Study of the Hummingbird TTS™ Tympanostomy Tube System

Otitis Media Clinical Trial

Official title:

Post-Market Surveillance Study of the Preceptis Medical, Inc. Hummingbird TTS™ Tympanostomy Tube System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03503591
• Other study ID #: Preceptis PMS
• Status: Completed
• Start date: January 29, 2016
• Est. completion date: August 2021

Study information

• Verified date: October 2022
• Source: Preceptis Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: August 2021
• Est. primary completion date: August 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 5 Years

Eligibility

Inclusion Criteria:

• Age 6 months through 5 years of age

• Candidates for ventilation tube placement

• H-TTS used under moderate sedation and local anesthetic

Related Conditions & MeSH terms

• Otitis
• Otitis Media

Intervention

Device:
• Hummingbird Tympanostomy Tube System
Insertion of a ventilation tube under sedation and local anesthetic

Locations

Country	Name	City	State
United States	Children's Hospitals and Clinics of Minnesota	Minneapolis	Minnesota
United States	University of Minnesota	Minneapolis	Minnesota
United States	Mayo Clinic	Rochester	Minnesota
United States	St. Cloud Ear, Nose & Throat	Saint Cloud	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Preceptis Medical, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Procedures Converted From Sedation to General Anesthesia	Percentage of procedures that require conversion from sedation to general anesthesia	Intra-operative
Primary	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
Primary	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