Singapore Tympanostomy Tube Delivery System Study

Not Applicable

Completed

• Conditions: Otitis Media
• Interventions: Device: Tympanostomy Tube Delivery System

• Registration Number: NCT01046877
• Lead Sponsor: Integra LifeSciences Corporation

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2010-01-11
• Study First Submitted QC: 2010-01-11
• Study First Posted: 2010-01-12
• Primary Completion: 2010-08
• Study Completion: 2011-06
• Results First Submitted: 2014-11-12
• Results First Submitted QC: 2014-11-12
• Results First Posted: 2014-11-18
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-10
• Last Update Posted: 2024-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tympanostomy Tube placement	Tympanostomy Tube Delivery System	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).

Primary Outcome Measures

Name	Time	Method
Percentage of Ears Treated Successfully With the TTDS in the Absence of Acute Intraprocedural Adverse Events.	Procedural	TTDS success will be confirmed by the successful delivery of a tube to the tympanic membrane.

Secondary Outcome Measures

Name	Time	Method
Percentage of Patent Tubes	9 Months	This measure assesses the patency (openness or lack of obstruction) of unextruded tubes.
Percentage of Tympanostomy Tubes Extruded at 12 Months Post Procedure	12 months
Percentage of Ears With Adverse Events	12 months post procedure	This outcome measure evaluates occurrence of new adverse events since prior follow-up visit. (non-cumulative)

Trial Locations

Locations (1)

KK Women's and Children's Hospital Singapore; 🇸🇬 Singapore, Singapore