Clinical Study of the Tympanostomy Tube Delivery System

Otitis Media With Effusion Clinical Trial

— inVENT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00939796
• Other study ID #: CPR005005
• Status: Completed
• Phase: N/A
• First received: July 14, 2009
• Last updated: September 26, 2014
• Start date: March 2009
• Est. completion date: July 2009

Study information

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

Clinical Trial Summary

The objective of this investigational study is to evaluate the safety and performance of the Acclarent Tympanostomy Tube Delivery System (TTDS) for the placement of the Tympanostomy Tube [TT(s)] in patients indicated for such treatment for chronic otitis media with effusion (OME) or recurrent acute otitis media (AOM).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: July 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Patients scheduled to undergo bilateral or unilateral tympanostomy tube insertion.

2. Either male or female

Exclusion Criteria:

1. History of sensitivity or reaction to anesthesia chosen for the procedure

2. Markedly atrophic, mono- or bimeric, severely retracted, atelectatic or perforated tympanic membrane

3. Otitis externa

4. Active acute otitis media

5. Otitis media pathology

6. Stenosed ear canal

Study Design

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

Related Conditions & MeSH terms

• Otitis
• Otitis Media
• Otitis Media with Effusion

Intervention

Device:
• Acclarent Tympanostomy Tube Delivery System
A device which provides a means to create a myringotomy with insertion of a proloaded tympanostomy tube (TT) for placement of the TT in patients indicated for such treatment for Otitis Media

Locations

Country	Name	City	State
United States	Bay Area ENT	Biloxi	Mississippi
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	Device Success	Successful deployment of the tube in each indicated ear using the TTDS. Evaluated for test cohort subjects only (not lead-in subjects).	At procedure visit	No
Secondary	Cross-Over to Manual Myringotomy and Tube Placement	Conversion of the procedure from Tympanostomy Tube Delivery System to manual myringotomy and tube placement. Evaluated for test cohort subjects only (not lead-in subjects). Decision to convert to a manual myringotomy and tube placement procedure occurs at the conclusion of the Tube Delivery System procedure.	at procedure visit	No
Secondary	Tube Retention	Presence of the Tympanostomy Tube across the tympanic membrane at two weeks post-procedure. Evaluated for test cohort subjects only (not lead-in subjects).	two weeks post-procedure	No