Ear Infection, Otitis Media
Conditions
Brief summary
The objective of this study is to evaluate the safety and performance of the Hummingbird® for the placement of ear tubes in children undergoing tympanostomy tube placement in an otolaryngology clinic using local anesthetic.
Detailed description
The Hummingbird Tympanostomy Tube System (H-TTS) is intended to deliver a tympanostomy tube (also referred to as a ventilation tube) through the tympanic membrane of the patient and is indicated to be used in office settings for children. The H-TTS is intended to deliver a tympanostomy tube through the tympanic membrane (TM) of the patient. It combines the separate functions of creating a myringotomy, and positioning and placing a ventilation tube across the TM. The Hummingbird Tympanostomy Tube System (H-TTS) is a disposable surgical tool designed to deliver a tympanostomy tube (ear tube) into the tympanic membrane of patients during a tympanostomy tube placement procedure. More than 1,000,000 ear tubes are inserted annually in the US, making it one of the most common surgical procedures performed in children. Preceptis Medical, Inc. has developed the H-TTS to reduce trauma, pain, and risk to the patient while reducing the overall surgical procedure time. The H-TTS integrates the multiple surgical instruments necessary for current surgical procedure into a single, one-pass device. The H-TTS creates an incision in the tympanic membrane (ear drum) and inserts a tympanostomy tube with the push of a lever. Thus, the H-TTS allows placement of a tympanostomy tube with a single pass down the ear canal. The ear tube used with the H-TTS is a standard, commercially available tympanostomy tube.
Interventions
DEVICEHummingbird Tympanostomy Tube System (H-TTS)
The H-TTS is intended to deliver a tympanostomy tube through the tympanic membrane of a patient during a tympanostomy procedure.
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 21 Years
Healthy volunteers
No
Inclusion criteria
* Scheduled to undergo tympanostomy tube insertion in the clinic. * Children 6 months to 21 years old * Signed parental consent, and child assent documents as applicable. * Parent is fluent in English.
Exclusion criteria
* Any condition that, in the opinion of the investigator, may place the subject at greater risk (e.g., child with developmental delay). * Anatomy precludes sufficient visualization and access to the tympanic membrane.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Ears Experiencing an Adverse Events From Enrollment to 3-10 Week Follow-up | Follow-up between 3-10 weeks | AEs that occurred from enrollment through the 3-10 week follow-up were collected. |
| Percentage of Ears With Successful Delivery of the Tympanostomy Tube by the H-TTS | Intra-Procedure | Efficacy evaluation will consist of determining whether the H-TTS device successfully delivers the tympanostomy tube across the tympanic membrane. |
| Percentage of Participants With Successful Completion of Procedure In-office | Intra-procedure | Success will be defined as the ability of the surgeon to place ear tubes using the H-TTS device in the office setting with the use of local anesthetic. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Hummingbird Tympanostomy Tube System (H-TTS) The Hummingbird Tympanostomy Tube System (H-TTS) is a disposable surgical tool designed to deliver a tympanostomy tube (ear tube) into the tympanic membrane of patients during a tympanostomy tube placement procedure.
Hummingbird Tympanostomy Tube System (H-TTS): The H-TTS is intended to deliver a tympanostomy tube through the tympanic membrane of a patient during a tympanostomy procedure. | 258 |
| Total | 258 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 29 |
Baseline characteristics
| Characteristic | Hummingbird Tympanostomy Tube System (H-TTS) | — |
|---|---|---|
| Age, Categorical <=18 years | 258 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 0 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 258 participants | — |
| Sex: Female, Male Female | 110 Participants | — |
| Sex: Female, Male Male | 148 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 258 |
| other Total, other adverse events | 1 / 258 |
| serious Total, serious adverse events | 0 / 258 |
Outcome results
Primary
Percentage of Ears With Successful Delivery of the Tympanostomy Tube by the H-TTS
Efficacy evaluation will consist of determining whether the H-TTS device successfully delivers the tympanostomy tube across the tympanic membrane.
Time frame: Intra-Procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hummingbird Tympanostomy Tube System (H-TTS) | Percentage of Ears With Successful Delivery of the Tympanostomy Tube by the H-TTS | 97.2 percentage of ears |
Primary
Percentage of Participants With Successful Completion of Procedure In-office
Success will be defined as the ability of the surgeon to place ear tubes using the H-TTS device in the office setting with the use of local anesthetic.
Time frame: Intra-procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hummingbird Tympanostomy Tube System (H-TTS) | Percentage of Participants With Successful Completion of Procedure In-office | 98.4 percentage of participants |
Primary
Rate of Ears Experiencing an Adverse Events From Enrollment to 3-10 Week Follow-up
AEs that occurred from enrollment through the 3-10 week follow-up were collected.
Time frame: Follow-up between 3-10 weeks
Population: Rate of ears experiencing an adverse event. There were 258 participants and 492 ears analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Hummingbird Tympanostomy Tube System (H-TTS) | Rate of Ears Experiencing an Adverse Events From Enrollment to 3-10 Week Follow-up | 0.41 percentage of ears |