Acclarent Tympanostomy Tube Delivery System for the Treatment of Patients Requiring Tympanostomy Tube Insertion

Not Applicable

Completed

• Conditions: Otitis Media
• Interventions: Device: Acclarent Tympanostomy Tube Delivery System (TTDS).

• Registration Number: NCT02150044
• Lead Sponsor: Integra LifeSciences Corporation

Brief Summary

This was a non-significant risk (NSR), prospective, multi-center, single arm clinical trial that aimed to evaluate safety and performance of the Acclarent Tympanostomy Tube Delivery System (TTDS).

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Primary Completion: 2010-10
• Study Completion: 2010-11
• Study First Submitted: 2014-05-27
• Study First Submitted QC: 2014-05-28
• Study First Posted: 2014-05-29
• Results First Submitted: 2014-06-26
• Results First Submitted QC: 2014-09-18
• Results First Posted: 2014-09-25
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-10
• Last Update Posted: 2024-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

Inclusion Criteria

• Diagnosed with either chronic otitis media with effusion (OME) or recurrent acute otitis media (AOM) and scheduled to undergo tympanostomy tube insertion

Exclusion Criteria

• History of sensitivity or reaction to anesthesia chosen for the procedure
• Markedly atrophic, mono- or 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 sufficient visualization of and access to the tympanic membrane
• Anatomy that necessitates tympanostomy tube placement in the posterior half of the tympanic membrane

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tympanostomy tube	Acclarent Tympanostomy Tube Delivery System (TTDS).	Performance and safety of tympanostomy tube delivery system

Primary Outcome Measures

Name	Time	Method
Ear Outcome Success	Day 0 (at procedure visit)	Ear Outcome Success is successful delivery of the tympanostomy tube (TT) across the tympanic membrane (TM) per ear. This endpoint was evaluated for the 13 study cohort subjects only (not the 16 lead-in subjects).

Secondary Outcome Measures

Name	Time	Method
Procedure Success	Day 0 (at procedure visit)	Procedure Success is the successful placement of any tympanostomy tube evaluated on a per subject basis. This endpoint was evaluated for the 13 study cohort subjects only (not the 16 lead-in subjects).
Tube Retention	1 week	Tube Retention is the presence of a TTDS-placed tympanostomy tube across the tympanic membrane (TM) at the Follow-Up visit evaluated by ear. This endpoint was evaluated for the 13 study cohort subjects only (not the 16 lead-in subjects).