Trial Outcomes & Findings for inVENT-visIOn Study (NCT NCT01444391)

Results Overview

Adverse events which are procedural, serious, and device-related.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

42 participants

Primary outcome timeframe

Procedure through 2 weeks post-procedure

Results posted on

2024-07-12

Participant Flow

Participant milestones

Participant milestones
Measure	Tympanostomy Tube Placement Tympanostomy tube placement (Acclarent iontophoresis device): Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system following delivery of anesthetic with Acclarent iontophoresis device
Overall Study STARTED	42
Overall Study COMPLETED	41
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Tympanostomy Tube Placement Tympanostomy tube placement (Acclarent iontophoresis device): Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system following delivery of anesthetic with Acclarent iontophoresis device
Overall Study Death	1

Baseline Characteristics

inVENT-visIOn Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tympanostomy Tube Placement n=42 Participants Tympanostomy tube placement (Acclarent iontophoresis device): Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system following delivery of anesthetic with Acclarent iontophoresis device
Age, Continuous	39.6 years STANDARD_DEVIATION 26.6 • n=93 Participants
Sex: Female, Male Female	21 Participants n=93 Participants
Sex: Female, Male Male	21 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	1 Participants n=93 Participants
Race (NIH/OMB) White	40 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=93 Participants
Region of Enrollment United States	42 participants n=93 Participants

PRIMARY outcome

Timeframe: Procedure through 2 weeks post-procedure

Adverse events which are procedural, serious, and device-related.

Outcome measures

Outcome measures
Measure	Tympanostomy Tube Placement n=42 Participants Tympanostomy tube placement (Acclarent iontophoresis device): Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system following delivery of anesthetic with Acclarent iontophoresis device
Number of Subjects With Procedural, Serious and Device-related Adverse Events.	0 subjects

PRIMARY outcome

Timeframe: Day 0 (day of procedure)

Device Success is defined as the successful delivery of the tympanostomy tube (TT) across the tympanic membrane (TM) using the Tube Delivery System(TDS). Device Success will be evaluated on a per device basis.

Outcome measures

Outcome measures
Measure	Tympanostomy Tube Placement n=63 devices Tympanostomy tube placement (Acclarent iontophoresis device): Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system following delivery of anesthetic with Acclarent iontophoresis device
Device Success	55 devices

SECONDARY outcome

Timeframe: Day 0 (day of procedure)

Procedure Success is defined as the successful placement of any tympanostomy tube in all enrolled ears in a given subject. Procedure Success is determined on a per subject basis.

Outcome measures

Outcome measures
Measure	Tympanostomy Tube Placement n=42 Participants Tympanostomy tube placement (Acclarent iontophoresis device): Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system following delivery of anesthetic with Acclarent iontophoresis device
Procedure Success	42 participants

SECONDARY outcome

Timeframe: Day 0 (day of procedure)

Population: The analysis population includes subjects with successful tube placement using the Tube Delivery System (TDS) in one or both ears. Six subjects were excluded for whom one ear had a successful TDS placement and one ear did not.

Procedure Tolerability is defined as the proportion of subjects reporting the procedure as tolerable, where tolerable is defined as a score of 0 through 3, using the Wong-Baker FACES pain scale.The Wong-Baker FACES pain scoring system is a scale of 0 to 5, where 0 means 'no hurt', 1 = 'hurts a little bit', 2 = 'hurts little more', 3 = 'hurts even more', 4 = 'hurts whole lot' and 5 = 'hurts worst'. Procedure Tolerability will be determined on a per patient basis, with the patient's score being the average of the scores for the left and right ear if both ears are successfully treated with the Tube Delivery System.

Outcome measures

Outcome measures
Measure	Tympanostomy Tube Placement n=36 Participants Tympanostomy tube placement (Acclarent iontophoresis device): Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system following delivery of anesthetic with Acclarent iontophoresis device
Procedure Tolerability	36 participants

SECONDARY outcome

Timeframe: 2 weeks post-procedure

Population: This outcome measure analysis includes evaluation only of ears with TDS-placed tube. Two subjects (3 ears) were excluded due to missing follow-up data. An additional 3 subjects (4 ears) were excluded because no TDS tube was placed. Three of the 37 participants analyzed had one of two study ears excluded, due to no TDS in that ear.

Tube retention is the presence of a tympanostomy tube placed successfully by the Tula TDS device across the tympanic membrane at the two-week follow-up visit.

Outcome measures

Outcome measures
Measure	Tympanostomy Tube Placement n=52 ears Tympanostomy tube placement (Acclarent iontophoresis device): Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system following delivery of anesthetic with Acclarent iontophoresis device
Tube Retention	52 ears

Adverse Events

Tympanostomy Tube Placement

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Tympanostomy Tube Placement n=42 participants at risk Tympanostomy tube placement (Acclarent iontophoresis device): Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system following delivery of anesthetic with Acclarent iontophoresis device
Blood and lymphatic system disorders Lymphoma - death	2.4% 1/42 • Number of events 1 • Procedure (day 0) through 2 weeks post-procedure

Other adverse events

Other adverse events
Measure	Tympanostomy Tube Placement n=42 participants at risk Tympanostomy tube placement (Acclarent iontophoresis device): Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system following delivery of anesthetic with Acclarent iontophoresis device
Ear and labyrinth disorders tube medialization	4.8% 2/42 • Number of events 2 • Procedure (day 0) through 2 weeks post-procedure
Ear and labyrinth disorders occluded tube	2.4% 1/42 • Number of events 1 • Procedure (day 0) through 2 weeks post-procedure
Ear and labyrinth disorders vertigo	2.4% 1/42 • Number of events 1 • Procedure (day 0) through 2 weeks post-procedure
Skin and subcutaneous tissue disorders mild erythema at return electrode	2.4% 1/42 • Number of events 1 • Procedure (day 0) through 2 weeks post-procedure

Additional Information

Director Clinical

Acclarent

Phone: 650-687-5888

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60