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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hummingbird Tympanostomy Tube System (H-TTS) | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hummingbird Tympanostomy Tube System (H-TTS) | Device | The H-TTS is intended to deliver a tympanostomy tube through the tympanic membrane of a patient during a tympanostomy procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Follow-up between 3-10 weeks |
| 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. | Intra-Procedure |
| 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. | Intra-procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Care Foundation | Beverly Hills | California | 90211 | United States | ||
| Children's Ear Nose Throat & Allergy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33869765 | Derived | Truitt TO, Kosko JR, Nimmons GL, Raisen J, Skovlund SM, Rimell F, Cofer SA. In-office insertion tympanostomy tubes in children using single-pass device. Laryngoscope Investig Otolaryngol. 2021 Feb 2;6(2):325-331. doi: 10.1002/lio2.533. eCollection 2021 Apr. |
| Label | URL |
|---|---|
| Precepts Medical, Inc. | View source |
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There is no plan to make IPD available to other researchers.
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| ID | Title | Description |
|---|---|---|
| FG000 | Hummingbird Tympanostomy Tube System (H-TTS) Tube Delivery | Subjects will have ear tubes placed with the Hummingbird Tympanostomy Tube System (H-TTS) in an office setting using topical anesthetic. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Rate of ears experiencing an adverse event. There were 258 participants and 492 ears analyzed. | Posted | Number | percentage of ears | Follow-up between 3-10 weeks | Ears | Ears |
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All adverse events (AE), both anticipated and unanticipated, were reported through follow-up of 3-10 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute tube extrusion | Surgical and medical procedures | Systematic Assessment | During the surgical procedure, a myringotomy incision is completed but the tympanostomy tube will not stay in the tympanic membrane. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Steve Anderson | Preceptis Medical | 612-327-4795 | steve@preceptismedical.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 29, 2020 | Sep 12, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010031 | Otitis |
| D010033 | Otitis Media |
| ID | Term |
|---|---|
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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|
| Orlando |
| Florida |
| 32835 |
| United States |
| HealthPartners Institute | Bloomington | Minnesota | 55425-4516 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| St. Cloud Ear, Nose & Throat | Saint Cloud | Minnesota | 56303 | United States |
| Park Nicollet | Saint Louis Park | Minnesota | 55416 | United States |
| Prairie Sinus Ear & Allergy, P.C. | Bismarck | North Dakota | 58503-0697 | United States |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
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| Ears |
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| 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. | Posted | Number | percentage of ears | Intra-Procedure | Ears | Ears |
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| 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. | Posted | Number | percentage of participants | Intra-procedure |
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| 0 |
| 258 |
| 0 |
| 258 |
| 1 |
| 258 |
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| Tube dislocating into middle ear space | Surgical and medical procedures | Systematic Assessment | Tube passes completely through the tympanic membrane and falls into the middle ear cavity and is unable to be retrieved in office |
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