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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) in the placement of tympanostomy tubes (TTs) 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 placement | Experimental | Tympanostomy Tube Delivery System (TTDS) used for placement of tympanostomy tubes in patients indicated for such treatment for chronic Otitis Media with Effusion (OME) or recurrent Acute Otitis Media(AOM). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tympanostomy Tube Delivery System | Device | Placement of the Tympanostomy Tube by the Acclarent Tympanostomy Tube Delivery System (TTDS) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Ears Treated Successfully With the TTDS in the Absence of Acute Intraprocedural Adverse Events. | TTDS success will be confirmed by the successful delivery of a tube to the tympanic membrane. | Procedural |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Tympanostomy Tubes Extruded at 12 Months Post Procedure | 12 months | |
| Percentage of Patent Tubes | This measure assesses the patency (openness or lack of obstruction) of unextruded tubes. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Henry Tan, MD | KK Women's and Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KK Women's and Children's Hospital Singapore | Singapore | Singapore |
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Consecutive eligible patients presenting to the study site and for whom tube insertion was recommended were offered the opportunity by the investigator to participate in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tympanic Tube Placement | Tympanostomy Tube Delivery System (TTDS) in the placement of tympanostomy tubes in patients indicated for such treatment for chronic Otitis Media with Effusion (OME) or recurrent Acute Otitis Media(AOM). Tympanostomy Tube Delivery System: Placement of the Tympanostomy Tube by the Acclarent Tympanostomy Tube Delivery System (TTDS) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tympanic Tube Placement | Tympanostomy Tube Delivery System (TTDS) in the placement of tympanostomy tubes in patients indicated for such treatment for chronic Otitis Media with Effusion (OME) or recurrent Acute Otitis Media(AOM). Tympanostomy Tube Delivery System: Placement of the Tympanostomy Tube by the Acclarent Tympanostomy Tube Delivery System (TTDS) |
| 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 Ears Treated Successfully With the TTDS in the Absence of Acute Intraprocedural Adverse Events. | TTDS success will be confirmed by the successful delivery of a tube to the tympanic membrane. | One subject was missing data on intraprocedural adverse events and is excluded from this analysis. | Posted | Number | 95% Confidence Interval | percentage of ears | Procedural | ears | ears |
|
Final follow-up visit was the earlier of 24 months post-procedure or 12 months after tube extrusion.
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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 | Tympanic Tube Placement | Tympanostomy Tube Delivery System (TTDS) in the placement of tympanostomy tubes in patients indicated for such treatment for chronic Otitis Media with Effusion (OME) or recurrent Acute Otitis Media(AOM). Tympanostomy Tube Delivery System: Placement of the Tympanostomy Tube by the Acclarent Tympanostomy Tube Delivery System (TTDS) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| occluded tube/blood in ear | Ear and labyrinth disorders | Systematic Assessment | Subject presented with blood in ear and a case of influenza |
The protocol called for outcome measure assessing patency (openness/lack of obstruction) of unextruded tubes at 12 mos post procedure. Since all tubes had already been extruded by 12 mos, no ears with tubes remained for assessment and it was omitted.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Research | Acclarent | 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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|
| 30 days |
| Percentage of Patent Tubes | This measure assesses the patency (openness or lack of obstruction) of unextruded tubes. | 3 months |
| Percentage of Patent Tubes | This measure assesses the patency (openness or lack of obstruction) of unextruded tubes. | 6 months |
| Percentage of Patent Tubes | This measure assesses the patency (openness or lack of obstruction) of unextruded tubes. | 9 Months |
| Percentage of Ears With Adverse Events | This outcome measure evaluates occurrence of new adverse events since prior follow-up visit. (non-cumulative) | 30 days |
| Percentage of Ears With Adverse Events | This outcome measure evaluates occurrence of new adverse events since prior follow-up visit. (non-cumulative) | 3 months |
| Percentage of Ears With Adverse Events | This outcome measure evaluates occurrence of new adverse events since prior follow-up visit. (non-cumulative) | 6 months |
| Percentage of Ears With Adverse Events | This outcome measure evaluates occurrence of new adverse events since prior follow-up visit. (non-cumulative) | 9 months |
| Percentage of Ears With Adverse Events | This outcome measure evaluates occurrence of new adverse events since prior follow-up visit. (non-cumulative) | 12 months post procedure |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
