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Singapore Tympanostomy Tube Delivery System Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Acclarent
ClinicalTrials.gov Identifier:
NCT01046877
First received: January 11, 2010
Last updated: November 12, 2014
Last verified: November 2014
  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: 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:
  • Percentage of Devices Successfully Placed in the Absence of Acute Intraprocedural Adverse Events. [ Time Frame: Procedural ] [ Designated as safety issue: Yes ]
    TTDS success will be confirmed by the successful delivery of a tube to the desired location on the tympanic membrane.


Secondary Outcome Measures:
  • Percentage of Tympanostomy Tubes Extruded at 12 Months Post Procedure [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Percentage of Patent Tubes [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    This measure assesses the patency (openness or lack of obstruction) of unextruded tubes.

  • Percentage of Patent Tubes [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    This measure assesses the patency (openness or lack of obstruction) of unextruded tubes.

  • Percentage of Patent Tubes [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    This measure assesses the patency (openness or lack of obstruction) of unextruded tubes.

  • Percentage of Patent Tubes [ Time Frame: 9 Months ] [ Designated as safety issue: No ]
    This measure assesses the patency (openness or lack of obstruction) of unextruded tubes.

  • Percentage of Patent Tubes [ Time Frame: 12 months post procedure ] [ Designated as safety issue: No ]
    This measure assesses the patency (openness or lack of obstruction) of unextruded tubes.

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

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

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

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

  • Percentage of Adverse Events [ Time Frame: 12 months post procedure ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   1 Year and older
Genders Eligible for Study:   Both
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
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: 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

No publications provided

Responsible Party: Acclarent
ClinicalTrials.gov Identifier: NCT01046877     History of Changes
Other Study ID Numbers: CPR005004
Study First Received: January 11, 2010
Results First Received: November 12, 2014
Last Updated: November 12, 2014
Health Authority: Singapore: Health Sciences Authority

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

ClinicalTrials.gov processed this record on November 20, 2014