Clinical Study of the Tympanostomy Tube Delivery System (inVENT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Acclarent
ClinicalTrials.gov Identifier:
NCT00939796
First received: July 14, 2009
Last updated: June 10, 2014
Last verified: June 2014
  Purpose

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: 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 (inVENT)

Resource links provided by NLM:


Further study details as provided by Acclarent:

Primary Outcome Measures:
  • Device Success [ Time Frame: At procedure visit ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00939796

Locations
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
Acclarent
Investigators
Principal Investigator: Charles Syms, III, MD Ear Medical Group
Principal Investigator: Charles Wilson, MD Bay Area ENT
  More Information

No publications provided

Responsible Party: Acclarent
ClinicalTrials.gov Identifier: NCT00939796     History of Changes
Other Study ID Numbers: CPR005005
Study First Received: July 14, 2009
Results First Received: May 7, 2014
Last Updated: June 10, 2014
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 September 18, 2014