Trial Outcomes & Findings for Adult Study to Evaluate Placement of Tympanostomy Tubes In-office (ADEPT) (NCT NCT03197558)
NCT ID: NCT03197558
Last Updated: 2020-01-18
Results Overview
The VAS consists of a 100 millimeter (mm) line with a statement at each end representing the extreme limits of pain intensity where a score of 0 represents "No pain" and a score of 100 represents "The worst possible pain". Following TDS tube placement, the subject will report their post-tube placement ear discomfort for each ear undergoing tube placement using the VAS. For subjects treated bilaterally, the highest (worst) score reported will be used as the unit of analysis.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
Day of procedure (Day 0)- Immediately after tube placement
Results posted on
2020-01-18
Participant Flow
Participant milestones
| Measure |
Tube Insertion Using Tube Delivery System (TDS)
Active Tymbion iontophoresis and tubes using the TDS
Tymbion Iontophoresis and Tube Delivery System (TDS): Subjects will receive active Tymbion iontophoresis and will have tubes placed using the TDS in all ears indicated for tube placement.
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
29
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Tube Insertion Using Tube Delivery System (TDS)
Active Tymbion iontophoresis and tubes using the TDS
Tymbion Iontophoresis and Tube Delivery System (TDS): Subjects will receive active Tymbion iontophoresis and will have tubes placed using the TDS in all ears indicated for tube placement.
|
|---|---|
|
Overall Study
Tubes not placed
|
1
|
Baseline Characteristics
Adult Study to Evaluate Placement of Tympanostomy Tubes In-office (ADEPT)
Baseline characteristics by cohort
| Measure |
Tube Insertion Using Tube Delivery System (TDS)
n=30 Participants
Active Tymbion iontophoresis and tubes using the TDS
Tymbion Iontophoresis and Tube Delivery System (TDS): Subjects will receive active Tymbion iontophoresis and will have tubes placed using the TDS in all ears indicated for tube placement.
|
|---|---|
|
Age, Continuous
|
54.9 years
STANDARD_DEVIATION 15.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
30 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day of procedure (Day 0)- Immediately after tube placementThe VAS consists of a 100 millimeter (mm) line with a statement at each end representing the extreme limits of pain intensity where a score of 0 represents "No pain" and a score of 100 represents "The worst possible pain". Following TDS tube placement, the subject will report their post-tube placement ear discomfort for each ear undergoing tube placement using the VAS. For subjects treated bilaterally, the highest (worst) score reported will be used as the unit of analysis.
Outcome measures
| Measure |
Tube Insertion Using Tube Delivery System (TDS)
n=29 Participants
Active Tymbion iontophoresis and tubes using the TDS
Tymbion Iontophoresis and Tube Delivery System (TDS): Subjects will receive active Tymbion iontophoresis and will have tubes placed using the TDS in all ears indicated for tube placement.
|
|---|---|
|
Subject-reported Pain Score Following Tube Delivery System (TDS) Tube Placement Using the Visual Analogue Scale (VAS) by Subject Compared to a Performance Goal.
|
9.4 millimeters
Standard Deviation 15.7
|
Adverse Events
Tube Insertion Using Tube Delivery System (TDS)
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Tube Insertion Using Tube Delivery System (TDS)
n=30 participants at risk
Active Tymbion iontophoresis and tubes using the TDS
Tymbion Iontophoresis and Tube Delivery System (TDS): Subjects will receive active Tymbion iontophoresis and will have tubes placed using the TDS in all ears indicated for tube placement.
|
|---|---|
|
Ear and labyrinth disorders
Inadequate anesthesia
|
3.3%
1/30 • Number of events 1 • Procedure through 3-week post-procedure follow-up visit.
|
|
Ear and labyrinth disorders
Ear discomfort
|
3.3%
1/30 • Number of events 1 • Procedure through 3-week post-procedure follow-up visit.
|
|
Ear and labyrinth disorders
Tube in middle ear
|
3.3%
1/30 • Number of events 1 • Procedure through 3-week post-procedure follow-up visit.
|
|
Ear and labyrinth disorders
Vertigo
|
3.3%
1/30 • Number of events 1 • Procedure through 3-week post-procedure follow-up visit.
|
|
Ear and labyrinth disorders
Dizziness
|
3.3%
1/30 • Number of events 1 • Procedure through 3-week post-procedure follow-up visit.
|
|
Ear and labyrinth disorders
Tube occlusion
|
6.7%
2/30 • Number of events 2 • Procedure through 3-week post-procedure follow-up visit.
|
|
Metabolism and nutrition disorders
Dehydration
|
3.3%
1/30 • Number of events 1 • Procedure through 3-week post-procedure follow-up visit.
|
|
Ear and labyrinth disorders
Otorrhea
|
3.3%
1/30 • Number of events 1 • Procedure through 3-week post-procedure follow-up visit.
|
|
Renal and urinary disorders
Incontinence
|
3.3%
1/30 • Number of events 1 • Procedure through 3-week post-procedure follow-up visit.
|
|
Respiratory, thoracic and mediastinal disorders
Change in respiration rate
|
6.7%
2/30 • Number of events 2 • Procedure through 3-week post-procedure follow-up visit.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee PI must submit communications to Sponsor for review and comment to verify accurate content at least 30 days prior to submitting to any third party. A delay up to 90 days may be requested by Sponsor in order to file patent applications relating to an Invention if applicable. Sponsor and PI agree that any Institution Publication shall only be made after the Multicenter Publication, provided that the Multicenter Publication is submitted within 18 months after conclusion of the study at all sites.
- Publication restrictions are in place
Restriction type: OTHER