Otitis Media
Conditions
Keywords
Tympanostomy tube placement, iontophoresis
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.
Interventions
DEVICETympanostomy tube placement (Acclarent iontophoresis device)
Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system following delivery of anesthetic with Acclarent iontophoresis device
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) * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Procedural, Serious and Device-related Adverse Events. | Procedure through 2 weeks post-procedure | Adverse events which are procedural, serious, and device-related. |
| Device Success | Day 0 (day of procedure) | 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
| Measure | Time frame | Description |
|---|---|---|
| Procedure Success | Day 0 (day of procedure) | 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 | Day 0 (day of procedure) | 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 | 2 weeks post-procedure | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Tympanostomy Tube Placement Tympanostomy tube placement (Acclarent iontophoresis device): Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system following delivery of anesthetic with Acclarent iontophoresis device | 42 |
| Total | 42 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
Baseline characteristics
| Characteristic | Tympanostomy Tube Placement |
|---|---|
| Age, Continuous | 39.6 years STANDARD_DEVIATION 26.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 40 Participants |
| Region of Enrollment United States | 42 participants |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 5 / 42 |
| serious Total, serious adverse events | 1 / 42 |
Outcome results
Primary
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.
Time frame: Day 0 (day of procedure)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tympanostomy Tube Placement | Device Success | 55 devices |
Primary
Number of Subjects With Procedural, Serious and Device-related Adverse Events.
Adverse events which are procedural, serious, and device-related.
Time frame: Procedure through 2 weeks post-procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tympanostomy Tube Placement | Number of Subjects With Procedural, Serious and Device-related Adverse Events. | 0 subjects |
Secondary
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.
Time frame: Day 0 (day of procedure)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tympanostomy Tube Placement | Procedure Success | 42 participants |
Secondary
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.
Time frame: Day 0 (day of procedure)
Population: The analysis population includes subjects with successful tube placement using the Tube Delivery System (TDS) in one or both ears. Six subjects were excluded for whom one ear had a successful TDS placement and one ear did not.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tympanostomy Tube Placement | Procedure Tolerability | 36 participants |
Secondary
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.
Time frame: 2 weeks post-procedure
Population: This outcome measure analysis includes evaluation only of ears with TDS-placed tube.~Two subjects (3 ears) were excluded due to missing follow-up data. An additional 3 subjects (4 ears) were excluded because no TDS tube was placed. Three of the 37 participants analyzed had one of two study ears excluded, due to no TDS in that ear.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tympanostomy Tube Placement | Tube Retention | 52 ears |