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| Name | Class |
|---|---|
| Acclarent | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tympanostomy Tube Placement | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tympanostomy tube placement (Acclarent iontophoresis device) | Device | Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system following delivery of anesthetic with Acclarent iontophoresis device |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Subjects With Procedural, Serious and Device-related Adverse Events. | Adverse events which are procedural, serious, and device-related. | Procedure through 2 weeks post-procedure |
| 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. | Day 0 (day of procedure) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 0 (day of procedure) |
| Procedure Tolerability |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jacob W. Zeiders, M.D. | South Coast Ear, Nose & Throat | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| South Coast Ear, Nose, & Throat | Port Saint Lucie | Florida | 34952 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All enrolled subjects including the lead-in subjects and the study cohort
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Subjects With Procedural, Serious and Device-related Adverse Events. | Adverse events which are procedural, serious, and device-related. | Posted | Number | subjects | Procedure through 2 weeks post-procedure |
|
|
Procedure (day 0) through 2 weeks post-procedure
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphoma - death | Blood and lymphatic system disorders | Systematic Assessment | this event was not device or procedure-related |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| tube medialization | Ear and labyrinth disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director Clinical | Acclarent | 650-687-5888 | lenglan1@its.jnj.com |
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| ID | Term |
|---|---|
| D010033 | Otitis Media |
| ID | Term |
|---|---|
| D010031 | Otitis |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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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.
| Day 0 (day of procedure) |
| 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. | 2 weeks post-procedure |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| 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. | Posted | Number | devices | Day 0 (day of procedure) | devices | devices |
|
|
|
| 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. | Posted | Number | participants | Day 0 (day of procedure) |
|
|
|
| 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. | 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. | Posted | Number | participants | Day 0 (day of procedure) |
|
|
|
| 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. | 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. | Posted | Number | ears | 2 weeks post-procedure | ears | ears |
|
|
|
| 1 |
| 42 |
| 5 |
| 42 |
|
| occluded tube | Ear and labyrinth disorders | Systematic Assessment |
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| vertigo | Ear and labyrinth disorders | Systematic Assessment |
|
| mild erythema at return electrode | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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