Clinical Study of the Tympanostomy Tube Delivery System (inVENT)

This study has been completed.
Sponsor:
Information provided by:
Acclarent
ClinicalTrials.gov Identifier:
NCT00939796
First received: July 14, 2009
Last updated: May 9, 2011
Last verified: May 2011
  Purpose

The objective of this study is to evaluate the safety and performance of the Acclarent Tympanostomy Tube Delivery System (TTDS) for the placement of the Tympanostomy Tube [TT(s)] in patients indicated for such treatment for chronic otitis media with effusion (OME) or recurrent acute otitis media (AOM).


Condition Intervention
Otitis Media With Effusion
Device: Tympanostomy Tube Delivery System

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

Resource links provided by NLM:


Further study details as provided by Acclarent:

Primary Outcome Measures:
  • Device Success, defined as the creation of a myringotomy and placement of the Acclarent Tympanostomy Tube across the tympanic membrane [ Time Frame: Procedural ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cross-Over, which is defined as conversion of the procedure from Tympanostomy Tube Delivery System to the standard of care (manual myringotomy and tube placement). [ Time Frame: Procedural ] [ Designated as safety issue: No ]
  • Presence of the Tympanostomy Tube across the tympanic membrane at two weeks post-procedure. [ Time Frame: two weeks post-procedure ] [ Designated as safety issue: No ]
  • Adverse Events, which is defined as the occurrence of periprocedural Tympanostomy Tube Delivery System -related adverse events (intraprocedure through two weeks post procedure). [ Time Frame: Procedural ] [ Designated as safety issue: Yes ]

Enrollment: 16
Study Start Date: May 2009
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: tympanostomy tube
Placement of tympanostomy tube with Acclarent delivery system
Device: Tympanostomy Tube Delivery System
Placement of the Tympanostomy Tube by The Acclarent Tympanostomy Tube Delivery System (TTDS)
Other Name: Acclarent Typanostomy Tube Delivery System

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients scheduled to undergo bilateral or unilateral tympanostomy tube insertion.
  2. Either male or female

Exclusion Criteria:

  1. History of sensitivity or reaction to anesthesia chosen for the procedure
  2. Markedly atrophic, mono- or bimeric, severely retracted, atelectatic or perforated tympanic membrane
  3. Otitis externa
  4. Active acute otitis media
  5. Otitis media pathology
  6. Stenosed ear canal
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00939796

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

No publications provided

Responsible Party: Heather MacFalls, Director of Clinical Research, Acclarent, Inc.
ClinicalTrials.gov Identifier: NCT00939796     History of Changes
Other Study ID Numbers: CPR005005
Study First Received: July 14, 2009
Last Updated: May 9, 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 April 15, 2014