Clinical Study of the Tympanostomy Tube Delivery System (inVENT)

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

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).

Study Overview

• Status: Completed
• Conditions: Otitis Media With Effusion
• Intervention / Treatment: Device: Acclarent Tympanostomy Tube Delivery System

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Mississippi
    • Biloxi, Mississippi, United States, 39532
      • Bay Area ENT
  • Texas
    • San Antonio, Texas, United States, 78240
      • Ear Medical Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tympanostomy Tube Delivery System (TTDS); Tympanostomy tube placement with Acclarent tube delivery system	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Acclarent
• Investigators: Principal Investigator: Charles Syms, III, MD, Ear Medical Group; Principal Investigator: Charles Wilson, MD, Bay Area ENT

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Actual): June 1, 2009
• Study Completion (Actual): July 1, 2009

Study Registration Dates

• First Submitted: July 14, 2009
• First Submitted That Met QC Criteria: July 14, 2009
• First Posted (Estimate): July 15, 2009

Study Record Updates

• Last Update Posted (Estimate): October 6, 2014
• Last Update Submitted That Met QC Criteria: September 26, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Otorhinolaryngologic Diseases; Ear Diseases; Otitis; Otitis Media; Otitis Media with Effusion
• Other Study ID Numbers: CPR005005