Otitis Media Clinical Trial
Official title:
Pivotal Study of the Preceptis Medical Inc. Hummingbird™ Tympanostomy Tube System (H-TTS) in the Otolaryngology Clinic
Verified date | November 2022 |
Source | Preceptis Medical, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 258 |
Est. completion date | September 12, 2022 |
Est. primary completion date | September 6, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Months to 21 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Cedars-Sinai Medical Care Foundation | Beverly Hills | California |
United States | Prairie Sinus Ear & Allergy, P.C. | Bismarck | North Dakota |
United States | HealthPartners Institute | Bloomington | Minnesota |
United States | Children's Ear Nose Throat & Allergy | Orlando | Florida |
United States | Mayo Clinic | Rochester | Minnesota |
United States | St. Cloud Ear, Nose & Throat | Saint Cloud | Minnesota |
United States | Park Nicollet | Saint Louis Park | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Preceptis Medical, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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. | Follow-up between 3-10 weeks | |
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. | Intra-Procedure | |
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. | Intra-procedure |
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