Otitis Media
Conditions
Keywords
Tympanostomy tube placement
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.
Interventions
DEVICEAcclarent Tympanostomy Tube Delivery system (TTDS)
placement of tympanostomy tube under local anesthesia
Sponsors
Acclarent
Integra LifeSciences Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With In-office Tube Placement Procedure Success | Day 0 | 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 | Day 0 | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Retained (TTDS-placed) Tubes | 14 days | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Tympanostomy Tube Placement 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. | 85 |
| Total | 85 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 0 |
| Overall Study | Physician Decision | 1 | 0 |
Baseline characteristics
| Characteristic | Tympanostomy Tube Placement |
|---|---|
| Age, Continuous | 17.01 years STANDARD_DEVIATION 24.19 |
| Race/Ethnicity, Customized African American | 9 participants |
| Race/Ethnicity, Customized Asian | 1 participants |
| Race/Ethnicity, Customized Other races (self-reported) | 13 participants |
| Race/Ethnicity, Customized White | 62 participants |
| Region of Enrollment United States | 85 participants |
| Sex: Female, Male Female | 40 Participants |
| Sex: Female, Male Male | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 18 / 85 |
| serious Total, serious adverse events | 1 / 85 |
Outcome results
Primary
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.
Time frame: Day 0
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tympanostomy Tube Placement | Percentage of Subjects With In-office Tube Placement Procedure Success | 93.2 Percentage of Subjects |
Primary
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.
Time frame: Day 0
Population: 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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tympanostomy Tube Placement | Percentage of Tubes Successfully Placed Using a TTDS Device | 82.2 percentage of devices |
Secondary
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.
Time frame: 14 days
Population: Total in-office (IO) subjects.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tympanostomy Tube Placement | Number of Retained (TTDS-placed) Tubes | 74 tubes |