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Singapore Tympanostomy Tube Delivery System Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01046877
First Posted: January 12, 2010
Last Update Posted: January 15, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Acclarent
  Purpose
The objective of the study is to evaluate the safety and efficacy of the Acclarent Tympanostomy Tube Delivery System (TTDS) in the placement of tympanostomy tubes (TTs) in patients indicated for such treatment for chronic otitis media with effusion (OME) or recurrent acute otitis media (AOM).

Condition Intervention
Otitis Media Device: Tympanostomy Tube Delivery System

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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:
  • Percentage of Ears Treated Successfully With the TTDS in the Absence of Acute Intraprocedural Adverse Events. [ Time Frame: Procedural ]
    TTDS success will be confirmed by the successful delivery of a tube to the tympanic membrane.


Secondary Outcome Measures:
  • Percentage of Tympanostomy Tubes Extruded at 12 Months Post Procedure [ Time Frame: 12 months ]
  • Percentage of Patent Tubes [ Time Frame: 30 days ]
    This measure assesses the patency (openness or lack of obstruction) of unextruded tubes.

  • Percentage of Patent Tubes [ Time Frame: 3 months ]
    This measure assesses the patency (openness or lack of obstruction) of unextruded tubes.

  • Percentage of Patent Tubes [ Time Frame: 6 months ]
    This measure assesses the patency (openness or lack of obstruction) of unextruded tubes.

  • Percentage of Patent Tubes [ Time Frame: 9 Months ]
    This measure assesses the patency (openness or lack of obstruction) of unextruded tubes.

  • Percentage of Ears With Adverse Events [ Time Frame: 30 days ]
    This outcome measure evaluates occurrence of new adverse events since prior follow-up visit. (non-cumulative)

  • Percentage of Ears With Adverse Events [ Time Frame: 3 months ]
    This outcome measure evaluates occurrence of new adverse events since prior follow-up visit. (non-cumulative)

  • Percentage of Ears With Adverse Events [ Time Frame: 6 months ]
    This outcome measure evaluates occurrence of new adverse events since prior follow-up visit. (non-cumulative)

  • Percentage of Ears With Adverse Events [ Time Frame: 9 months ]
    This outcome measure evaluates occurrence of new adverse events since prior follow-up visit. (non-cumulative)

  • Percentage of Ears With Adverse Events [ Time Frame: 12 months post procedure ]
    This outcome measure evaluates occurrence of new adverse events since prior follow-up visit. (non-cumulative)


Enrollment: 25
Study Start Date: December 2008
Study Completion Date: June 2011
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tympanostomy Tube placement
Tympanostomy Tube Delivery System (TTDS) used for placement of tympanostomy tubes in patients indicated for such treatment for chronic Otitis Media with Effusion (OME) or recurrent Acute Otitis Media(AOM).
Device: Tympanostomy Tube Delivery System
Placement of the Tympanostomy Tube by the Acclarent Tympanostomy Tube Delivery System (TTDS)
Other Name: Acclarent Tympanostomy Tube Delivery System

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. >= 1 year of age
  2. Diagnosed with either Chronic Otitis Media with Effusion or recurrent Acute Otitis Media and scheduled to undergo bilateral or unilateral tympanostomy tube insertion.
  3. Either male or female -

Exclusion Criteria:

  1. History of sensitivity or reaction to anaesthesia
  2. Markedly atrophic, retracted, atelectatic or perforated tympanic membrane.
  3. Otitis externa
  4. Active acute otitis media
  5. Thickened Tympanic Membrane
  6. Thick mucoid effusion (also known as "glue ear")
  7. Otitis media pathology requiring T-tubes -
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01046877


Locations
Singapore
KK Women's and Children's Hospital Singapore
Singapore, Singapore
Sponsors and Collaborators
Acclarent
Investigators
Principal Investigator: Henry Tan, MD KK Women's and Children's Hospital, Singapore
  More Information

Responsible Party: Acclarent
ClinicalTrials.gov Identifier: NCT01046877     History of Changes
Other Study ID Numbers: CPR005004
First Submitted: January 11, 2010
First Posted: January 12, 2010
Results First Submitted: November 12, 2014
Results First Posted: November 18, 2014
Last Update Posted: January 15, 2015
Last Verified: January 2015

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