Otitis Media With Effusion
Conditions
Brief summary
The objective of this investigational study is to evaluate the safety and performance of the Acclarent Tympanostomy Tube Delivery System (TTDS) for the placement of the Tympanostomy Tube \[TT(s)\] in patients indicated for such treatment for chronic otitis media with effusion (OME) or recurrent acute otitis media (AOM).
Interventions
DEVICEAcclarent Tympanostomy Tube Delivery System
A device which provides a means to create a myringotomy with insertion of a proloaded tympanostomy tube (TT) for placement of the TT in patients indicated for such treatment for Otitis Media
Sponsors
Acclarent
Integra LifeSciences Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
1. Patients scheduled to undergo bilateral or unilateral tympanostomy tube insertion. 2. Either male or female
Exclusion criteria
1. History of sensitivity or reaction to anesthesia chosen for the procedure 2. Markedly atrophic, mono- or bimeric, severely retracted, atelectatic or perforated tympanic membrane 3. Otitis externa 4. Active acute otitis media 5. Otitis media pathology 6. Stenosed ear canal
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device Success | At procedure visit | Successful deployment of the tube in each indicated ear using the TTDS. Evaluated for test cohort subjects only (not lead-in subjects). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cross-Over to Manual Myringotomy and Tube Placement | 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. |
| Tube Retention | 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). |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Tympanostomy Tube Delivery System (TTDS) Tympanostomy tube placement with Acclarent tube delivery system | 16 |
| Total | 16 |
Baseline characteristics
| Characteristic | Tympanostomy Tube Delivery System (TTDS) |
|---|---|
| Age, Customized <=5 years | 14 participants |
| Age, Customized >5 years | 2 participants |
| Region of Enrollment United States | 16 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 2 / 16 |
| serious Total, serious adverse events | 0 / 16 |
Outcome results
Primary
Device Success
Successful deployment of the tube in each indicated ear using the TTDS. Evaluated for test cohort subjects only (not lead-in subjects).
Time frame: At procedure visit
Population: All TTDS devices attempted
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tympanostomy Tube Delivery System (TTDS) | Device Success | 21 devices |
Secondary
Cross-Over to Manual Myringotomy and Tube Placement
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.
Time frame: at procedure visit
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tympanostomy Tube Delivery System (TTDS) | Cross-Over to Manual Myringotomy and Tube Placement | 3 number of ears |
Secondary
Tube Retention
Presence of the Tympanostomy Tube across the tympanic membrane at two weeks post-procedure. Evaluated for test cohort subjects only (not lead-in subjects).
Time frame: two weeks post-procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tympanostomy Tube Delivery System (TTDS) | Tube Retention | 24 retained tubes |