Skip to main content
OpenTrials
Completed

NCT Number: NCT01202578

Evaluation of the Tympanostomy Tube Delivery System

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

OTITIS MEDIA WITH EFFUSION Acute Otitis Media Ear Diseases Otitis Otitis Media Otorhinolaryngologic Diseases

Age range

6 month and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

South Coast ENT, Port Saint Lucie, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

tympanostomy tube

Device

tympanostomy tube delivery system

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Proportion of Subjects With Procedure Success

    Time frame: 0 days

    Procedure Success was defined as the successful placement of any tympanostomy tube in all enrolled ears in a given subject. Non-Acclarent tubes successfully placed manually following non-success of the TTDS were counted toward Procedure Success. Procedure Success was determined on a per subject basis: the rate was calculated by the number of subjects achieving Procedure Success out of the total number of enrolled subjects.

  2. Tube Retention

    Time frame: 7 days

    Presence of the tympanostomy tube across the tympanic membrane at the follow-up visit.

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

Acronym: inVENT-OR

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Sep 16, 2010
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.

Related clinical trials

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