Evaluation of the Tympanostomy Tube Delivery System

Acute Otitis Media Clinical Trial

— inVENT-OR  

Official title:

A Clinical Study of the Acclarent Tympanostomy Tube Delivery System for the Treatment of Patients Requiring Tympanostomy Tube Insertion for Otitis Media

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01202578
• Other study ID #: CPR005013
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: September 13, 2010
• Last updated: June 10, 2014
• Start date: September 2010
• Est. completion date: December 2010

Study information

• Verified date: June 2014
• Source: Acclarent
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: December 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Otitis Media
• Otitis
• Otitis Media
• Otitis Media with Effusion

Intervention

Device:
• tympanostomy tube
tympanostomy tube delivery system

Locations

Country	Name	City	State
United States	Evergreen Sinus Center	Kirkland	Washington
United States	Advanced ENT and Allergy	Louisville	Kentucky
United States	South Coast ENT	Port St. Lucie	Florida
United States	Ear Medical Group	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Acclarent

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of Tympanostomy Tube (TT) Delivery System	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.	7 days	Yes
Primary	Device Success	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.	0 days	No
Secondary	Proportion of Subjects With Procedure Success	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.	0 days	No
Secondary	Tube Retention	Presence of the tympanostomy tube across the tympanic membrane at the follow-up visit.	7 days	No