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Singapore Tympanostomy Tube Delivery System Study

Primary Purpose

Otitis Media

Status

Completed

Phase

Not Applicable

Locations

Singapore

Study Type

Interventional

Intervention

Tympanostomy Tube Delivery System

About this trial

This is an interventional treatment trial for Otitis Media

Eligibility Criteria

1 Year - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 -

Sites / Locations

KK Women's and Children's Hospital Singapore

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tympanostomy Tube placement

Arm Description

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).

Outcomes

Primary Outcome Measures

Percentage of Ears Treated Successfully With the TTDS in the Absence of Acute Intraprocedural Adverse Events.

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

Percentage of Patent Tubes

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

Percentage of Patent Tubes

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

Percentage of Patent Tubes

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

Percentage of Patent Tubes

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

Percentage of Ears With Adverse Events

This outcome measure evaluates occurrence of new adverse events since prior follow-up visit. (non-cumulative)

Percentage of Ears With Adverse Events

This outcome measure evaluates occurrence of new adverse events since prior follow-up visit. (non-cumulative)

Percentage of Ears With Adverse Events

This outcome measure evaluates occurrence of new adverse events since prior follow-up visit. (non-cumulative)

Percentage of Ears With Adverse Events

This outcome measure evaluates occurrence of new adverse events since prior follow-up visit. (non-cumulative)

Percentage of Ears With Adverse Events

This outcome measure evaluates occurrence of new adverse events since prior follow-up visit. (non-cumulative)

Full Information

NCT ID

NCT01046877

First Posted

January 11, 2010

Last Updated

January 4, 2015

Sponsor

Acclarent

1. Study Identification

Unique Protocol Identification Number

NCT01046877

Brief Title

Singapore Tympanostomy Tube Delivery System Study

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2015

Overall Recruitment Status

Completed

Study Start Date

December 2008 (undefined)

Primary Completion Date

August 2010 (Actual)

Study Completion Date

June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Acclarent

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Otitis Media

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tympanostomy Tube placement

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

Tympanostomy Tube Delivery System

Other Intervention Name(s)

Acclarent Tympanostomy Tube Delivery System

Intervention Description

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

Primary Outcome Measure Information:

Title

Percentage of Ears Treated Successfully With the TTDS in the Absence of Acute Intraprocedural Adverse Events.

Description

TTDS success will be confirmed by the successful delivery of a tube to the tympanic membrane.

Time Frame

Procedural

Secondary Outcome Measure Information:

Title

Percentage of Tympanostomy Tubes Extruded at 12 Months Post Procedure

Time Frame

12 months

Title

Percentage of Patent Tubes

Description

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

Time Frame

30 days

Title

Percentage of Patent Tubes

Description

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

Time Frame

3 months

Title

Percentage of Patent Tubes

Description

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

Time Frame

6 months

Title

Percentage of Patent Tubes

Description

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

Time Frame

9 Months

Title

Percentage of Ears With Adverse Events

Description

This outcome measure evaluates occurrence of new adverse events since prior follow-up visit. (non-cumulative)

Time Frame

30 days

Title

Percentage of Ears With Adverse Events

Description

This outcome measure evaluates occurrence of new adverse events since prior follow-up visit. (non-cumulative)

Time Frame

3 months

Title

Percentage of Ears With Adverse Events

Description

This outcome measure evaluates occurrence of new adverse events since prior follow-up visit. (non-cumulative)

Time Frame

6 months

Title

Percentage of Ears With Adverse Events

Description

This outcome measure evaluates occurrence of new adverse events since prior follow-up visit. (non-cumulative)

Time Frame

9 months

Title

Percentage of Ears With Adverse Events

Description

This outcome measure evaluates occurrence of new adverse events since prior follow-up visit. (non-cumulative)

Time Frame

12 months post procedure

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Year

Accepts Healthy Volunteers

Eligibility Criteria

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 -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Henry Tan, MD

Organizational Affiliation

KK Women's and Children's Hospital, Singapore

Official's Role

Principal Investigator

Facility Information:

Facility Name

KK Women's and Children's Hospital Singapore

City

Singapore

Country

Singapore

12. IPD Sharing Statement

Learn more about this trial

Singapore Tympanostomy Tube Delivery System Study

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