Back to resultsinVENT-In-Office Study (inVENT-IO)
Primary Purpose
Otitis Media
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acclarent Tympanostomy Tube Delivery system (TTDS)
Sponsored by
About this trial
This is an interventional treatment trial for Otitis Media focused on measuring Tympanostomy tube placement
Eligibility Criteria
Inclusion Criteria:
- Scheduled to undergo tympanostomy tube insertion
- At least 6 months old
- Behavioral capacity and cooperative temperament to undergo an awake procedure (based on physician judgement)
Exclusion Criteria:
- History of sensitivity or reaction to anesthesia chosen for the procedure
- Significantly atrophic, bimeric, or completely atelectatic tympanic membrane
- Otitis externa
- Anatomy that precludes sufficient visualization of and access to the tympanic membrane
- Anatomy that necessitates tympanostomy tube placement in the posterior half of the tympanic membrane
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Tympanostomy tube placement
Arm Description
placement of tympanostomy tube under local anesthesia in office/clinic setting
Outcomes
Primary Outcome Measures
Percentage of Subjects With In-office Tube Placement Procedure Success
Procedure Success is defined as the successful placement of any tympanostomy tube in all enrolled ears in a given subject. Procedure Success is determined on a per subject basis: the rate was calculated based on the number of subjects achieving Procedure Success out of the total number of enrolled subjects. Only subjects for whom tubes were placed under local anesthesia were evaluated for Procedure Success.
Percentage of Tubes Successfully Placed Using a TTDS Device
Device (TTDS) success is defined as the successful delivery of a pre-loaded TT tube across the tympanic membrane using the TTDS. Device success will be evaluated per device attempted. Office/clinical subjects only.
A Device (Type of Unit analyzed) is defined as a TDS attempt. This is not synonymous with "tube." Tube is the outcome of the device use.
Secondary Outcome Measures
Number of Retained (TTDS-placed) Tubes
Tube retention is the presence of a TT placed successfully by the TTDS device across the tympanic membrane at the two week follow-up visit. Tube retention was confirmed by physician investigator evaluation. N=74 tubes were successfully placed intraprocedurally. Analysis population includes office/clinical subjects only.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01324271
Brief Title
inVENT-In-Office Study
Acronym
inVENT-IO
Official Title
A Clinical Study Of The Acclarent Tympanostomy Tube (Tula™) Delivery System In-Office
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (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 the study is to evaluate the safety and efficacy of the Acclarent Tympanostomy Tube Delivery System (TTDS) for the placement of tympanostomy tubes (TT) under local anesthesia in an office/clinic setting.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Otitis Media
Keywords
Tympanostomy tube placement
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
85 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tympanostomy tube placement
Arm Type
Experimental
Arm Description
placement of tympanostomy tube under local anesthesia in office/clinic setting
Intervention Type
Device
Intervention Name(s)
Acclarent Tympanostomy Tube Delivery system (TTDS)
Other Intervention Name(s)
Tula™
Intervention Description
placement of tympanostomy tube under local anesthesia
Primary Outcome Measure Information:
Title
Percentage of Subjects With In-office Tube Placement Procedure Success
Description
Procedure Success is defined as the successful placement of any tympanostomy tube in all enrolled ears in a given subject. Procedure Success is determined on a per subject basis: the rate was calculated based on the number of subjects achieving Procedure Success out of the total number of enrolled subjects. Only subjects for whom tubes were placed under local anesthesia were evaluated for Procedure Success.
Time Frame
Day 0
Title
Percentage of Tubes Successfully Placed Using a TTDS Device
Description
Device (TTDS) success is defined as the successful delivery of a pre-loaded TT tube across the tympanic membrane using the TTDS. Device success will be evaluated per device attempted. Office/clinical subjects only.
A Device (Type of Unit analyzed) is defined as a TDS attempt. This is not synonymous with "tube." Tube is the outcome of the device use.
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
Number of Retained (TTDS-placed) Tubes
Description
Tube retention is the presence of a TT placed successfully by the TTDS device across the tympanic membrane at the two week follow-up visit. Tube retention was confirmed by physician investigator evaluation. N=74 tubes were successfully placed intraprocedurally. Analysis population includes office/clinical subjects only.
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Scheduled to undergo tympanostomy tube insertion
At least 6 months old
Behavioral capacity and cooperative temperament to undergo an awake procedure (based on physician judgement)
Exclusion Criteria:
History of sensitivity or reaction to anesthesia chosen for the procedure
Significantly atrophic, bimeric, or completely atelectatic tympanic membrane
Otitis externa
Anatomy that precludes sufficient visualization of and access to the tympanic membrane
Anatomy that necessitates tympanostomy tube placement in the posterior half of the tympanic membrane
Facility Information:
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
12. IPD Sharing Statement
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inVENT-In-Office Study
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