Singapore Tympanostomy Tube Delivery System Study

January 4, 2015 updated by: Acclarent

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore
        • KK Women's and Children's Hospital Singapore

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Acclarent Tympanostomy Tube Delivery System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Procedural

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Tympanostomy Tubes Extruded at 12 Months Post Procedure
Time Frame: 12 months
12 months
Percentage of Patent Tubes
Time Frame: 30 days
This measure assesses the patency (openness or lack of obstruction) of unextruded tubes.
30 days
Percentage of Patent Tubes
Time Frame: 3 months
This measure assesses the patency (openness or lack of obstruction) of unextruded tubes.
3 months
Percentage of Patent Tubes
Time Frame: 6 months
This measure assesses the patency (openness or lack of obstruction) of unextruded tubes.
6 months
Percentage of Patent Tubes
Time Frame: 9 Months
This measure assesses the patency (openness or lack of obstruction) of unextruded tubes.
9 Months
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)
30 days
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)
3 months
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)
6 months
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)
9 months
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)
12 months post procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Acclarent

Investigators

  • Principal Investigator: Henry Tan, MD, KK Women's and Children's Hospital, Singapore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

January 11, 2010

First Submitted That Met QC Criteria

January 11, 2010

First Posted (Estimate)

January 12, 2010

Study Record Updates

Last Update Posted (Estimate)

January 15, 2015

Last Update Submitted That Met QC Criteria

January 4, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPR005004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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