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| Name | Class |
|---|---|
| Acclarent | INDUSTRY |
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This was a non-significant risk (NSR), prospective, multi-center, single arm clinical trial that aimed to evaluate safety and performance of the Acclarent Tympanostomy Tube Delivery System (TTDS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tympanostomy tube | Experimental | Performance and safety of tympanostomy tube delivery system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acclarent Tympanostomy Tube Delivery System (TTDS). | Device | tympanostomy tube delivery system |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ear Outcome Success | Ear Outcome Success is successful delivery of the tympanostomy tube (TT) across the tympanic membrane (TM) per ear. This endpoint was evaluated for the 13 study cohort subjects only (not the 16 lead-in subjects). | Day 0 (at procedure visit) |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure Success | Procedure Success is the successful placement of any tympanostomy tube evaluated on a per subject basis. This endpoint was evaluated for the 13 study cohort subjects only (not the 16 lead-in subjects). | Day 0 (at procedure visit) |
| Tube Retention |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kirkland | Washington | 98034 | United States |
Each investigator was required to treat a minimum of two (2) subjects as lead-in procedures prior to enrolling subjects to the test cohort.
Subjects enrolled to the lead-in cohorts were required to meet the same eligibility criteria and complete the same protocol-required procedures as the study cohort.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tympanostomy Tube | Performance and safety of tympanostomy tube delivery system Acclarent Tympanostomy Tube Delivery System (TTDS).: tympanostomy tube delivery system |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Baseline Analysis Population includes 16 lead-in subjects and 13 study cohort subjects
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| ID | Title | Description |
|---|---|---|
| BG000 | Tympanostomy Tube | Performance and safety of tympanostomy tube delivery system Acclarent Tympanostomy Tube Delivery System (TTDS).: tympanostomy tube delivery system |
| 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 | Ear Outcome Success | Ear Outcome Success is successful delivery of the tympanostomy tube (TT) across the tympanic membrane (TM) per ear. This endpoint was evaluated for the 13 study cohort subjects only (not the 16 lead-in subjects). | Posted | Number | ears | Day 0 (at procedure visit) | ears | ears |
|
|
up to 1 week post procedure
Adverse event report includes both study cohort and lead-in subjects
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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 | Performance and safety of tympanostomy tube delivery system Acclarent Tympanostomy Tube Delivery System (TTDS).: tympanostomy tube delivery system |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Occluded Tube | Ear and labyrinth disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Research | Acclarent, Inc. | 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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Tube Retention is the presence of a TTDS-placed tympanostomy tube across the tympanic membrane (TM) at the Follow-Up visit evaluated by ear. This endpoint was evaluated for the 13 study cohort subjects only (not the 16 lead-in subjects). |
| 1 week |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| ears |
|
|
| Secondary | Procedure Success | Procedure Success is the successful placement of any tympanostomy tube evaluated on a per subject basis. This endpoint was evaluated for the 13 study cohort subjects only (not the 16 lead-in subjects). | Posted | Number | participants | Day 0 (at procedure visit) |
|
|
|
| Secondary | Tube Retention | Tube Retention is the presence of a TTDS-placed tympanostomy tube across the tympanic membrane (TM) at the Follow-Up visit evaluated by ear. This endpoint was evaluated for the 13 study cohort subjects only (not the 16 lead-in subjects). | Posted | Number | ears | 1 week | ears | ears |
|
|
|
| 0 |
| 29 |
| 5 |
| 29 |
| Otalgia | Ear and labyrinth disorders | Systematic Assessment |
|
| Tube Medialization | Ear and labyrinth disorders | Systematic Assessment |
|
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