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Completed

NCT Number: NCT01046877

Singapore Tympanostomy Tube Delivery System Study

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).

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Key information

Conditions

Otitis Media Ear Diseases Otitis Otorhinolaryngologic Diseases

Age range

1 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

KK Women's and Children's Hospital Singapore

Singapore

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • History of sensitivity or reaction to anaesthesia
  • Markedly atrophic, retracted, atelectatic or perforated tympanic membrane.
  • Otitis externa
  • Active acute otitis media
  • Thickened Tympanic Membrane
  • Thick mucoid effusion (also known as "glue ear")
  • Otitis media pathology requiring T-tubes -

Treatment and study plan

Tympanostomy Tube Delivery System

Device

Placement of the Tympanostomy Tube by the Acclarent Tympanostomy Tube Delivery System (TTDS)

Other names: Acclarent Tympanostomy Tube Delivery System

Primary outcomes

  1. 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 outcomes

  1. Percentage of Tympanostomy Tubes Extruded at 12 Months Post Procedure

    Time frame: 12 months

  2. Percentage of Patent Tubes

    Time frame: 30 days

    This measure assesses the patency (openness or lack of obstruction) of unextruded tubes.

  3. Percentage of Patent Tubes

    Time frame: 3 months

    This measure assesses the patency (openness or lack of obstruction) of unextruded tubes.

  4. Percentage of Patent Tubes

    Time frame: 6 months

    This measure assesses the patency (openness or lack of obstruction) of unextruded tubes.

  5. Percentage of Patent Tubes

    Time frame: 9 Months

    This measure assesses the patency (openness or lack of obstruction) of unextruded tubes.

  6. 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)

  7. 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)

  8. 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)

  9. 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)

  10. 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)

Sponsors and collaborators

Lead sponsor

Integra LifeSciences Corporation

Industry

Collaborators

  • Acclarent

Registry information

Official study title

A Clinical Study of the Acclarent Tympanostomy Tube Delivery System For The Treatment of Patients Requiring Tympanostomy Tube Insertion For Otitis Media

Important dates

Study start
2008
Primary completion
2010
Study completion
2011
First posted
Jan 12, 2010
Registry last updated
Aug 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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