Trial Outcomes & Findings for Clinical Study of the Tympanostomy Tube Delivery System (NCT NCT00939796)

Results Overview

Successful deployment of the tube in each indicated ear using the TTDS. Evaluated for test cohort subjects only (not lead-in subjects).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

16 participants

Primary outcome timeframe

At procedure visit

Results posted on

2024-08-06

Participant Flow

Eligible patients presenting to the clinical practice and for whom tympanostomy tube (TT) insertion was recommended were offered the opportunity to participate in the study. Recruitment period was May-June 2009.

Investigators treated a minimum of 1 subject (or 2 ears) as lead-in procedures prior to enrolling test cohort. 3 lead-in subjects were enrolled and were required to meet the same eligibility criteria and protocol-required procedures as the test cohort. Lead-in efficacy data have been separately analyzed. 13 subjects enrolled in the test cohort.

Participant milestones

Participant milestones
Measure	Tympanostomy Tube Delivery System (TTDS) Tympanostomy tube placement with Acclarent tube delivery system
Overall Study STARTED	16
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Study of the Tympanostomy Tube Delivery System

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tympanostomy Tube Delivery System (TTDS) n=16 Participants Tympanostomy tube placement with Acclarent tube delivery system
Age, Customized <=5 years	14 participants n=5 Participants
Age, Customized >5 years	2 participants n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Region of Enrollment United States	16 participants n=5 Participants

PRIMARY outcome

Timeframe: At procedure visit

Population: All TTDS devices attempted

Successful deployment of the tube in each indicated ear using the TTDS. Evaluated for test cohort subjects only (not lead-in subjects).

Outcome measures

Outcome measures
Measure	Tympanostomy Tube Delivery System (TTDS) n=26 devices Tympanostomy tube placement with Acclarent tube delivery system
Device Success	21 devices

SECONDARY outcome

Timeframe: at procedure visit

Conversion of the procedure from Tympanostomy Tube Delivery System to manual myringotomy and tube placement. Evaluated for test cohort subjects only (not lead-in subjects). Decision to convert to a manual myringotomy and tube placement procedure occurs at the conclusion of the Tube Delivery System procedure.

Outcome measures

Outcome measures
Measure	Tympanostomy Tube Delivery System (TTDS) n=24 ears attempted Tympanostomy tube placement with Acclarent tube delivery system
Cross-Over to Manual Myringotomy and Tube Placement	3 number of ears

SECONDARY outcome

Timeframe: two weeks post-procedure

Presence of the Tympanostomy Tube across the tympanic membrane at two weeks post-procedure. Evaluated for test cohort subjects only (not lead-in subjects).

Outcome measures

Outcome measures
Measure	Tympanostomy Tube Delivery System (TTDS) n=24 retained tubes Tympanostomy tube placement with Acclarent tube delivery system
Tube Retention	24 retained tubes

Adverse Events

Tympanostomy Tube Delivery System (TTDS)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Tympanostomy Tube Delivery System (TTDS) n=16 participants at risk Tympanostomy tube placement with Acclarent tube delivery system
Ear and labyrinth disorders tympanic membrane perforation	12.5% 2/16 • Number of events 2 • 2 weeks

Additional Information

Director of Clinical Research

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