Hummingbird TTS Ear Tube Delivery Study

December 11, 2018 updated by: Preceptis Medical, Inc.

Continued Evaluation of the Preceptis Medical, Inc. Tympanostomy Ear Tube Introducer

The purpose of this study is to determine if the Hummingbird ear tube delivery system is a safe and effective way to put ear tubes in place.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The objective of this study is to evaluate the safety and performance of the TTI device for the placement of ear tubes in patients undergoing a tympanostomy tube placement procedure.The trial will be a multi-site, prospective, treatment only study of the Preceptis ear tube introducer . Patients will already have a scheduled tympanostomy procedure. Enrollment in the study at each site will begin after receipt of Institutional Review Board (IRB) approval. Patients will be considered enrolled at the time the informed consent document is signed. A maximum of two hundred fifty (250) subjects will be included in the study at up to 5 sites.

Study Type

Interventional

Enrollment (Actual)

199

Phase

  • Not Applicable

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
      • Maple Grove, Minnesota, United States, 55369
        • Fairview Maple Grove Surgery Center
      • Minneapolis, Minnesota, United States, 55404
        • Children's Hospitals and Clinics of Minnesota
      • Minneapolis, Minnesota, United States, 55454
        • University of Minnesota Masonic Children's Hospital
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic

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 and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Scheduled to undergo tympanostomy tube insertion.
  2. At least 6 months old.
  3. Subject is able and willing to comply with follow-up requirements.
  4. Signed Informed Consent, Parental Consent Form, or Child Assent Form as applicable.

Exclusion Criteria:

  1. Any condition that in the opinion of the investigator may place the subject at greater risk (e.g., pregnancy)
  2. Significantly atrophic tympanic membrane.
  3. Significantly atelectatic tympanic membrane. For example, the tympanic membrane is in contact with the promontory of the cochlea.
  4. Anatomy precludes sufficient visualization and access to the tympanic membrane.

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hummingbird TTS
Ear tube placement with the Hummingbird TTS
Device: Ear tube placement with the Hummingbird TTS
Using the Hummingbird TTS to make a myringotomy and deliver a tympanostomy tube across the tympanic membrane with one pass.
Other Names:
  • Preceptis Medical, Inc. Tympanostomy Tube Introducer System
  • Hummingbird Tympanostomy Tube Delivery System
  • Hummingbird TTS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Ears in Which an Ear Tube Was Successfully Delivered Across the Tympanic Membrane
Time Frame: intra operative
Success will be determined at the end of each ear tube procedure, by whether or not the TTS was used during the tympanostomy procedure to make an incision in the tympanic membrane and deploy an ear tube. Data may be presented when enrollment has been completed and all pre-operative and procedure data are analyzed.
intra operative
Number of Participants With Intra-operative Adverse Events
Time Frame: Intra-operative
Any intra-operative adverse events, anticipated or unanticipated
Intra-operative

Collaborators and Investigators

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

Sponsor

Preceptis Medical, Inc.

Investigators

  • Principal Investigator: Frank Rimell, MD, Children's Hospitals and Clinics of Minnesota

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 1, 2014

Primary Completion (Actual)

March 1, 2018

Study Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

June 12, 2014

First Submitted That Met QC Criteria

June 16, 2014

First Posted (Estimate)

June 17, 2014

Study Record Updates

Last Update Posted (Actual)

January 3, 2019

Last Update Submitted That Met QC Criteria

December 11, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Preceptis Alpha

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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