Evaluation of the Tympanostomy Tube Delivery System (inVENT-OR)

Integra LifeSciences

Status and phase: Completed; Phase 3; Phase 2

Conditions: Acute Otitis Media; Otitis Media With Effusion

Treatments: Device: tympanostomy tube

Study type: Interventional

Funder types: Industry

Identifiers

NCT01202578

CPR005013

Details and patient eligibility

About

The purpose of this study is to evaluate the performance and safety of the Tympanostomy Tube Delivery System (TTDS) for chronic otitis media or recurrent acute otitis media.

Enrollment: 53 patients

Sex: All

Ages: 6+ months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed with either chronic otitis media with effusion or acute otitis media and scheduled to undergo tympanostomy tube insertion

Exclusion criteria

• Reaction to anesthesia
• Markedly atrophic, bimeric, severely retracted, atelectatic or perforated tympanic membrane
• Otitis externa
• Active acute otitis media
• Otitis media pathology requiring T-tubes
• Stenosed ear canal
• Anatomy that precludes visualization and access to tympanic membrane
• Anatomy that necessitates tympanostomy tube placement in posterior half of membrane

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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53 participants in 1 patient group

tympanostomy tube

Experimental group

Description:

performance and safety of tympanostomy tube delivery system

Treatment:

Device: tympanostomy tube