inVENT-In-Office Study (inVENT-IO)

Integra LifeSciences

Status: Completed

Conditions: Otitis Media

Treatments: Device: Acclarent Tympanostomy Tube Delivery system (TTDS)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01324271

CPR005016

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) for the placement of tympanostomy tubes (TT) under local anesthesia in an office/clinic setting.

Enrollment: 85 patients

Sex: All

Ages: 6+ months old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Scheduled to undergo tympanostomy tube insertion
• At least 6 months old
• Behavioral capacity and cooperative temperament to undergo an awake procedure (based on physician judgement)

Exclusion criteria

• History of sensitivity or reaction to anesthesia chosen for the procedure
• Significantly atrophic, bimeric, or completely atelectatic tympanic membrane
• Otitis externa
• Anatomy that precludes sufficient visualization of and access to the tympanic membrane
• Anatomy that necessitates tympanostomy tube placement in the posterior half of the tympanic membrane

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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85 participants in 1 patient group

Tympanostomy tube placement

Experimental group

Description:

placement of tympanostomy tube under local anesthesia in office/clinic setting

Treatment:

Device: Acclarent Tympanostomy Tube Delivery system (TTDS)