Otitis Media
Conditions
Keywords
tympanostomy, myringotomy, otitis media, ear tubes, ear infection
Brief summary
The purpose of this study is to determine if the Hummingbird ear tube delivery system is a safe and effective way to put ear tubes in place.
Detailed description
The objective of this study is to evaluate the safety and performance of the TTI device for the placement of ear tubes in patients undergoing a tympanostomy tube placement procedure.The trial will be a multi-site, prospective, treatment only study of the Preceptis ear tube introducer . Patients will already have a scheduled tympanostomy procedure. Enrollment in the study at each site will begin after receipt of Institutional Review Board (IRB) approval. Patients will be considered enrolled at the time the informed consent document is signed. A maximum of two hundred fifty (250) subjects will be included in the study at up to 5 sites.
Interventions
DEVICEEar tube placement with the Hummingbird TTS
Using the Hummingbird TTS to make a myringotomy and deliver a tympanostomy tube across the tympanic membrane with one pass.
Sponsors
Preceptis Medical, Inc.
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
1. Scheduled to undergo tympanostomy tube insertion. 2. At least 6 months old. 3. Subject is able and willing to comply with follow-up requirements. 4. Signed Informed Consent, Parental Consent Form, or Child Assent Form as applicable.
Exclusion criteria
1. Any condition that in the opinion of the investigator may place the subject at greater risk (e.g., pregnancy) 2. Significantly atrophic tympanic membrane. 3. Significantly atelectatic tympanic membrane. For example, the tympanic membrane is in contact with the promontory of the cochlea. 4. Anatomy precludes sufficient visualization and access to the tympanic membrane.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Ears in Which an Ear Tube Was Successfully Delivered Across the Tympanic Membrane | intra operative | Success will be determined at the end of each ear tube procedure, by whether or not the TTS was used during the tympanostomy procedure to make an incision in the tympanic membrane and deploy an ear tube. Data may be presented when enrollment has been completed and all pre-operative and procedure data are analyzed. |
| Number of Participants With Intra-operative Adverse Events | Intra-operative | Any intra-operative adverse events, anticipated or unanticipated |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Hummingbird TTS Treatment only surgical instrument study | 199 |
| Total | 199 |
Baseline characteristics
| Characteristic | Hummingbird TTS |
|---|---|
| Age, Customized | 20 months |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 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 | 199 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment United States | 199 participants |
| Sex: Female, Male Female | NA Participants |
| Sex: Female, Male Male | NA Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 199 |
| other Total, other adverse events | 0 / 199 |
| serious Total, serious adverse events | 0 / 199 |
Outcome results
Primary
Number of Participants With Intra-operative Adverse Events
Any intra-operative adverse events, anticipated or unanticipated
Time frame: Intra-operative
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Hummingbird TTS | Number of Participants With Intra-operative Adverse Events | 0 Participants |
Primary
Percentage of Ears in Which an Ear Tube Was Successfully Delivered Across the Tympanic Membrane
Success will be determined at the end of each ear tube procedure, by whether or not the TTS was used during the tympanostomy procedure to make an incision in the tympanic membrane and deploy an ear tube. Data may be presented when enrollment has been completed and all pre-operative and procedure data are analyzed.
Time frame: intra operative
Population: 393 ears in 199 patients received ear tube placement from the Hummingbird device.
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Hummingbird TTS | Percentage of Ears in Which an Ear Tube Was Successfully Delivered Across the Tympanic Membrane | 393 Ears |