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| Name | Class |
|---|---|
| Acclarent | INDUSTRY |
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The objective of this investigational study is to evaluate the safety and performance of the Acclarent Tympanostomy Tube Delivery System (TTDS) for the placement of the Tympanostomy Tube [TT(s)] in patients indicated for such treatment for chronic otitis media with effusion (OME) or recurrent acute otitis media (AOM).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tympanostomy Tube Delivery System (TTDS) | Experimental | Tympanostomy tube placement with Acclarent tube delivery system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acclarent Tympanostomy Tube Delivery System | Device | A device which provides a means to create a myringotomy with insertion of a proloaded tympanostomy tube (TT) for placement of the TT in patients indicated for such treatment for Otitis Media |
| Measure | Description | Time Frame |
|---|---|---|
| Device Success | Successful deployment of the tube in each indicated ear using the TTDS. Evaluated for test cohort subjects only (not lead-in subjects). | At procedure visit |
| Measure | Description | Time Frame |
|---|---|---|
| Cross-Over to Manual Myringotomy and Tube Placement | Conversion of the procedure from Tympanostomy Tube Delivery System to manual myringotomy and tube placement. Evaluated for test cohort subjects only (not lead-in subjects). Decision to convert to a manual myringotomy and tube placement procedure occurs at the conclusion of the Tube Delivery System procedure. | at procedure visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charles Syms, III, MD | Ear Medical Group | Principal Investigator |
| Charles Wilson, MD | Bay Area ENT | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bay Area ENT | Biloxi | Mississippi | 39532 | United States | ||
| Ear Medical Group |
Investigators treated a minimum of 1 subject (or 2 ears) as lead-in procedures prior to enrolling test cohort. 3 lead-in subjects were enrolled and were required to meet the same eligibility criteria and protocol-required procedures as the test cohort. Lead-in efficacy data have been separately analyzed. 13 subjects enrolled in the test cohort.
Eligible patients presenting to the clinical practice and for whom tympanostomy tube (TT) insertion was recommended were offered the opportunity to participate in the study. Recruitment period was May-June 2009.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tympanostomy Tube Delivery System (TTDS) | Tympanostomy tube placement with Acclarent tube delivery system |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tympanostomy Tube Delivery System (TTDS) | Tympanostomy tube placement with Acclarent 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, Customized | Number |
| 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 | Device Success | Successful deployment of the tube in each indicated ear using the TTDS. Evaluated for test cohort subjects only (not lead-in subjects). | All TTDS devices attempted | Posted | Number | devices | At procedure visit | devices | devices |
|
|
2 weeks
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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 Delivery System (TTDS) | Tympanostomy tube placement with Acclarent tube delivery system |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| tympanic membrane perforation | Ear and labyrinth disorders | Systematic Assessment | In the Lead-In cohort: Unintended TM perforations occurred in 2 of 6 ears recorded as non-serious device-related adverse events, with no sequelae. There were no SAEs. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Research | Acclarent | 650-687-5888 | lenglan1@its.jnj.com |
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| ID | Term |
|---|---|
| D010034 | Otitis Media with Effusion |
| ID | Term |
|---|---|
| D010033 | Otitis Media |
| D010031 | Otitis |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| Tube Retention | Presence of the Tympanostomy Tube across the tympanic membrane at two weeks post-procedure. Evaluated for test cohort subjects only (not lead-in subjects). | two weeks post-procedure |
| San Antonio |
| Texas |
| 78240 |
| United States |
| participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| devices |
|
|
| Secondary | Cross-Over to Manual Myringotomy and Tube Placement | Conversion of the procedure from Tympanostomy Tube Delivery System to manual myringotomy and tube placement. Evaluated for test cohort subjects only (not lead-in subjects). Decision to convert to a manual myringotomy and tube placement procedure occurs at the conclusion of the Tube Delivery System procedure. | Posted | Number | number of ears | at procedure visit | ears attempted | ears attempted |
|
|
|
| Secondary | Tube Retention | Presence of the Tympanostomy Tube across the tympanic membrane at two weeks post-procedure. Evaluated for test cohort subjects only (not lead-in subjects). | Posted | Number | retained tubes | two weeks post-procedure | retained tubes | retained tubes |
|
|
|
| 0 |
| 16 |
| 2 |
| 16 |
|
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