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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Acclarent
ClinicalTrials.gov Identifier:
NCT01202578
First received: September 13, 2010
Last updated: June 10, 2014
Last verified: June 2014
  Purpose

The purpose of this study is to evaluate the performance and safety of the Tympanostomy Tube Delivery System (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: 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:


Further study details as provided by Acclarent:

Primary Outcome Measures:
  • Safety of Tympanostomy Tube (TT) Delivery System [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
    Occurrence of pre-defined Safety Events of acoustic trauma, deployment of the TT into the middle ear, damage to middle ear structures, unintended tympanic membrane perforation requiring treatment, abrasion to the external acoustic meatus requiring significant treatment, and major bleeding requiring significant treatment.

  • Device Success [ Time Frame: 0 days ] [ Designated as safety issue: No ]
    Device Success is defined as the successful delivery of the tympanostomy tube across the tympanic membrane using the tympanostomy tube delivery system (TTDS).Device Success is evaluated on a per device basis.


Secondary Outcome Measures:
  • Proportion of Subjects With Procedure Success [ Time Frame: 0 days ] [ Designated as safety issue: No ]
    Procedure Success was defined as the successful placement of any tympanostomy tube in all enrolled ears in a given subject. Non-Acclarent tubes successfully placed manually following non-success of the TTDS were counted toward Procedure Success. Procedure Success was determined on a per subject basis: the rate was calculated by the number of subjects achieving Procedure Success out of the total number of enrolled subjects.

  • 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.


Enrollment: 53
Study Start Date: September 2010
Study Completion Date: December 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: tympanostomy tube
performance and safety of tympanostomy tube delivery system
Device: tympanostomy tube
tympanostomy tube delivery 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
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: NCT01202578

Locations
United States, Florida
South Coast ENT
Port St. Lucie, Florida, United States, 34952
United States, Kentucky
Advanced ENT and Allergy
Louisville, Kentucky, United States, 40207
United States, Texas
Ear Medical Group
San Antonio, Texas, United States, 78240
United States, Washington
Evergreen Sinus Center
Kirkland, Washington, United States, 98034
Sponsors and Collaborators
Acclarent
Investigators
Principal Investigator: Kenneth Faw, MD Evergreen Sinus Center
Principal Investigator: Andrew Gould, MD Advanced ENT and Allergy
Principal Investigator: Charles Syms, MD Ear Medical Group
Principal Investigator: Jacob Zeiders, MD South Coast ENT
  More Information

No publications provided

Responsible Party: Acclarent
ClinicalTrials.gov Identifier: NCT01202578     History of Changes
Other Study ID Numbers: CPR005013
Study First Received: September 13, 2010
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