Otitis Media
Conditions
Brief summary
The objective of the study is to evaluate the safety and efficacy of the Acclarent Tula TDS for the placement of tympanostomy tubes under local anesthesia in an office/clinic setting.
Interventions
DEVICETube Delivery System (TDS)
Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system under local anesthesia in an office/clinic setting
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 21 Years
Healthy volunteers
No
Inclusion criteria
1. Scheduled to undergo tympanostomy tube insertion 2. At least 6 months old and younger than 22 years old 3. Behavioral capacity and cooperative temperament to undergo an awake procedure (based on physician judgement) 4. No history of sensitivity or reaction to anesthesia chosen for the procedure
Exclusion criteria
1. Pregnant or lactating females 2. Significantly atrophic, bimeric, or completely atelectatic tympanic membrane 3. Otitis externa 4. Lacerations or abrasions to the external auditory canal or damaged or denuded skin in the auditory canal 5. Cerumen impaction resulting in a significant amount of cleaning required to visualize the tympanic membrane 6. Electrically sensitive subjects and subjects with electrically sensitive support systems (pacemakers, defibrillators, etc.) 7. Anatomy that precludes sufficient visualization of and access to the tympanic membrane 8. Anatomy that necessitates tympanostomy tube placement in the posterior half of the tympanic membrane
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Procedural, Serious, and Device-Related Adverse Events | procedure up to 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. Tolerability was defined as an average post-procedure pain score (of treated ears) \<= 3 |
| 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 |
|---|---|
| Tube Placement Group Tube Delivery System (Tula): Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system under local anesthesia in an office/clinic setting | 70 |
| Total | 70 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Incomplete anesthesia | 5 |
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Tube Placement Group |
|---|---|
| Age, Continuous | 7.0 years STANDARD_DEVIATION 3.9 |
| Race/Ethnicity, Customized African American or Black | 5 participants |
| Race/Ethnicity, Customized Asian | 1 participants |
| Race/Ethnicity, Customized Other or Unknown | 17 participants |
| Race/Ethnicity, Customized White | 47 participants |
| Region of Enrollment United States | 70 participants |
| Sex: Female, Male Female | 36 Participants |
| Sex: Female, Male Male | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 3 / 70 |
| serious Total, serious adverse events | 0 / 70 |
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)
Population: Analysis population includes subjects who had completed the local anesthesia procedure (iontophoresis) and in which a TDS tube delivery device was attempted.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tube Placement Group | Device Success | 114 devices |
Primary
Number of Participants With Procedural, Serious, and Device-Related Adverse Events
Adverse events which are procedural, serious, and device-related.
Time frame: procedure up to 2 weeks post procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tube Placement Group | Number of Participants With Procedural, Serious, and Device-Related Adverse Events | 0 participants |
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) |
|---|---|---|
| Tube Placement Group | Procedure Success | 63 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. Tolerability was defined as an average post-procedure pain score (of treated ears) \<= 3
Time frame: Day 0 (day of procedure)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tube Placement Group | Procedure Tolerability | 59 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: Only 62 of the initial 70 subjects achieved procedure success, and were present for 2 week follow-up assessment with Tula tube in situ, such that tube retention could be measured.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tube Placement Group | Tube Retention | 111 ears |