Singapore Tympanostomy Tube Delivery System Study

Integra LifeSciences Corporation25 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Otitis Media

Interventions

Tympanostomy Tube Delivery SystemDEVICE

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

Eligibility

Sex: ALLMin age: 1 Year

Medical Language ↔ Plain English

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 -

Locations (1)

KK Women's and Children's Hospital Singapore

Singapore, Singapore

Outcomes

Primary Outcomes

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.

Time frame: Procedural

Secondary Outcomes

Percentage of Tympanostomy Tubes Extruded at 12 Months Post Procedure

Time frame: 12 months

Percentage of Patent Tubes

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

Time frame: 30 days

Percentage of Patent Tubes

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

Time frame: 3 months

Percentage of Patent Tubes

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

Time frame: 6 months

Percentage of Patent Tubes

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

Time frame: 9 Months

Percentage of Ears With Adverse Events

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

Time frame: 30 days

Percentage of Ears With Adverse Events

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

Data from ClinicalTrials.gov

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