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Clinical Study of the Tympanostomy Tube Delivery System (inVENT)

Primary Purpose

Otitis Media With Effusion

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acclarent Tympanostomy Tube Delivery System
Sponsored by
Acclarent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Otitis Media With Effusion

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bay Area ENT
  • Ear Medical Group

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tympanostomy Tube Delivery System (TTDS)

Arm Description

Tympanostomy tube placement with Acclarent tube delivery system

Outcomes

Primary Outcome Measures

Device Success
Successful deployment of the tube in each indicated ear using the TTDS. Evaluated for test cohort subjects only (not lead-in subjects).

Secondary Outcome Measures

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.
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).

Full Information

First Posted
July 14, 2009
Last Updated
September 26, 2014
Sponsor
Acclarent
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1. Study Identification

Unique Protocol Identification Number
NCT00939796
Brief Title
Clinical Study of the Tympanostomy Tube Delivery System
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Acclarent

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Otitis Media With Effusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tympanostomy Tube Delivery System (TTDS)
Arm Type
Experimental
Arm Description
Tympanostomy tube placement with Acclarent tube delivery system
Intervention Type
Device
Intervention Name(s)
Acclarent Tympanostomy Tube Delivery System
Intervention Description
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
Primary Outcome Measure Information:
Title
Device Success
Description
Successful deployment of the tube in each indicated ear using the TTDS. Evaluated for test cohort subjects only (not lead-in subjects).
Time Frame
At procedure visit
Secondary Outcome Measure Information:
Title
Cross-Over to Manual Myringotomy and Tube Placement
Description
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.
Time Frame
at procedure visit
Title
Tube Retention
Description
Presence of the Tympanostomy Tube across the tympanic membrane at two weeks post-procedure. Evaluated for test cohort subjects only (not lead-in subjects).
Time Frame
two weeks post-procedure

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients scheduled to undergo bilateral or unilateral tympanostomy tube insertion. Either male or female 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 Stenosed ear canal
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charles Syms, III, MD
Organizational Affiliation
Ear Medical Group
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Charles Wilson, MD
Organizational Affiliation
Bay Area ENT
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bay Area ENT
City
Biloxi
State/Province
Mississippi
ZIP/Postal Code
39532
Country
United States
Facility Name
Ear Medical Group
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Clinical Study of the Tympanostomy Tube Delivery System

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