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Clinical Study of the Tympanostomy Tube Delivery System (inVENT)

This study has been completed.
Information provided by (Responsible Party):
Acclarent Identifier:
First received: July 14, 2009
Last updated: September 26, 2014
Last verified: September 2014
The objective of this investigational 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: Acclarent Tympanostomy Tube Delivery System

Study Type: Interventional
Study Design: 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 (inVENT)

Resource links provided by NLM:

Further study details as provided by Acclarent:

Primary Outcome Measures:
  • Device Success [ Time Frame: At procedure visit ]
    Successful deployment of the tube in each indicated ear using the TTDS. Evaluated for test cohort subjects only (not lead-in subjects).

Secondary Outcome Measures:
  • Cross-Over to Manual Myringotomy and Tube Placement [ Time Frame: at procedure visit ]
    Conversion of the procedure from Tympanostomy Tube Delivery System to manual myringotomy and tube placement. Evaluated for test cohort subjects only (not lead-in subjects). Decision to convert to a manual myringotomy and tube placement procedure occurs at the conclusion of the Tube Delivery System procedure.

  • Tube Retention [ Time Frame: two weeks post-procedure ]
    Presence of the Tympanostomy Tube across the tympanic membrane at two weeks post-procedure. Evaluated for test cohort subjects only (not lead-in subjects).

Enrollment: 16
Study Start Date: March 2009
Study Completion Date: July 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tympanostomy Tube Delivery System (TTDS)
Tympanostomy tube placement with Acclarent tube delivery system
Device: Acclarent Tympanostomy Tube Delivery System
A device which provides a means to create a myringotomy with insertion of a proloaded tympanostomy tube (TT) for placement of the TT in patients indicated for such treatment for Otitis Media


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00939796

United States, Mississippi
Bay Area ENT
Biloxi, Mississippi, United States, 39532
United States, Texas
Ear Medical Group
San Antonio, Texas, United States, 78240
Sponsors and Collaborators
Principal Investigator: Charles Syms, III, MD Ear Medical Group
Principal Investigator: Charles Wilson, MD Bay Area ENT
  More Information

Responsible Party: Acclarent Identifier: NCT00939796     History of Changes
Other Study ID Numbers: CPR005005
Study First Received: July 14, 2009
Results First Received: May 7, 2014
Last Updated: September 26, 2014

Additional relevant MeSH terms:
Otitis Media
Otitis Media with Effusion
Ear Diseases
Otorhinolaryngologic Diseases processed this record on May 25, 2017