Study of the Hummingbird TTS™ Tympanostomy Tube System

October 26, 2022 updated by: Preceptis Medical, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

109

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55409
        • Children's Hospitals and Clinics of Minnesota
      • Minneapolis, Minnesota, United States, 55409
        • University of Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
      • Saint Cloud, Minnesota, United States, 56303
        • St. Cloud Ear, Nose & Throat

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Children 6 months through 5 years of age, who are candidates for placement of VT.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Procedures Converted From Sedation to General Anesthesia
Time Frame: Intra-operative
Percentage of procedures that require conversion from sedation to general anesthesia
Intra-operative
Rate of Intra-operative Adverse Events
Time Frame: Intra-operative
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
Time Frame: Through discharge, estimated to be approximately 90 minutes post-procedure
Rate of adverse events that occur between the end of the procedure and discharge
Through discharge, estimated to be approximately 90 minutes post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Preceptis Medical, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 29, 2016

Primary Completion (Actual)

August 1, 2021

Study Completion (Actual)

August 1, 2021

Study Registration Dates

First Submitted

April 2, 2018

First Submitted That Met QC Criteria

April 18, 2018

First Posted (Actual)

April 20, 2018

Study Record Updates

Last Update Posted (Actual)

November 21, 2022

Last Update Submitted That Met QC Criteria

October 26, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Preceptis PMS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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