Trial Outcomes & Findings for inVENT-In-Office Study (NCT NCT01324271)
NCT ID: NCT01324271
Last Updated: 2024-08-06
Results Overview
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.
COMPLETED
NA
85 participants
Day 0
2024-08-06
Participant Flow
Lead-ins \& study cohort included (n=85). Same criteria/procedure for all 85 subjects. Study phases did not have different start/end dates. Periods/dates for lead-ins \& cohort not different. Physicians with no TTDS experience were required to perform lead-ins in OR (n=26/85). Sites on-boarded and completed lead-ins at different times.
Participant milestones
| Measure |
Tympanostomy Tube Placement (Lead-In Procedures)
Acclarent Tympanostomy Tube Delivery system (TTDS):
Placement of tympanostomy tube under local anesthesia in office/clinic setting or under general anesthesia in operating room.
|
Tympanostomy Tube Placement (Study Cohort)
Acclarent Tympanostomy Tube Delivery system (TTDS): Placement of tympanostomy tube under local anesthesia in office/clinic setting
|
|---|---|---|
|
Overall Study
STARTED
|
57
|
28
|
|
Overall Study
COMPLETED
|
53
|
28
|
|
Overall Study
NOT COMPLETED
|
4
|
0
|
Reasons for withdrawal
| Measure |
Tympanostomy Tube Placement (Lead-In Procedures)
Acclarent Tympanostomy Tube Delivery system (TTDS):
Placement of tympanostomy tube under local anesthesia in office/clinic setting or under general anesthesia in operating room.
|
Tympanostomy Tube Placement (Study Cohort)
Acclarent Tympanostomy Tube Delivery system (TTDS): Placement of tympanostomy tube under local anesthesia in office/clinic setting
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
Baseline Characteristics
inVENT-In-Office Study
Baseline characteristics by cohort
| Measure |
Tympanostomy Tube Placement
n=85 Participants
All enrolled subjects for which a tympanostomy tube was attempted to be placed using a Tympanostomy Tube Delivery System (TTDS) under local anesthesia in office/clinical setting.
|
|---|---|
|
Age, Continuous
|
17.01 years
STANDARD_DEVIATION 24.19 • n=5 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
9 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
62 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other races (self-reported)
|
13 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
85 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0Procedure 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.
Outcome measures
| Measure |
Tympanostomy Tube Placement
n=59 Participants
All enrolled subjects for which a tympanostomy tube was attempted to be placed using a Tympanostomy Tube Delivery System (TTDS) under local anesthesia in office/clinical setting.
|
|---|---|
|
Percentage of Subjects With In-office Tube Placement Procedure Success
|
93.2 Percentage of Subjects
Interval 83.5 to 98.1
|
PRIMARY outcome
Timeframe: Day 0Population: All enrolled subjects for which a tympanostomy tube was attempted to be placed using a Tympanostomy Tube Delivery System (TTDS) under local anesthesia in office/clinical setting
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.
Outcome measures
| Measure |
Tympanostomy Tube Placement
n=90 TTDS devices
All enrolled subjects for which a tympanostomy tube was attempted to be placed using a Tympanostomy Tube Delivery System (TTDS) under local anesthesia in office/clinical setting.
|
|---|---|
|
Percentage of Tubes Successfully Placed Using a TTDS Device
|
82.2 percentage of devices
Interval 72.7 to 89.5
|
SECONDARY outcome
Timeframe: 14 daysPopulation: Total in-office (IO) subjects.
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.
Outcome measures
| Measure |
Tympanostomy Tube Placement
n=74 tubes placed via TTDS
All enrolled subjects for which a tympanostomy tube was attempted to be placed using a Tympanostomy Tube Delivery System (TTDS) under local anesthesia in office/clinical setting.
|
|---|---|
|
Number of Retained (TTDS-placed) Tubes
|
74 tubes
|
Adverse Events
Tympanostomy Tube Placement
Serious adverse events
| Measure |
Tympanostomy Tube Placement
n=85 participants at risk
All enrolled subjects for which a tympanostomy tube was attempted to be placed using a Tympanostomy Tube Delivery System (TTDS).
|
|---|---|
|
Gastrointestinal disorders
Small Bowel Obstruction
|
1.2%
1/85 • Number of events 1 • 2 weeks post-procedure
|
Other adverse events
| Measure |
Tympanostomy Tube Placement
n=85 participants at risk
All enrolled subjects for which a tympanostomy tube was attempted to be placed using a Tympanostomy Tube Delivery System (TTDS).
|
|---|---|
|
Ear and labyrinth disorders
Occluded TT
|
8.2%
7/85 • Number of events 7 • 2 weeks post-procedure
|
|
Ear and labyrinth disorders
Otalgia
|
3.5%
3/85 • Number of events 3 • 2 weeks post-procedure
|
|
Ear and labyrinth disorders
Otitis Media
|
2.4%
2/85 • Number of events 2 • 2 weeks post-procedure
|
|
Ear and labyrinth disorders
Otorrhea
|
1.2%
1/85 • Number of events 1 • 2 weeks post-procedure
|
|
Ear and labyrinth disorders
Aural Fullness
|
1.2%
1/85 • Number of events 1 • 2 weeks post-procedure
|
|
Nervous system disorders
Vertigo
|
1.2%
1/85 • Number of events 1 • 2 weeks post-procedure
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
2.4%
2/85 • Number of events 2 • 2 weeks post-procedure
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngitis
|
1.2%
1/85 • Number of events 1 • 2 weeks post-procedure
|
|
Gastrointestinal disorders
Gastroenteritis
|
1.2%
1/85 • Number of events 1 • 2 weeks post-procedure
|
|
Ear and labyrinth disorders
Tube Medialization
|
1.2%
1/85 • Number of events 1 • 2 weeks post-procedure
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60