Back to resultsEvaluation of the Tympanostomy Tube Delivery System (inVENT-OR)
Primary Purpose
Otitis Media With Effusion, Acute Otitis Media
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
tympanostomy tube
Sponsored by
About this trial
This is an interventional treatment trial for Otitis Media With Effusion
Eligibility Criteria
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
Sites / Locations
- South Coast ENT
- Advanced ENT and Allergy
- Ear Medical Group
- Evergreen Sinus Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
tympanostomy tube
Arm Description
performance and safety of tympanostomy tube delivery system
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
Tube Retention
Presence of the tympanostomy tube across the tympanic membrane at the follow-up visit.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01202578
Brief Title
Evaluation of the Tympanostomy Tube Delivery System
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2014
Overall Recruitment Status
Completed
Study Start Date
September 2010 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
December 2010 (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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Otitis Media With Effusion, Acute Otitis Media
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
tympanostomy tube
Arm Type
Experimental
Arm Description
performance and safety of tympanostomy tube delivery system
Intervention Type
Device
Intervention Name(s)
tympanostomy tube
Intervention Description
tympanostomy tube delivery system
Primary Outcome Measure Information:
Title
Safety of Tympanostomy Tube (TT) Delivery System
Description
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.
Time Frame
7 days
Title
Device Success
Description
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.
Time Frame
0 days
Secondary Outcome Measure Information:
Title
Proportion of Subjects With Procedure Success
Description
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.
Time Frame
0 days
Title
Tube Retention
Description
Presence of the tympanostomy tube across the tympanic membrane at the follow-up visit.
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenneth Faw, MD
Organizational Affiliation
Evergreen Sinus Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andrew Gould, MD
Organizational Affiliation
Advanced ENT and Allergy
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Charles Syms, MD
Organizational Affiliation
Ear Medical Group
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jacob Zeiders, MD
Organizational Affiliation
South Coast ENT
Official's Role
Principal Investigator
Facility Information:
Facility Name
South Coast ENT
City
Port St. Lucie
State/Province
Florida
ZIP/Postal Code
34952
Country
United States
Facility Name
Advanced ENT and Allergy
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
Ear Medical Group
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
Evergreen Sinus Center
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98034
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Tympanostomy Tube Delivery System
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