A Clinical Study of the Acclarent Tympanostomy Tube Delivery System For The Treatment of Patients Requiring Tympanostomy Tube Insertion For Otitis Media

Integra LifeSciences Corporation1 site in 1 country25 target enrollmentDecember 2008

ConditionsOtitis Media

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Otitis Media
Sponsor: Integra LifeSciences Corporation
Enrollment: 25
Locations: 1
Primary Endpoint: Percentage of Ears Treated Successfully With the TTDS in the Absence of Acute Intraprocedural 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 (TTDS) in the placement of tympanostomy tubes (TTs) in patients indicated for such treatment for chronic otitis media with effusion (OME) or recurrent acute otitis media (AOM).

Registry

clinicaltrials.gov

Start Date

December 2008

End Date

June 2011

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

•\>= 1 year of age
•Diagnosed with either Chronic Otitis Media with Effusion or recurrent Acute Otitis Media and scheduled to undergo bilateral or unilateral tympanostomy tube insertion.
•Either male or female -

Exclusion Criteria

•History of sensitivity or reaction to anaesthesia
•Markedly atrophic, retracted, atelectatic or perforated tympanic membrane.
•Otitis externa
•Active acute otitis media
•Thickened Tympanic Membrane
•Thick mucoid effusion (also known as "glue ear")
•Otitis media pathology requiring T-tubes -

Outcomes

Primary Outcomes

Percentage of Ears Treated Successfully With the TTDS in the Absence of Acute Intraprocedural Adverse Events.

Time Frame: Procedural

TTDS success will be confirmed by the successful delivery of a tube to the tympanic membrane.

Secondary Outcomes

Percentage of Tympanostomy Tubes Extruded at 12 Months Post Procedure(12 months)
Percentage of Patent Tubes(9 Months)
Percentage of Ears With Adverse Events(12 months post procedure)