A Clinical Study of the Acclarent Tympanostomy Tube Delivery and Iontophoresis Systems In-Office

Integra LifeSciences Corporation1 site in 1 country42 target enrollmentOctober 2011

ConditionsOtitis Media

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Otitis Media
Sponsor: Integra LifeSciences Corporation
Enrollment: 42
Locations: 1
Primary Endpoint: Number of Subjects With Procedural, Serious and Device-related Adverse Events.
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of the study is to evaluate the safety and efficacy of the Acclarent Tympanostomy Tube Delivery System (TDS) for the placement of Tympanostomy Tube TT(s) under local anesthesia delivered by iontophoresis in an office/clinic setting.

Registry

clinicaltrials.gov

Start Date

October 2011

End Date

June 2012

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Integra LifeSciences Corporation

Responsible Party

Sponsor

Eligibility Criteria

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)
•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

Outcomes

Primary Outcomes

Number of Subjects With Procedural, Serious and Device-related Adverse Events.

Time Frame: Procedure through 2 weeks post-procedure

Adverse events which are procedural, serious, and device-related.

Device Success

Time Frame: Day 0 (day of procedure)

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.