympanostomy Tube Insertion for Otitis Media
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Otitis Media With Effusion
- Sponsor
- Integra LifeSciences Corporation
- Enrollment
- 53
- Locations
- 4
- Primary Endpoint
- Device Success
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Device Success
Time Frame: 0 days
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.
Safety of Tympanostomy Tube (TT) Delivery System
Time Frame: 7 days
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.
Secondary Outcomes
- Proportion of Subjects With Procedure Success(0 days)
- Tube Retention(7 days)