Study of the Hummingbird TTS™ Tympanostomy Tube System

Overview

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.

Full Title of Study: “Post-Market Surveillance Study of the Preceptis Medical, Inc. Hummingbird TTS™ Tympanostomy Tube System”

Study Type

• Study Type: Observational
• Study Design
  • Time Perspective: Other
• Study Primary Completion Date: August 2021

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.

Interventions

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

Clinical Trial Outcome Measures

Primary Measures

• Percentage of Procedures Converted From Sedation to General Anesthesia
  • Time Frame: Intra-operative
  • Percentage of procedures that require conversion from sedation to general anesthesia
• 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
• 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

Participating in This Clinical Trial

Inclusion Criteria

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

Gender Eligibility: All

Minimum Age: 6 Months

Maximum Age: 5 Years

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Preceptis Medical, Inc.
• Provider of Information About this Clinical Study
  • Sponsor