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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03503591
Other study ID # Preceptis PMS
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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