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Acclarent Tympanostomy Tube Delivery System for the Treatment of Patients Requiring Tympanostomy Tube Insertion (inVENT2)

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: NCT02150044
Recruitment Status : Completed
First Posted : May 29, 2014
Results First Posted : September 25, 2014
Last Update Posted : October 6, 2014
Sponsor:
Information provided by (Responsible Party):
Acclarent

Study Description
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Brief Summary:
This was a non-significant risk (NSR), prospective, multi-center, single arm clinical trial that aimed to evaluate safety and performance of the Acclarent Tympanostomy Tube Delivery System (TTDS).

Condition or disease Intervention/treatment Phase
Otitis Media Device: Acclarent Tympanostomy Tube Delivery System (TTDS). Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: N/A
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 : February 2010
Actual Primary Completion Date : October 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ear Infections

Arms and Interventions
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Arm Intervention/treatment
Experimental: Tympanostomy tube
Performance and safety of tympanostomy tube delivery system
 Device: Acclarent Tympanostomy Tube Delivery System (TTDS).
tympanostomy tube delivery system


Outcome Measures
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Primary Outcome Measures :
  1. Ear Outcome Success [ Time Frame: Day 0 (at procedure visit) ]
    Ear Outcome Success is successful delivery of the tympanostomy tube (TT) across the tympanic membrane (TM) per ear. This endpoint was evaluated for the 13 study cohort subjects only (not the 16 lead-in subjects).


Secondary Outcome Measures :
  1. Procedure Success [ Time Frame: Day 0 (at procedure visit) ]
    Procedure Success is the successful placement of any tympanostomy tube evaluated on a per subject basis. This endpoint was evaluated for the 13 study cohort subjects only (not the 16 lead-in subjects).

  2. Tube Retention [ Time Frame: 1 week ]
    Tube Retention is the presence of a TTDS-placed tympanostomy tube across the tympanic membrane (TM) at the Follow-Up visit evaluated by ear. This endpoint was evaluated for the 13 study cohort subjects only (not the 16 lead-in subjects).


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with either chronic otitis media with effusion (OME) or recurrent acute otitis media (AOM) and scheduled to undergo tympanostomy tube insertion

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 requiring T-tubes
  • Stenosed ear canal
  • Anatomy that precludes sufficient visualization of and access to the tympanic membrane
  • Anatomy that necessitates tympanostomy tube placement in the posterior half of the tympanic membrane
Contacts and Locations
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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): NCT02150044


Locations
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United States, Washington
Kirkland, Washington, United States, 98034
Sponsors and Collaborators
Acclarent
More Information
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Responsible Party: Acclarent
ClinicalTrials.gov Identifier: NCT02150044    
Other Study ID Numbers: CPR005008
First Posted: May 29, 2014    Key Record Dates
Results First Posted: September 25, 2014
Last Update Posted: October 6, 2014
Last Verified: September 2014
Additional relevant MeSH terms:
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Otitis
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases