Trial Outcomes & Findings for Acclarent Tympanostomy Tube Delivery System for the Treatment of Patients Requiring Tympanostomy Tube Insertion (NCT NCT02150044)

Last Updated: 2024-07-12

Results Overview

Ear Outcome Success is successful delivery of the tympanostomy tube (TT) across the tympanic membrane (TM) per ear. This endpoint was evaluated for the 13 study cohort subjects only (not the 16 lead-in subjects).

Recruitment status

COMPLETED

Study phase

Target enrollment

29 participants

Primary outcome timeframe

Day 0 (at procedure visit)

Results posted on

2024-07-12

Participant Flow

Each investigator was required to treat a minimum of two (2) subjects as lead-in procedures prior to enrolling subjects to the test cohort. Subjects enrolled to the lead-in cohorts were required to meet the same eligibility criteria and complete the same protocol-required procedures as the study cohort.

Participant milestones

Participant milestones
Measure	Tympanostomy Tube Performance and safety of tympanostomy tube delivery system Acclarent Tympanostomy Tube Delivery System (TTDS).: tympanostomy tube delivery system
Overall Study STARTED	29
Overall Study Lead-In Subjects	16
Overall Study Study Cohort	13
Overall Study COMPLETED	29
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Acclarent Tympanostomy Tube Delivery System for the Treatment of Patients Requiring Tympanostomy Tube Insertion

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tympanostomy Tube n=29 Participants Performance and safety of tympanostomy tube delivery system Acclarent Tympanostomy Tube Delivery System (TTDS).: tympanostomy tube delivery system
Age, Continuous	3.7 years STANDARD_DEVIATION 3.1 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants
Race (NIH/OMB) White	12 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	11 Participants n=5 Participants
Region of Enrollment United States	29 participants n=5 Participants

PRIMARY outcome

Timeframe: Day 0 (at procedure visit)

Outcome measures

Outcome measures
Measure	Tympanostomy Tube n=25 ears Performance and safety of tympanostomy tube delivery system Acclarent Tympanostomy Tube Delivery System (TTDS).: tympanostomy tube delivery system
Ear Outcome Success	21 ears

SECONDARY outcome

Timeframe: Day 0 (at procedure visit)

Procedure Success is the successful placement of any tympanostomy tube evaluated on a per subject basis. This endpoint was evaluated for the 13 study cohort subjects only (not the 16 lead-in subjects).

Outcome measures

Outcome measures
Measure	Tympanostomy Tube n=13 Participants Performance and safety of tympanostomy tube delivery system Acclarent Tympanostomy Tube Delivery System (TTDS).: tympanostomy tube delivery system
Procedure Success	12 participants

SECONDARY outcome

Timeframe: 1 week

Tube Retention is the presence of a TTDS-placed tympanostomy tube across the tympanic membrane (TM) at the Follow-Up visit evaluated by ear. This endpoint was evaluated for the 13 study cohort subjects only (not the 16 lead-in subjects).

Outcome measures

Outcome measures
Measure	Tympanostomy Tube n=21 ears Performance and safety of tympanostomy tube delivery system Acclarent Tympanostomy Tube Delivery System (TTDS).: tympanostomy tube delivery system
Tube Retention	21 ears

Adverse Events

Tympanostomy Tube

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Tympanostomy Tube n=29 participants at risk Performance and safety of tympanostomy tube delivery system Acclarent Tympanostomy Tube Delivery System (TTDS).: tympanostomy tube delivery system
Ear and labyrinth disorders Occluded Tube	6.9% 2/29 • Number of events 2 • up to 1 week post procedure Adverse event report includes both study cohort and lead-in subjects
Ear and labyrinth disorders Otalgia	3.4% 1/29 • Number of events 1 • up to 1 week post procedure Adverse event report includes both study cohort and lead-in subjects
Ear and labyrinth disorders Tube Medialization	6.9% 2/29 • Number of events 2 • up to 1 week post procedure Adverse event report includes both study cohort and lead-in subjects

Additional Information

Director of Clinical Research

Acclarent, Inc.

Phone: 650-687-5888

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60