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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 Tula TDS for the placement of tympanostomy tubes under local anesthesia in an office/clinic setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tube placement group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tube Delivery System (TDS) | Device | Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system under local anesthesia in an office/clinic setting |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Procedural, Serious, and Device-Related Adverse Events | Adverse events which are procedural, serious, and device-related. | procedure up to 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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26611339 | Derived | Zeiders JW, Syms CA, Mitskavich MT, Yen DM, Harfe DT, Shields RD, Lanier BJ, Gould AR, Mouzakes J, Elliott CL. Tympanostomy tube placement in awake, unrestrained pediatric patients: A prospective, multicenter study. Int J Pediatr Otorhinolaryngol. 2015 Dec;79(12):2416-23. doi: 10.1016/j.ijporl.2015.11.003. Epub 2015 Nov 10. | |
| 26514928 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tube Placement Group | Tube Delivery System (Tula): 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 |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tube Placement Group | Tube Delivery System (Tula): Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system under local anesthesia in an office/clinic 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 | Number of Participants With Procedural, Serious, and Device-Related Adverse Events | Adverse events which are procedural, serious, and device-related. | Posted | Number | participants | procedure up to 2 weeks post procedure |
|
|
procedure 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 | Tube Placement Group | Tube Delivery System (Tula): Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system under local anesthesia in an office/clinic setting |
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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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|
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.
"Tolerability" was defined as an average post-procedure pain score (of treated ears) <= "3"
| 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 |
| Cohen LL, Martin SR, Gamwell KL, McCarty C, Shih SW. Behavioral techniques to optimize success of in-office pediatric tympanostomy tube placement without sedation. Int J Pediatr Otorhinolaryngol. 2015 Dec;79(12):2170-3. doi: 10.1016/j.ijporl.2015.09.041. Epub 2015 Oct 8. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | 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. | Analysis population includes subjects who had completed the local anesthesia procedure (iontophoresis) and in which a TDS tube delivery device was attempted. | 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. "Tolerability" was defined as an average post-procedure pain score (of treated ears) <= "3" | 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. | Only 62 of the initial 70 subjects achieved procedure success, and were present for 2 week follow-up assessment with Tula tube in situ, such that tube retention could be measured. | Posted | Number | ears | 2 weeks post procedure | ears | ears |
|
|
|
| 0 |
| 70 |
| 3 |
| 70 |
| otalgia | Ear and labyrinth disorders | Systematic Assessment |
|
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