|
| ears |
|
|
| Secondary | Percentage of Tympanostomy Tubes Extruded at 12 Months Post Procedure | Over the course of 12 months, a total of 17 subjects (25 ears) were assessed at varying follow-up time points as having had tubes extruded. Ears analyzed included those for which a tube was observed to extrude at any follow-up visit and ears that completed the 12 month visit. | Posted | Number | 95% Confidence Interval | percentage of tubes | 12 months | tubes | tubes |
|
|
|
| Secondary | Percentage of Patent Tubes | This measure assesses the patency (openness or lack of obstruction) of unextruded tubes. | One subject (one ear) was lost to follow-up immediately following the procedure. | Posted | Number | 95% Confidence Interval | percentage of tubes | 30 days | tubes | tubes |
|
|
|
| Secondary | Percentage of Patent Tubes | This measure assesses the patency (openness or lack of obstruction) of unextruded tubes. | Two subjects were lost to follow-up after the 30 day visit and one subject missed the 3 month visit. One subject was lost to follow-up immediately following the procedure. Thus, only 28 ears of 21 participants had unextruded tubes for assessment of tube patency. | Posted | Number | 95% Confidence Interval | percentage of tubes | 3 months | tubes | tubes |
|
|
|
| Secondary | Percentage of Patent Tubes | This measure assesses the patency (openness or lack of obstruction) of unextruded tubes. | Two subjects lost to follow-up after 3 month visit. Two subjects missed 6 month visit. Two subjects lost to follow-up after 30 day visit. One subject lost to follow-up immediately following procedure. Thus, only 13 ears (= 9 participants) of 18 participants returning at 6 months had unextruded tubes for assessment of patency. | Posted | Number | 95% Confidence Interval | percentage of tubes | 6 months | tubes | tubes |
|
|
|
| Secondary | Percentage of Patent Tubes | This measure assesses the patency (openness or lack of obstruction) of unextruded tubes. | 3 subjects lost to follow-up after 6 mo visit. 1 subject missed 9 mo visit. 2 subjects lost to follow-up after 3 mo visit. 2 subjects lost to follow-up after 30 day visit. 1 subject lost to follow-up following procedure. Thus, only 3 ears (= 3 participants) of 16 participants returning at 9 mos had unextruded tubes for assessment of patency. | Posted | Number | 95% Confidence Interval | percentage of tubes | 9 Months | tubes | tubes |
|
|
|
| Secondary | Percentage of Ears With Adverse Events | This outcome measure evaluates occurrence of new adverse events since prior follow-up visit. (non-cumulative) | One subject was lost to follow-up immediately following the procedure. | Posted | Number | 95% Confidence Interval | percentage of ears | 30 days | ears | ears |
|
|
|
| Secondary | Percentage of Ears With Adverse Events | This outcome measure evaluates occurrence of new adverse events since prior follow-up visit. (non-cumulative) | One subject was lost to follow-up immediately following the procedure. Two additional subjects were lost to follow-up after the 30 day visit and one subject missed the 30 day visit. | Posted | Number | 95% Confidence Interval | percentage of ears | 3 months | ears | ears |
|
|
|
| Secondary | Percentage of Ears With Adverse Events | This outcome measure evaluates occurrence of new adverse events since prior follow-up visit. (non-cumulative) | One subject was lost to follow-up immediately following the procedure. Two subjects were lost to follow-up after the 30 day visit. Two additional subjects were lost to follow-up after the 3 month visit and two subject missed the 3 month visit. | Posted | Number | 95% Confidence Interval | percentage of ears | 6 months | ears | ears |
|
|
|
| Secondary | Percentage of Ears With Adverse Events | This outcome measure evaluates occurrence of new adverse events since prior follow-up visit. (non-cumulative) | One subject was lost to follow-up immediately following the procedure. Two subjects were lost to follow-up after the 30 day visit. Two subjects were lost to follow-up after the 3 month visit. Three additional subjects were lost to follow-up following the 6 month visit and one subject missed the 9 month visit. | Posted | Number | 95% Confidence Interval | percentage of ears | 9 months | ears | ears |
|
|
|
| Secondary | Percentage of Ears With Adverse Events | This outcome measure evaluates occurrence of new adverse events since prior follow-up visit. (non-cumulative) | One subject was lost to follow-up following the procedure. 2 subjects were lost to follow-up after the 30 day visit. 2 subjects were lost to follow-up after the 3 month visit. 3 subjects were lost to follow-up following the 6 month visit. 4 subjects were lost to follow-up after the 9 month visit and 2 subjects missed the 12 month visit. | Posted | Number | 95% Confidence Interval | percentage of ears | 12 months post procedure | ears | ears |
|
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|
| 0 |
| 25 |
| 1 |
| 25 |
|
| influenza | Infections and infestations | Systematic Assessment |
|
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