Trial Outcomes & Findings for Tympanostomy Tube Placement in Children in the Office (Inova Study) (NCT NCT01496287)

NCT ID: NCT01496287

Last Updated: 2024-08-06

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 70 participants
• Primary outcome timeframe: procedure up to 2 weeks post procedure
• Results posted on: 2024-08-06

Participant Flow

Participant milestones

Measure	Tube Placement Group Tube Delivery System (Tula): Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system following delivery of anesthetic with Acclarent iontophoresis device
Overall Study STARTED	70
Overall Study COMPLETED	64
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Measure	Tube Placement Group Tube Delivery System (Tula): Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system following delivery of anesthetic with Acclarent iontophoresis device
Overall Study Lost to Follow-up	1
Overall Study Incomplete anesthesia	5

Baseline Characteristics

Tympanostomy Tube Placement in Children in the Office (Inova Study)

Baseline characteristics by cohort

Measure	Tube Placement Group n=70 Participants Tube Delivery System (Tula): Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system under local anesthesia in an office/clinic setting
Age, Continuous	7.0 years STANDARD_DEVIATION 3.9 • n=5 Participants
Sex: Female, Male Female	36 Participants n=5 Participants
Sex: Female, Male Male	34 Participants n=5 Participants
Race/Ethnicity, Customized African American or Black	5 participants n=5 Participants
Race/Ethnicity, Customized Asian	1 participants n=5 Participants
Race/Ethnicity, Customized White	47 participants n=5 Participants
Race/Ethnicity, Customized Other or Unknown	17 participants n=5 Participants
Region of Enrollment United States	70 participants n=5 Participants

PRIMARY outcome

Timeframe: procedure up to 2 weeks post procedure

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

Outcome measures

Measure	Tube Placement Group n=70 Participants Tube Delivery System (Tula): Placement of tympanostomy tube by the tympanostomy tube delivery system under local anesthesia in an office/clinic setting
Number of Participants With Procedural, Serious, and Device-Related Adverse Events	0 participants

PRIMARY outcome

Timeframe: Day 0 (day of procedure)

Population: Analysis population includes subjects who had completed the local anesthesia procedure (iontophoresis) and in which a TDS tube delivery device was attempted.

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

Measure	Tube Placement Group n=128 devices Tube Delivery System (Tula): Placement of tympanostomy tube by the tympanostomy tube delivery system under local anesthesia in an office/clinic setting
Device Success	114 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

Measure	Tube Placement Group n=70 Participants Tube Delivery System (Tula): Placement of tympanostomy tube by the tympanostomy tube delivery system under local anesthesia in an office/clinic setting
Procedure Success	63 participants

SECONDARY outcome

Timeframe: Day 0 (day of procedure)

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.

"Tolerability" was defined as an average post-procedure pain score (of treated ears) <= "3"

Outcome measures

Measure	Tube Placement Group n=64 Participants Tube Delivery System (Tula): Placement of tympanostomy tube by the tympanostomy tube delivery system under local anesthesia in an office/clinic setting
Procedure Tolerability	59 participants

SECONDARY outcome

Timeframe: 2 weeks post procedure

Population: Only 62 of the initial 70 subjects achieved procedure success, and were present for 2 week follow-up assessment with Tula tube in situ, such that tube retention could be measured.

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

Measure	Tube Placement Group n=112 ears Tube Delivery System (Tula): Placement of tympanostomy tube by the tympanostomy tube delivery system under local anesthesia in an office/clinic setting
Tube Retention	111 ears

Adverse Events

Tube Placement Group

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Tube Placement Group n=70 participants at risk Tube Delivery System (Tula): Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system under local anesthesia in an office/clinic setting
Ear and labyrinth disorders occluded tube	2.9% 2/70 • Number of events 2 • procedure through 2 weeks post-procedure
Ear and labyrinth disorders otalgia	1.4% 1/70 • Number of events 1 • procedure through 2 weeks post-procedure

Additional Information

Director of Clinical Research

Acclarent, Inc.

Phone: 650-687-5888

Email: lenglan1@its.jnj.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60