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Study of the Hummingbird TTS™ Tympanostomy Tube System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03503591
Recruitment Status : Recruiting
First Posted : April 20, 2018
Last Update Posted : October 18, 2018
Sponsor:
Information provided by (Responsible Party):
Preceptis Medical, Inc.

Brief Summary:
The objective of this study is 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.

Condition or disease Intervention/treatment
Otitis Media Device: Hummingbird Tympanostomy Tube System

Detailed Description:
The study will be a multi-site, prospective, treatment-only post-market study of the H-TTS. The study will be performed in a commercial environment. Patients will already have a scheduled tympanostomy procedure with the H-TTS under moderate sedation and local anesthetic. A minimum of one hundred-sixty-seven (167) subjects will be included in the study at 5 sites.

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Study Type : Observational
Estimated Enrollment : 167 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Post-Market Surveillance Study of the Preceptis Medical, Inc. Hummingbird TTS™ Tympanostomy Tube System
Actual Study Start Date : January 29, 2016
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ear Infections


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


Primary Outcome Measures :
  1. Rate of conversion [ Time Frame: Intra-operative ]
    Rate of conversion from sedation to general anesthesia

  2. Adverse Events [ Time Frame: Intra-operative ]
    Rate of intra-operative adverse events

  3. Adverse Events [ Time Frame: Through discharge, estimated to be approximately 90 minutes post-procedure ]
    Rate of adverse events through discharge



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Children 6 months through 5 years of age, who are candidates for placement of VT.
Criteria

Inclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03503591


Contacts
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Contact: Sarah Hase, BA 763-710-4518 clinical@preceptismedical.com
Contact: Steve Anderson 763-568-7809 steve@preceptismedical.com

Locations
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United States, California
Cedars-Sinai Medical Care Foundation Not yet recruiting
Beverly Hills, California, United States, 90211
Contact: Sarah Gunther    310-385-2974    Sarah.Gunther@cshs.org   
Principal Investigator: Gene Liu, MD         
United States, Delaware
The Nemours Foundation Withdrawn
Wilmington, Delaware, United States, 19803
United States, Minnesota
Mayo Clinic Completed
Rochester, Minnesota, United States, 55905
St. Cloud Ear, Nose & Throat Recruiting
Saint Cloud, Minnesota, United States, 56303
Contact: Jen Wipper    320-204-5887    wipperj@pinnacleresearch.org   
Principal Investigator: Theodore Truitt, MD         
Sponsors and Collaborators
Preceptis Medical, Inc.

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Responsible Party: Preceptis Medical, Inc.
ClinicalTrials.gov Identifier: NCT03503591     History of Changes
Other Study ID Numbers: Preceptis PMS
First Posted: April 20, 2018    Key Record Dates
Last Update Posted: October 18, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Preceptis Medical, Inc.:
tympanostomy
myringotomy
otitis media
ear tubes
ear infection
Additional relevant MeSH terms:
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Otitis
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases