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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2011 by Acclarent.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Acclarent
ClinicalTrials.gov Identifier:
NCT01202578
First received: September 13, 2010
Last updated: May 10, 2011
Last verified: May 2011
History of Changes
  Purpose

The purpose of this study is to evaluate the performance and safety of the TTDS for chronic otitis media or recurrent acute otitis media.


Condition Intervention Phase
Otitis Media With Effusion
Acute Otitis Media
 Device: tympanostomy tube
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

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

Further study details as provided by Acclarent:

Primary Outcome Measures:
  • Safety of Tympanostomy Tube Delivery system [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
    Those adverse events which are procedural, serious, and device-related.

  • Effectiveness of the Tympanostomy Tube Delivery system [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    The successful delivery of the tympanostomy tube across the tympanic membrane.


Secondary Outcome Measures:
  • Procedure Success [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
    Successful placement of any tympanostomy tube, with no safety events.

  • Tube Retention [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Presence of the tympanostomy tube across the tympanic membrane at the follow-up visit.


Estimated Enrollment: 100
Study Start Date: September 2010
Estimated Study Completion Date: May 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
tympanostomy tube
performance and safety of tympanostomy tube delivery system
 Device: tympanostomy tube
tympanostomy tube deliver system

  Eligibility

Ages Eligible for Study:   6 Months and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01202578

Locations
United States, Texas
Xxx
San Antonio, Texas, United States, 78240
Sponsors and Collaborators
Acclarent
Investigators
Principal Investigator: xxx xxx xxx
  More Information

No publications provided

Responsible Party: Heather MacFalls, Director of Clinical Research, Acclarent, Inc.
ClinicalTrials.gov Identifier: NCT01202578     History of Changes
Other Study ID Numbers: CPR005013
Study First Received: September 13, 2010
Last Updated: May 10, 2011
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 16, 2013