Otitis Media
Conditions
Brief summary
This was a non-significant risk (NSR), prospective, multi-center, single arm clinical trial that aimed to evaluate safety and performance of the Acclarent Tympanostomy Tube Delivery System (TTDS).
Interventions
DEVICEAcclarent Tympanostomy Tube Delivery System (TTDS).
tympanostomy tube delivery system
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
* Diagnosed with either chronic otitis media with effusion (OME) or recurrent acute otitis media (AOM) and scheduled to undergo tympanostomy tube insertion
Exclusion criteria
* History of sensitivity or reaction to anesthesia chosen for the procedure * Markedly atrophic, mono- or bimeric, severely retracted, atelectatic or perforated tympanic membrane * Otitis externa * Active acute otitis media * Otitis media pathology requiring T-tubes * Stenosed ear canal * Anatomy that precludes sufficient visualization of and access to the tympanic membrane * Anatomy that necessitates tympanostomy tube placement in the posterior half of the tympanic membrane
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ear Outcome Success | Day 0 (at procedure visit) | Ear Outcome Success is successful delivery of the tympanostomy tube (TT) across the tympanic membrane (TM) per ear. This endpoint was evaluated for the 13 study cohort subjects only (not the 16 lead-in subjects). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedure Success | Day 0 (at procedure visit) | Procedure Success is the successful placement of any tympanostomy tube evaluated on a per subject basis. This endpoint was evaluated for the 13 study cohort subjects only (not the 16 lead-in subjects). |
| Tube Retention | 1 week | Tube Retention is the presence of a TTDS-placed tympanostomy tube across the tympanic membrane (TM) at the Follow-Up visit evaluated by ear. This endpoint was evaluated for the 13 study cohort subjects only (not the 16 lead-in subjects). |
Countries
United States
Participant flow
Pre-assignment details
Each investigator was required to treat a minimum of two (2) subjects as lead-in procedures prior to enrolling subjects to the test cohort. Subjects enrolled to the lead-in cohorts were required to meet the same eligibility criteria and complete the same protocol-required procedures as the study cohort.
Participants by arm
| Arm | Count |
|---|---|
| Tympanostomy Tube Performance and safety of tympanostomy tube delivery system
Acclarent Tympanostomy Tube Delivery System (TTDS).: tympanostomy tube delivery system | 29 |
| Total | 29 |
Baseline characteristics
| Characteristic | Tympanostomy Tube |
|---|---|
| Age, Continuous | 3.7 years STANDARD_DEVIATION 3.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 11 Participants |
| Race (NIH/OMB) White | 12 Participants |
| Region of Enrollment United States | 29 participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 5 / 29 |
| serious Total, serious adverse events | 0 / 29 |
Outcome results
Primary
Ear Outcome Success
Ear Outcome Success is successful delivery of the tympanostomy tube (TT) across the tympanic membrane (TM) per ear. This endpoint was evaluated for the 13 study cohort subjects only (not the 16 lead-in subjects).
Time frame: Day 0 (at procedure visit)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tympanostomy Tube | Ear Outcome Success | 21 ears |
Secondary
Procedure Success
Procedure Success is the successful placement of any tympanostomy tube evaluated on a per subject basis. This endpoint was evaluated for the 13 study cohort subjects only (not the 16 lead-in subjects).
Time frame: Day 0 (at procedure visit)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tympanostomy Tube | Procedure Success | 12 participants |
Secondary
Tube Retention
Tube Retention is the presence of a TTDS-placed tympanostomy tube across the tympanic membrane (TM) at the Follow-Up visit evaluated by ear. This endpoint was evaluated for the 13 study cohort subjects only (not the 16 lead-in subjects).
Time frame: 1 week
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tympanostomy Tube | Tube Retention | 21 ears |