Study of the Hummingbird TTS™ Tympanostomy Tube System
Post-Market Surveillance Study of the Preceptis Medical, Inc. Hummingbird TTS™ Tympanostomy Tube System
1 other identifier
observational
109
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2016
Longer than P75 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 29, 2016
CompletedFirst Submitted
Initial submission to the registry
April 2, 2018
CompletedFirst Posted
Study publicly available on registry
April 20, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2021
CompletedResults Posted
Study results publicly available
November 21, 2022
CompletedNovember 21, 2022
October 1, 2022
5.5 years
April 2, 2018
September 26, 2022
October 26, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Percentage of Procedures Converted From Sedation to General Anesthesia
Percentage of procedures that require conversion from sedation to general anesthesia
Intra-operative
Rate of Intra-operative Adverse Events
Rate of intra-operative adverse events that occur from the beginning to the end of the procedure
Intra-operative
Rate of Adverse Events Through Discharge
Rate of adverse events that occur between the end of the procedure and discharge
Through discharge, estimated to be approximately 90 minutes post-procedure
Interventions
Insertion of a ventilation tube under sedation and local anesthetic
Eligibility Criteria
Children 6 months through 5 years of age, who are candidates for placement of VT.
You may qualify if:
- Age 6 months through 5 years of age
- Candidates for ventilation tube placement
- H-TTS used under moderate sedation and local anesthetic
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Children's Hospitals and Clinics of Minnesota
Minneapolis, Minnesota, 55409, United States
University of Minnesota
Minneapolis, Minnesota, 55409, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
St. Cloud Ear, Nose & Throat
Saint Cloud, Minnesota, 56303, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Steve Anderson, CEO
- Organization
- Preceptis Medical
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- OTHER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
- Post-Marketing Study
- Yes
Study Record Dates
First Submitted
April 2, 2018
First Posted
April 20, 2018
Study Start
January 29, 2016
Primary Completion
August 1, 2021
Study Completion
August 1, 2021
Last Updated
November 21, 2022
Results First Posted
November 21, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share