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| Name | Class |
|---|---|
| Acclarent | INDUSTRY |
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The purpose of this study is to evaluate the performance and safety of the Tympanostomy Tube Delivery System (TTDS) for chronic otitis media or recurrent acute otitis media.
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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 |
|---|---|---|---|---|
| tympanostomy tube | Device | tympanostomy tube delivery system |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety of Tympanostomy Tube (TT) Delivery System | Occurrence of pre-defined Safety Events of acoustic trauma, deployment of the TT into the middle ear, damage to middle ear structures, unintended tympanic membrane perforation requiring treatment, abrasion to the external acoustic meatus requiring significant treatment, and major bleeding requiring significant treatment. | 7 days |
| Device Success | Device Success is defined as the successful delivery of the tympanostomy tube across the tympanic membrane using the tympanostomy tube delivery system (TTDS).Device Success is evaluated on a per device basis. | 0 days |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects With Procedure Success | Procedure Success was defined as the successful placement of any tympanostomy tube in all enrolled ears in a given subject. Non-Acclarent tubes successfully placed manually following non-success of the TTDS were counted toward Procedure Success. Procedure Success was determined on a per subject basis: the rate was calculated by the number of subjects achieving Procedure Success out of the total number of enrolled subjects. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth Faw, MD | Evergreen Sinus Center | Principal Investigator |
| Andrew Gould, MD | Advanced ENT and Allergy | Principal Investigator |
| Charles Syms, MD | Ear Medical Group | Principal Investigator |
| Jacob Zeiders, MD | South Coast ENT | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| South Coast ENT | Port Saint Lucie | Florida | 34952 | United States | ||
| Advanced ENT and Allergy |
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Eligible subjects presenting to the clinical study site for whom tympanostomy tube insertion was recommended were offered the opportunity to participate in the study by study investigators.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tympanostomy Tube Placement Using the Tube Delivery System |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tympanostomy Tube Placement Using the 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 | Safety of Tympanostomy Tube (TT) Delivery System | Occurrence of pre-defined Safety Events of acoustic trauma, deployment of the TT into the middle ear, damage to middle ear structures, unintended tympanic membrane perforation requiring treatment, abrasion to the external acoustic meatus requiring significant treatment, and major bleeding requiring significant treatment. | Subjects in whom TTDS was attempted. | Posted | Number | 95% Confidence Interval | percentage of ears | 7 days | ears | ears |
|
|
7 days
Adverse events occured only in study cohort (non lead-in) participants.
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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 | Safety Events | Safety in terms of number affected subjects in total number of subjects. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tube Lumen Occlusion | 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 |
|---|---|
| D010034 | Otitis Media with Effusion |
| D010033 | Otitis Media |
| ID | Term |
|---|---|
| D010031 | Otitis |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| D008876 | Middle Ear Ventilation |
| ID | Term |
|---|---|
| D010030 | Ostomy |
| D013514 | Surgical Procedures, Operative |
| D013506 | Otologic Surgical Procedures |
| D013517 | Otorhinolaryngologic Surgical Procedures |
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| 0 days |
| Tube Retention | Presence of the tympanostomy tube across the tympanic membrane at the follow-up visit. | 7 days |
| Louisville |
| Kentucky |
| 40207 |
| United States |
| Ear Medical Group | San Antonio | Texas | 78240 | United States |
| Evergreen Sinus Center | Kirkland | Washington | 98034 | United States |
| years |
|
| Age, Customized | Number | participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| ears |
|
|
| Primary | Device Success | Device Success is defined as the successful delivery of the tympanostomy tube across the tympanic membrane using the tympanostomy tube delivery system (TTDS).Device Success is evaluated on a per device basis. | Device Success is evaluated on a per device basis. | Posted | Number | 95% Confidence Interval | percentage of devices | 0 days | devices | devices |
|
|
|
| Secondary | Proportion of Subjects With Procedure Success | Procedure Success was defined as the successful placement of any tympanostomy tube in all enrolled ears in a given subject. Non-Acclarent tubes successfully placed manually following non-success of the TTDS were counted toward Procedure Success. Procedure Success was determined on a per subject basis: the rate was calculated by the number of subjects achieving Procedure Success out of the total number of enrolled subjects. | Posted | Number | 95% Confidence Interval | percentage of participants | 0 days |
|
|
|
| Secondary | Tube Retention | Presence of the tympanostomy tube across the tympanic membrane at the follow-up visit. | Tube retention was assessed for all TT successfully placed by the TTDS | Posted | Number | 95% Confidence Interval | percentage of tubes retained | 7 days | tympanostomy tubes placed by TTDS | tympanostomy tubes placed by TTDS |
|
|
|
| 0 |
| 53 |
| 4 |
| 53 |
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