A Clinical Study of the Acclarent Tympanostomy Tube Delivery System For the Treatment of Patients Requiring Tympanostomy Tube Insertion for Otitis Media (inVENT)

Integra LifeSciences Corporation2 sites in 1 country16 target enrollmentMarch 2009

ConditionsOtitis Media With Effusion

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Otitis Media With Effusion
Sponsor: Integra LifeSciences Corporation
Enrollment: 16
Locations: 2
Primary Endpoint: Device Success
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The objective of this investigational study is to evaluate the safety and performance of the Acclarent Tympanostomy Tube Delivery System (TTDS) for the placement of the Tympanostomy Tube [TT(s)] in patients indicated for such treatment for chronic otitis media with effusion (OME) or recurrent acute otitis media (AOM).

Registry

clinicaltrials.gov

Start Date

March 2009

End Date

July 2009

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

•Patients scheduled to undergo bilateral or unilateral tympanostomy tube insertion.
•Either male or female

Exclusion Criteria

•History of sensitivity or reaction to anesthesia chosen for the procedure
•Markedly atrophic, mono- or bimeric, severely retracted, atelectatic or perforated tympanic membrane
•Otitis externa
•Active acute otitis media
•Otitis media pathology
•Stenosed ear canal