In-Office Study of the Hummingbird® in Children 6 Months-21 Years Old
NCT ID: NCT03544138
Last Updated: 2022-12-14
Study Results
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View full resultsBasic Information
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COMPLETED
NA
258 participants
INTERVENTIONAL
2018-07-24
2022-09-12
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Children 6 months to 21 years old
* Signed parental consent, and child assent documents as applicable.
* Parent is fluent in English.
Exclusion Criteria
* Anatomy precludes sufficient visualization and access to the tympanic membrane.
6 Months
21 Years
ALL
No
Sponsors
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Preceptis Medical, Inc.
INDUSTRY
Responsible Party
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Locations
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Cedars-Sinai Medical Care Foundation
Beverly Hills, California, United States
Children's Ear Nose Throat & Allergy
Orlando, Florida, United States
HealthPartners Institute
Bloomington, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
St. Cloud Ear, Nose & Throat
Saint Cloud, Minnesota, United States
Park Nicollet
Saint Louis Park, Minnesota, United States
Prairie Sinus Ear & Allergy, P.C.
Bismarck, North Dakota, United States
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Precepts Medical, Inc.
Other Identifiers
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Preceptis Pivotal
Identifier Type: -
Identifier Source: org_study_id