Back to resultsinVENT-visIOn Study (inVENT-visIOn)
Primary Purpose
Otitis Media
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tympanostomy tube placement (Acclarent iontophoresis device)
Sponsored by
About this trial
This is an interventional treatment trial for Otitis Media focused on measuring Tympanostomy tube placement, iontophoresis
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)
- No history of sensitivity or reaction to anesthesia chosen for the procedure
Exclusion Criteria:
- Pregnant or lactating females
- Significantly atrophic, bimeric, or completely atelectatic tympanic membrane
- Otitis externa
- Lacerations or abrasions to the external auditory canal or damaged or denuded skin in the auditory canal
- Cerumen impaction resulting in a significant amount of cleaning required to visualize the tympanic membrane
- Electrically sensitive subjects and subjects with electrically sensitive support systems (pacemakers, defibrillators, etc.)
- 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
- South Coast Ear, Nose, & Throat
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Tympanostomy Tube Placement
Arm Description
Outcomes
Primary Outcome Measures
Number of Subjects With Procedural, Serious and Device-related Adverse Events.
Adverse events which are procedural, serious, and device-related.
Device Success
Device Success is defined as the successful delivery of the tympanostomy tube (TT) across the tympanic membrane (TM) using the Tube Delivery System(TDS). Device Success will be evaluated on a per device basis.
Secondary Outcome Measures
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.
Procedure Tolerability
Procedure Tolerability is defined as the proportion of subjects reporting the procedure as tolerable, where tolerable is defined as a score of 0 through 3, using the Wong-Baker FACES pain scale.The Wong-Baker FACES pain scoring system is a scale of 0 to 5, where 0 means 'no hurt', 1 = 'hurts a little bit', 2 = 'hurts little more', 3 = 'hurts even more', 4 = 'hurts whole lot' and 5 = 'hurts worst'. Procedure Tolerability will be determined on a per patient basis, with the patient's score being the average of the scores for the left and right ear if both ears are successfully treated with the Tube Delivery System.
Tube Retention
Tube retention is the presence of a tympanostomy tube placed successfully by the Tula TDS device across the tympanic membrane at the two-week follow-up visit.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01444391
Brief Title
inVENT-visIOn Study
Acronym
inVENT-visIOn
Official Title
A Clinical Study of the Acclarent Tympanostomy Tube Delivery and Iontophoresis Systems In-Office
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
June 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 (TDS) for the placement of Tympanostomy Tube TT(s) under local anesthesia delivered by iontophoresis 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, iontophoresis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tympanostomy Tube Placement
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Tympanostomy tube placement (Acclarent iontophoresis device)
Intervention Description
Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system following delivery of anesthetic with Acclarent iontophoresis device
Primary Outcome Measure Information:
Title
Number of Subjects With Procedural, Serious and Device-related Adverse Events.
Description
Adverse events which are procedural, serious, and device-related.
Time Frame
Procedure through 2 weeks post-procedure
Title
Device Success
Description
Device Success is defined as the successful delivery of the tympanostomy tube (TT) across the tympanic membrane (TM) using the Tube Delivery System(TDS). Device Success will be evaluated on a per device basis.
Time Frame
Day 0 (day of procedure)
Secondary Outcome Measure Information:
Title
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.
Time Frame
Day 0 (day of procedure)
Title
Procedure Tolerability
Description
Procedure Tolerability is defined as the proportion of subjects reporting the procedure as tolerable, where tolerable is defined as a score of 0 through 3, using the Wong-Baker FACES pain scale.The Wong-Baker FACES pain scoring system is a scale of 0 to 5, where 0 means 'no hurt', 1 = 'hurts a little bit', 2 = 'hurts little more', 3 = 'hurts even more', 4 = 'hurts whole lot' and 5 = 'hurts worst'. Procedure Tolerability will be determined on a per patient basis, with the patient's score being the average of the scores for the left and right ear if both ears are successfully treated with the Tube Delivery System.
Time Frame
Day 0 (day of procedure)
Title
Tube Retention
Description
Tube retention is the presence of a tympanostomy tube placed successfully by the Tula TDS device across the tympanic membrane at the two-week follow-up visit.
Time Frame
2 weeks post-procedure
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)
No history of sensitivity or reaction to anesthesia chosen for the procedure
Exclusion Criteria:
Pregnant or lactating females
Significantly atrophic, bimeric, or completely atelectatic tympanic membrane
Otitis externa
Lacerations or abrasions to the external auditory canal or damaged or denuded skin in the auditory canal
Cerumen impaction resulting in a significant amount of cleaning required to visualize the tympanic membrane
Electrically sensitive subjects and subjects with electrically sensitive support systems (pacemakers, defibrillators, etc.)
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacob W. Zeiders, M.D.
Organizational Affiliation
South Coast Ear, Nose & Throat
Official's Role
Principal Investigator
Facility Information:
Facility Name
South Coast Ear, Nose, & Throat
City
Port St. Lucie
State/Province
Florida
ZIP/Postal Code
34952
Country
United States
12. IPD Sharing Statement
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