Trial Outcomes & Findings for Evaluation of the Tympanostomy Tube Delivery System (NCT NCT01202578)

Results Overview

Occurrence of pre-defined Safety Events of acoustic trauma, deployment of the TT into the middle ear, damage to middle ear structures, unintended tympanic membrane perforation requiring treatment, abrasion to the external acoustic meatus requiring significant treatment, and major bleeding requiring significant treatment.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

53 participants

Primary outcome timeframe

7 days

Results posted on

2024-08-06

Participant Flow

Eligible subjects presenting to the clinical study site for whom tympanostomy tube insertion was recommended were offered the opportunity to participate in the study by study investigators.

Participant milestones

Participant milestones
Measure	Tympanostomy Tube Placement Using the Tube Delivery System
Overall Study STARTED	53
Overall Study COMPLETED	53
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of the Tympanostomy Tube Delivery System

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tympanostomy Tube Placement Using the Tube Delivery System n=53 Participants
Age, Continuous	2.68 years STANDARD_DEVIATION 2.49 • n=5 Participants
Age, Customized <=5 years	47 participants n=5 Participants
Age, Customized >5 years	6 participants n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants
Sex: Female, Male Male	31 Participants n=5 Participants
Region of Enrollment United States	53 participants n=5 Participants

PRIMARY outcome

Timeframe: 7 days

Population: Subjects in whom TTDS was attempted.

Occurrence of pre-defined Safety Events of acoustic trauma, deployment of the TT into the middle ear, damage to middle ear structures, unintended tympanic membrane perforation requiring treatment, abrasion to the external acoustic meatus requiring significant treatment, and major bleeding requiring significant treatment.

Outcome measures

Outcome measures
Measure	Tympanostomy Tube Placement Using the Tube Delivery System n=101 ears
Safety of Tympanostomy Tube (TT) Delivery System	0.0 percentage of ears Interval 0.0 to 3.6

PRIMARY outcome

Timeframe: 0 days

Population: Device Success is evaluated on a per device basis.

Device Success is defined as the successful delivery of the tympanostomy tube across the tympanic membrane using the tympanostomy tube delivery system (TTDS).Device Success is evaluated on a per device basis.

Outcome measures

Outcome measures
Measure	Tympanostomy Tube Placement Using the Tube Delivery System n=101 devices
Device Success	94.1 percentage of devices Interval 87.5 to 97.8

SECONDARY outcome

Timeframe: 0 days

Procedure Success was defined as the successful placement of any tympanostomy tube in all enrolled ears in a given subject. Non-Acclarent tubes successfully placed manually following non-success of the TTDS were counted toward Procedure Success. Procedure Success was determined on a per subject basis: the rate was calculated by the number of subjects achieving Procedure Success out of the total number of enrolled subjects.

Outcome measures

Outcome measures
Measure	Tympanostomy Tube Placement Using the Tube Delivery System n=53 Participants
Proportion of Subjects With Procedure Success	100 percentage of participants Interval 93.3 to 100.0

SECONDARY outcome

Timeframe: 7 days

Population: Tube retention was assessed for all TT successfully placed by the TTDS

Presence of the tympanostomy tube across the tympanic membrane at the follow-up visit.

Outcome measures

Outcome measures
Measure	Tympanostomy Tube Placement Using the Tube Delivery System n=95 tympanostomy tubes placed by TTDS
Tube Retention	99.0 percentage of tubes retained Interval 94.3 to 100.0

Adverse Events

Safety Events

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Safety Events n=53 participants at risk Safety in terms of number affected subjects in total number of subjects.
Ear and labyrinth disorders Tube Lumen Occlusion	7.5% 4/53 • Number of events 5 • 7 days Adverse events occured only in study cohort (non lead-in) participants.

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