Acute Otitis Media, Otitis Media With Effusion
Conditions
Brief summary
The purpose of this study is to evaluate the performance and safety of the Tympanostomy Tube Delivery System (TTDS) for chronic otitis media or recurrent acute otitis media.
Interventions
DEVICEtympanostomy tube
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
Age
6 Months to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosed with either chronic otitis media with effusion or acute otitis media and scheduled to undergo tympanostomy tube insertion
Exclusion criteria
* Reaction to anesthesia * Markedly atrophic, 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 visualization and access to tympanic membrane * Anatomy that necessitates tympanostomy tube placement in posterior half of membrane
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of Tympanostomy Tube (TT) Delivery System | 7 days | Occurrence of pre-defined Safety Events of acoustic trauma, deployment of the TT into the middle ear, damage to middle ear structures, unintended tympanic membrane perforation requiring treatment, abrasion to the external acoustic meatus requiring significant treatment, and major bleeding requiring significant treatment. |
| Device Success | 0 days | Device Success is defined as the successful delivery of the tympanostomy tube across the tympanic membrane using the tympanostomy tube delivery system (TTDS).Device Success is evaluated on a per device basis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Subjects With Procedure Success | 0 days | Procedure Success was defined as the successful placement of any tympanostomy tube in all enrolled ears in a given subject. Non-Acclarent tubes successfully placed manually following non-success of the TTDS were counted toward Procedure Success. Procedure Success was determined on a per subject basis: the rate was calculated by the number of subjects achieving Procedure Success out of the total number of enrolled subjects. |
| Tube Retention | 7 days | Presence of the tympanostomy tube across the tympanic membrane at the follow-up visit. |
Countries
United States
Participant flow
Recruitment details
Eligible subjects presenting to the clinical study site for whom tympanostomy tube insertion was recommended were offered the opportunity to participate in the study by study investigators.
Participants by arm
| Arm | Count |
|---|---|
| Tympanostomy Tube Placement Using the Tube Delivery System | 53 |
| Total | 53 |
Baseline characteristics
| Characteristic | Tympanostomy Tube Placement Using the Tube Delivery System |
|---|---|
| Age, Continuous | 2.68 years STANDARD_DEVIATION 2.49 |
| Age, Customized <=5 years | 47 participants |
| Age, Customized >5 years | 6 participants |
| Region of Enrollment United States | 53 participants |
| Sex: Female, Male Female | 22 Participants |
| Sex: Female, Male Male | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 4 / 53 |
| serious Total, serious adverse events | 0 / 53 |
Outcome results
Primary
Device Success
Device Success is defined as the successful delivery of the tympanostomy tube across the tympanic membrane using the tympanostomy tube delivery system (TTDS).Device Success is evaluated on a per device basis.
Time frame: 0 days
Population: Device Success is evaluated on a per device basis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tympanostomy Tube Placement Using the Tube Delivery System | Device Success | 94.1 percentage of devices |
Primary
Safety of Tympanostomy Tube (TT) Delivery System
Occurrence of pre-defined Safety Events of acoustic trauma, deployment of the TT into the middle ear, damage to middle ear structures, unintended tympanic membrane perforation requiring treatment, abrasion to the external acoustic meatus requiring significant treatment, and major bleeding requiring significant treatment.
Time frame: 7 days
Population: Subjects in whom TTDS was attempted.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tympanostomy Tube Placement Using the Tube Delivery System | Safety of Tympanostomy Tube (TT) Delivery System | 0.0 percentage of ears |
Secondary
Proportion of Subjects With Procedure Success
Procedure Success was defined as the successful placement of any tympanostomy tube in all enrolled ears in a given subject. Non-Acclarent tubes successfully placed manually following non-success of the TTDS were counted toward Procedure Success. Procedure Success was determined on a per subject basis: the rate was calculated by the number of subjects achieving Procedure Success out of the total number of enrolled subjects.
Time frame: 0 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tympanostomy Tube Placement Using the Tube Delivery System | Proportion of Subjects With Procedure Success | 100 percentage of participants |
Secondary
Tube Retention
Presence of the tympanostomy tube across the tympanic membrane at the follow-up visit.
Time frame: 7 days
Population: Tube retention was assessed for all TT successfully placed by the TTDS
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tympanostomy Tube Placement Using the Tube Delivery System | Tube Retention | 99.0 percentage of tubes retained |