Evaluation of the Tympanostomy Tube Delivery System

Phase 2

Completed

• Conditions: Otitis Media With Effusion; Acute Otitis Media
• Interventions: Device: tympanostomy tube

• Registration Number: NCT01202578
• Lead Sponsor: Integra LifeSciences Corporation

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-09-13
• Study First Submitted QC: 2010-09-14
• Study First Posted: 2010-09-16
• Primary Completion: 2010-11
• Study Completion: 2010-12
• Results First Submitted: 2014-05-07
• Results First Submitted QC: 2014-06-10
• Results First Posted: 2014-07-11
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-10
• Last Update Posted: 2024-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
tympanostomy tube	tympanostomy tube	performance and safety of tympanostomy tube delivery system

Primary Outcome Measures

Name	Time	Method
Device Success	0 days	Device Success is defined as the successful delivery of the tympanostomy tube across the tympanic membrane using the tympanostomy tube delivery system (TTDS).Device Success is evaluated on a per device basis.
Safety of Tympanostomy Tube (TT) Delivery System	7 days	Occurrence of pre-defined Safety Events of acoustic trauma, deployment of the TT into the middle ear, damage to middle ear structures, unintended tympanic membrane perforation requiring treatment, abrasion to the external acoustic meatus requiring significant treatment, and major bleeding requiring significant treatment.

Secondary Outcome Measures

Name	Time	Method
Proportion of Subjects With Procedure Success	0 days	Procedure Success was defined as the successful placement of any tympanostomy tube in all enrolled ears in a given subject. Non-Acclarent tubes successfully placed manually following non-success of the TTDS were counted toward Procedure Success. Procedure Success was determined on a per subject basis: the rate was calculated by the number of subjects achieving Procedure Success out of the total number of enrolled subjects.
Tube Retention	7 days	Presence of the tympanostomy tube across the tympanic membrane at the follow-up visit.

Trial Locations

Locations (4)

South Coast ENT; 🇺🇸 Port Saint Lucie, Florida, United States

Advanced ENT and Allergy; 🇺🇸 Louisville, Kentucky, United States

Evergreen Sinus Center; 🇺🇸 Kirkland, Washington, United States

Ear Medical Group; 🇺🇸 San Antonio, Texas, United States