MedTrace Logo

Study of the Hummingbird TTS™ Tympanostomy Tube System

NCT03503591 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 109

Last updated 2022-11-21

Study results available
· View outcomes & findings →

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.

Conditions

  • Otitis Media

Interventions

DEVICE

Hummingbird Tympanostomy Tube System

Insertion of a ventilation tube under sedation and local anesthetic

Sponsors & Collaborators

  • Preceptis Medical, Inc.

    lead INDUSTRY

Eligibility

Min Age
6 Months
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-29
Primary Completion
2021-08-31
Completion
2021-08-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03503591 on ClinicalTrials.gov