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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01202578
Recruitment Status : Completed
First Posted : September 16, 2010
Results First Posted : July 11, 2014
Last Update Posted : July 11, 2014
Sponsor:
Information provided by (Responsible Party):
Acclarent

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Otitis Media With Effusion Acute Otitis Media Device: tympanostomy tube Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Clinical Study of the Acclarent Tympanostomy Tube Delivery System for the Treatment of Patients Requiring Tympanostomy Tube Insertion for Otitis Media
Study Start Date : September 2010
Primary Completion Date : November 2010
Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ear Infections
U.S. FDA Resources

Arm Intervention/treatment
Experimental: tympanostomy tube
performance and safety of tympanostomy tube delivery system
Device: tympanostomy tube
tympanostomy tube delivery system



Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01202578


Locations
United States, Florida
South Coast ENT
Port St. Lucie, Florida, United States, 34952
United States, Kentucky
Advanced ENT and Allergy
Louisville, Kentucky, United States, 40207
United States, Texas
Ear Medical Group
San Antonio, Texas, United States, 78240
United States, Washington
Evergreen Sinus Center
Kirkland, Washington, United States, 98034
Sponsors and Collaborators
Acclarent
Investigators
Principal Investigator: Kenneth Faw, MD Evergreen Sinus Center
Principal Investigator: Andrew Gould, MD Advanced ENT and Allergy
Principal Investigator: Charles Syms, MD Ear Medical Group
Principal Investigator: Jacob Zeiders, MD South Coast ENT

Responsible Party: Acclarent
ClinicalTrials.gov Identifier: NCT01202578     History of Changes
Other Study ID Numbers: CPR005013
First Posted: September 16, 2010    Key Record Dates
Results First Posted: July 11, 2014
Last Update Posted: July 11, 2014
Last Verified: June 2014

Additional relevant MeSH terms:
Otitis
Otitis Media
Otitis Media with Effusion
Ear Diseases
Otorhinolaryngologic Diseases