Singapore Tympanostomy Tube Delivery System Study

Otitis Media Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01046877
• Other study ID #: CPR005004
• Status: Completed
• Phase: N/A
• First received: January 11, 2010
• Last updated: January 4, 2015
• Start date: December 2008
• Est. completion date: June 2011

Study information

• Verified date: January 2015
• Source: Acclarent
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Health Sciences Authority
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: June 2011
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year and older

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Otitis
• Otitis Media

Intervention

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

Locations

Country	Name	City	State
Singapore	KK Women's and Children's Hospital Singapore	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Acclarent

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Procedural	Yes
Secondary	Percentage of Tympanostomy Tubes Extruded at 12 Months Post Procedure		12 months	No
Secondary	Percentage of Patent Tubes	This measure assesses the patency (openness or lack of obstruction) of unextruded tubes.	30 days	No
Secondary	Percentage of Patent Tubes	This measure assesses the patency (openness or lack of obstruction) of unextruded tubes.	3 months	No
Secondary	Percentage of Patent Tubes	This measure assesses the patency (openness or lack of obstruction) of unextruded tubes.	6 months	No
Secondary	Percentage of Patent Tubes	This measure assesses the patency (openness or lack of obstruction) of unextruded tubes.	9 Months	No
Secondary	Percentage of Ears With Adverse Events	This outcome measure evaluates occurrence of new adverse events since prior follow-up visit. (non-cumulative)	30 days	Yes
Secondary	Percentage of Ears With Adverse Events	This outcome measure evaluates occurrence of new adverse events since prior follow-up visit. (non-cumulative)	3 months	Yes
Secondary	Percentage of Ears With Adverse Events	This outcome measure evaluates occurrence of new adverse events since prior follow-up visit. (non-cumulative)	6 months	Yes
Secondary	Percentage of Ears With Adverse Events	This outcome measure evaluates occurrence of new adverse events since prior follow-up visit. (non-cumulative)	9 months	Yes
Secondary	Percentage of Ears With Adverse Events	This outcome measure evaluates occurrence of new adverse events since prior follow-up visit. (non-cumulative)	12 months post procedure	Yes