Clinical Study of the Tympanostomy Tube Delivery System

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).

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Key information

Conditions

OTITIS MEDIA WITH EFFUSION Ear Diseases Otitis Otitis Media Otorhinolaryngologic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bay Area ENT, Biloxi, Mississippi, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acclarent Tympanostomy Tube Delivery System

Device

A device which provides a means to create a myringotomy with insertion of a proloaded tympanostomy tube (TT) for placement of the TT in patients indicated for such treatment for Otitis Media

Primary outcomes

Device Success

Time frame: At procedure visit

Successful deployment of the tube in each indicated ear using the TTDS. Evaluated for test cohort subjects only (not lead-in subjects).

Secondary outcomes

Cross-Over to Manual Myringotomy and Tube Placement

Time frame: at procedure visit

Conversion of the procedure from Tympanostomy Tube Delivery System to manual myringotomy and tube placement. Evaluated for test cohort subjects only (not lead-in subjects). Decision to convert to a manual myringotomy and tube placement procedure occurs at the conclusion of the Tube Delivery System procedure.
Tube Retention

Time frame: two weeks post-procedure

Presence of the Tympanostomy Tube across the tympanic membrane at two weeks post-procedure. Evaluated for test cohort subjects only (not lead-in subjects).

Sponsors and collaborators

Lead sponsor

Integra LifeSciences Corporation

Industry

Collaborators

Acclarent

Registry information

Official study title

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

Acronym: inVENT

Important dates

Study start: 2009
Primary completion: 2009
Study completion: 2009
First posted: Jul 15, 2009
Registry last updated: Aug 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed