Trial Outcomes & Findings for Singapore Tympanostomy Tube Delivery System Study (NCT NCT01046877)

Results Overview

TTDS success will be confirmed by the successful delivery of a tube to the tympanic membrane.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

25 participants

Primary outcome timeframe

Procedural

Results posted on

2024-08-06

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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)
Overall Study STARTED	25
Overall Study Completed on Schedule	6
Overall Study Completed Study Late	1
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	18

Reasons for withdrawal

Reasons for withdrawal
Measure	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)
Overall Study Exited voluntarily before tube extrusion	7
Overall Study Exited voluntarily after tube extrusion	11

Baseline Characteristics

Singapore Tympanostomy Tube Delivery System Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tympanic Tube Placement n=25 Participants 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)
Age, Continuous	5.5 years STANDARD_DEVIATION 2.7 • n=93 Participants
Sex: Female, Male Female	12 Participants n=93 Participants
Sex: Female, Male Male	13 Participants n=93 Participants
Region of Enrollment Singapore	25 participants n=93 Participants

PRIMARY outcome

Timeframe: Procedural

Population: One subject was missing data on intraprocedural adverse events and is excluded from this analysis.

TTDS success will be confirmed by the successful delivery of a tube to the tympanic membrane.

Outcome measures

Outcome measures
Measure	Tympanic Tube Placement n=37 ears 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)
Percentage of Ears Treated Successfully With the TTDS in the Absence of Acute Intraprocedural Adverse Events.	94.6 percentage of ears Interval 81.8 to 99.3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Tympanic Tube Placement n=25 tubes 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)
Percentage of Tympanostomy Tubes Extruded at 12 Months Post Procedure	100 percentage of tubes Interval 86.3 to 100.0

SECONDARY outcome

Timeframe: 30 days

Population: One subject (one ear) was lost to follow-up immediately following the procedure.

This measure assesses the patency (openness or lack of obstruction) of unextruded tubes.

Outcome measures

Outcome measures
Measure	Tympanic Tube Placement n=37 tubes 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)
Percentage of Patent Tubes	94.6 percentage of tubes Interval 81.8 to 99.3

SECONDARY outcome

Timeframe: 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.

This measure assesses the patency (openness or lack of obstruction) of unextruded tubes.

Outcome measures

Outcome measures
Measure	Tympanic Tube Placement n=28 tubes 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)
Percentage of Patent Tubes	100 percentage of tubes Interval 87.7 to 100.0

SECONDARY outcome

Timeframe: 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.

This measure assesses the patency (openness or lack of obstruction) of unextruded tubes.

Outcome measures

Outcome measures
Measure	Tympanic Tube Placement n=13 tubes 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)
Percentage of Patent Tubes	100 percentage of tubes Interval 75.3 to 100.0

SECONDARY outcome

Timeframe: 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.

This measure assesses the patency (openness or lack of obstruction) of unextruded tubes.

Outcome measures

Outcome measures
Measure	Tympanic Tube Placement n=3 tubes 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)
Percentage of Patent Tubes	100 percentage of tubes Interval 29.2 to 100.0