Otitis Media
Conditions
Brief summary
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).
Interventions
DEVICETympanostomy Tube Delivery System
Placement of the Tympanostomy Tube by the Acclarent Tympanostomy Tube Delivery System (TTDS)
Sponsors
Acclarent
Integra LifeSciences Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. \>= 1 year of age 2. Diagnosed with either Chronic Otitis Media with Effusion or recurrent Acute Otitis Media and scheduled to undergo bilateral or unilateral tympanostomy tube insertion. 3. Either male or female -
Exclusion criteria
1. History of sensitivity or reaction to anaesthesia 2. Markedly atrophic, retracted, atelectatic or perforated tympanic membrane. 3. Otitis externa 4. Active acute otitis media 5. Thickened Tympanic Membrane 6. Thick mucoid effusion (also known as glue ear) 7. Otitis media pathology requiring T-tubes -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Ears Treated Successfully With the TTDS in the Absence of Acute Intraprocedural Adverse Events. | Procedural | TTDS success will be confirmed by the successful delivery of a tube to the tympanic membrane. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Tympanostomy Tubes Extruded at 12 Months Post Procedure | 12 months | — |
| Percentage of Patent Tubes | 30 days | This measure assesses the patency (openness or lack of obstruction) of unextruded tubes. |
| Percentage of Ears With Adverse Events | 30 days | This outcome measure evaluates occurrence of new adverse events since prior follow-up visit. (non-cumulative) |
Countries
Singapore
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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) | 25 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Exited voluntarily after tube extrusion | 11 |
| Overall Study | Exited voluntarily before tube extrusion | 7 |
Baseline characteristics
| Characteristic | Tympanic Tube Placement |
|---|---|
| Age, Continuous | 5.5 years STANDARD_DEVIATION 2.7 |
| Region of Enrollment Singapore | 25 participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 25 |
| serious Total, serious adverse events | 0 / 25 |
Outcome results
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.
Time frame: Procedural
Population: One subject was missing data on intraprocedural adverse events and is excluded from this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tympanic Tube Placement | Percentage of Ears Treated Successfully With the TTDS in the Absence of Acute Intraprocedural Adverse Events. | 94.6 percentage of ears |
Secondary
Percentage of Ears With Adverse Events
This outcome measure evaluates occurrence of new adverse events since prior follow-up visit. (non-cumulative)
Time frame: 6 months
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tympanic Tube Placement | Percentage of Ears With Adverse Events | 0.0 percentage of ears |
Secondary
Percentage of Ears With Adverse Events
This outcome measure evaluates occurrence of new adverse events since prior follow-up visit. (non-cumulative)
Time frame: 3 months
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tympanic Tube Placement | Percentage of Ears With Adverse Events | 3.0 percentage of ears |
Secondary
Percentage of Ears With Adverse Events
This outcome measure evaluates occurrence of new adverse events since prior follow-up visit. (non-cumulative)
Time frame: 30 days
Population: One subject was lost to follow-up immediately following the procedure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tympanic Tube Placement | Percentage of Ears With Adverse Events | 2.9 percentage of ears |
Secondary
Percentage of Ears With Adverse Events
This outcome measure evaluates occurrence of new adverse events since prior follow-up visit. (non-cumulative)
Time frame: 9 months
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tympanic Tube Placement | Percentage of Ears With Adverse Events | 0.0 percentage of ears |
Secondary
Percentage of Ears With Adverse Events
This outcome measure evaluates occurrence of new adverse events since prior follow-up visit. (non-cumulative)
Time frame: 12 months post procedure
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tympanic Tube Placement | Percentage of Ears With Adverse Events | 0.0 percentage of ears |
Secondary
Percentage of Patent Tubes
This measure assesses the patency (openness or lack of obstruction) of unextruded tubes.
Time frame: 6 months
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tympanic Tube Placement | Percentage of Patent Tubes | 100 percentage of tubes |
Secondary
Percentage of Patent Tubes
This measure assesses the patency (openness or lack of obstruction) of unextruded tubes.
Time frame: 9 Months
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tympanic Tube Placement | Percentage of Patent Tubes | 100 percentage of tubes |
Secondary
Percentage of Patent Tubes
This measure assesses the patency (openness or lack of obstruction) of unextruded tubes.
Time frame: 30 days
Population: One subject (one ear) was lost to follow-up immediately following the procedure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tympanic Tube Placement | Percentage of Patent Tubes | 94.6 percentage of tubes |
Secondary
Percentage of Patent Tubes
This measure assesses the patency (openness or lack of obstruction) of unextruded tubes.
Time frame: 3 months
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tympanic Tube Placement | Percentage of Patent Tubes | 100 percentage of tubes |
Secondary
Percentage of Tympanostomy Tubes Extruded at 12 Months Post Procedure
Time frame: 12 months
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tympanic Tube Placement | Percentage of Tympanostomy Tubes Extruded at 12 Months Post Procedure | 100 percentage of tubes |