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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 (TTDS) for the placement of tympanostomy tubes (TT) under local anesthesia in an office/clinic setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tympanostomy tube placement | Experimental | placement of tympanostomy tube under local anesthesia in office/clinic setting |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acclarent Tympanostomy Tube Delivery system (TTDS) | Device | placement of tympanostomy tube under local anesthesia |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 0 |
| 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. | Day 0 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| San Antonio | Texas | 78240 | United States |
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tympanostomy Tube Placement (Lead-In Procedures) | Acclarent Tympanostomy Tube Delivery system (TTDS): Placement of tympanostomy tube under local anesthesia in office/clinic setting or under general anesthesia in operating room. |
| FG001 | Tympanostomy Tube Placement (Study Cohort) | Acclarent Tympanostomy Tube Delivery system (TTDS): Placement of tympanostomy tube under local anesthesia in office/clinic setting |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Fifty-nine (59) subjects were treated with TTDS in the office under local anesthesia, and 26 were treated with TTDS in the OR under general anesthesia.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| 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 | 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. | Posted | Number | 95% Confidence Interval | Percentage of Subjects | Day 0 |
|
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 | All enrolled subjects for which a tympanostomy tube was attempted to be placed using a Tympanostomy Tube Delivery System (TTDS). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Small Bowel Obstruction | Gastrointestinal disorders | Systematic Assessment | Not device or procedure related |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Occluded TT | 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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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 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. | 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 | Posted | Number | 95% Confidence Interval | percentage of devices | Day 0 | TTDS devices | TTDS 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. | Total in-office (IO) subjects. | Posted | Number | tubes | 14 days | tubes placed via TTDS | tubes placed via TTDS |
|
|
|
| 1 |
| 85 |
| 18 |
| 85 |
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| Otalgia | Ear and labyrinth disorders | Systematic Assessment |
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| Otitis Media | Ear and labyrinth disorders | Systematic Assessment |
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| Otorrhea | Ear and labyrinth disorders | Systematic Assessment |
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| Aural Fullness | Ear and labyrinth disorders | Systematic Assessment |
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| Vertigo | Nervous system disorders | Systematic Assessment |
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| Sinusitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | not device or procedure related |
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| Pharyngitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | not device or procedure related |
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| Gastroenteritis | Gastrointestinal disorders | Systematic Assessment | not device or procedure related |
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| Tube Medialization | Ear and labyrinth disorders | Systematic Assessment | re-positioned during procedure with no sequelae |
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