Evaluation of the Tympanostomy Tube Delivery System (inVENT-OR)

June 10, 2014 updated by: Acclarent

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Port St. Lucie, Florida, United States, 34952
        • South Coast ENT
    • Kentucky
      • Louisville, Kentucky, United States, 40207
        • Advanced ENT and Allergy
    • Texas
      • San Antonio, Texas, United States, 78240
        • Ear Medical Group
    • Washington
      • Kirkland, Washington, United States, 98034
        • Evergreen Sinus Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: tympanostomy tube
performance and safety of tympanostomy tube delivery system
Device: tympanostomy tube
tympanostomy tube delivery system

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
7 days
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.
0 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
0 days
Tube Retention
Time Frame: 7 days
Presence of the tympanostomy tube across the tympanic membrane at the follow-up visit.
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Acclarent

Investigators

  • Principal Investigator: Kenneth Faw, MD, Evergreen Sinus Center
  • Principal Investigator: Andrew Gould, MD, Advanced ENT and Allergy
  • Principal Investigator: Jacob Zeiders, MD, South Coast ENT

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (ACTUAL)

November 1, 2010

Study Completion (ACTUAL)

December 1, 2010

Study Registration Dates

First Submitted

September 13, 2010

First Submitted That Met QC Criteria

September 14, 2010

First Posted (ESTIMATE)

September 16, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

July 11, 2014

Last Update Submitted That Met QC Criteria

June 10, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPR005013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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