Study of the Hummingbird TTS™ Tympanostomy Tube System
- Conditions
- Otitis Media
- Registration Number
- NCT03503591
- Lead Sponsor
- Preceptis Medical, Inc.
- Brief Summary
The objective of this study was continued commercial evaluation of the intraoperative safety and performance of the H-TTS for the placement of ventilation tubes in pediatric patients undergoing a tympanostomy procedure under moderate sedation and local anesthetic.
- Detailed Description
The study was a multi-site, prospective and retrospective, treatment-only post-market study of the H-TTS. The study was performed in a commercial environment. Patients were already have a scheduled tympanostomy procedure with the H-TTS under moderate sedation and local anesthetic.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 109
- Age 6 months through 5 years of age
- Candidates for ventilation tube placement
- H-TTS used under moderate sedation and local anesthetic
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Rate of Adverse Events Through Discharge Through discharge, estimated to be approximately 90 minutes post-procedure Rate of adverse events that occur between the end of the procedure and discharge
Percentage of Procedures Converted From Sedation to General Anesthesia Intra-operative Percentage of procedures that require conversion from sedation to general anesthesia
Rate of Intra-operative Adverse Events Intra-operative Rate of intra-operative adverse events that occur from the beginning to the end of the procedure
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
Children's Hospitals and Clinics of Minnesota
🇺🇸Minneapolis, Minnesota, United States
St. Cloud Ear, Nose & Throat
🇺🇸Saint Cloud, Minnesota, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States