Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
199 participants
INTERVENTIONAL
2014-01-31
2018-03-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Hummingbird TTS
Ear tube placement with the Hummingbird TTS
Ear 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.
Interventions
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Ear 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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
6 Months
ALL
No
Sponsors
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Preceptis Medical, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Frank Rimell, MD
Role: PRINCIPAL_INVESTIGATOR
Children's Hospitals and Clinics of Minnesota
Locations
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Fairview Maple Grove Surgery Center
Maple Grove, Minnesota, United States
Children's Hospitals and Clinics of Minnesota
Minneapolis, Minnesota, United States
University of Minnesota Masonic Children's Hospital
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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Preceptis Alpha
Identifier Type: -
Identifier Source: org_study_id
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