Skip to main content
OpenTrials
Completed

NCT Number: NCT03503591

Study of the 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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Otitis Media Ear Diseases Otitis Otorhinolaryngologic Diseases

Age range

6 month–5 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospitals and Clinics of Minnesota, Minneapolis, Minnesota, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 6 months through 5 years of age
  • Candidates for ventilation tube placement
  • H-TTS used under moderate sedation and local anesthetic

Treatment and study plan

Hummingbird Tympanostomy Tube System

Device

Insertion of a ventilation tube under sedation and local anesthetic

Primary outcomes

  1. Percentage of Procedures Converted From Sedation to General Anesthesia

    Time frame: Intra-operative

    Percentage of procedures that require conversion from sedation to general anesthesia

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Preceptis Medical, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2021
Study completion
2021
First posted
Apr 20, 2018
Registry last updated
Nov 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.