Singapore Tympanostomy Tube Delivery System Study

Integra LifeSciences

Status: Completed

Conditions: Otitis Media

Treatments: Device: Tympanostomy Tube Delivery System

Study type: Interventional

Funder types: Industry

Identifiers

NCT01046877

CPR005004

Details and patient eligibility

About

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).

Enrollment: 25 patients

Sex: All

Ages: 1+ year old

Volunteers: No Healthy Volunteers

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 -

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Tympanostomy Tube placement

Experimental group

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).

Treatment:

Device: Tympanostomy Tube Delivery System