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Pivotal Clinic Study of the H-TTS

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ClinicalTrials.gov Identifier: NCT03544138
Recruitment Status : Recruiting
First Posted : June 1, 2018
Last Update Posted : March 20, 2019
Sponsor:
Information provided by (Responsible Party):
Preceptis Medical, Inc.

Brief Summary:
The objective of this study is to evaluate the safety and performance of the H-TTS for the placement of ear tubes in patients undergoing tympanostomy tube placement in an otolaryngology clinic using local anesthetic.

Condition or disease Intervention/treatment Phase
Ear Infection Otitis Media Device: Hummingbird Tympanostomy Tube System (H-TTS) Not Applicable

Detailed Description:

The H-TTS is indicated for patients undergoing a tympanostomy tube procedure. The H-TTS is intended to deliver a tympanostomy tube through the tympanic membrane of a patient during a tympanostomy procedure.

The Hummingbird Tympanostomy Tube System (H-TTS) is a disposable surgical tool designed to deliver a tympanostomy tube ("ear tube") into the tympanic membrane of patients during a tympanostomy tube placement procedure. More than 1,000,000 ear tubes are inserted annually in the US, making it one of the most common surgical procedures performed in children. Most ear tubes are inserted by otolaryngologists using either local anesthesia (usually adults) or general anesthesia (usually children).

Preceptis Medical, Inc. has developed the H-TTS to reduce trauma, pain, and risk to the patient while reducing the overall surgical procedure time. The H-TTS integrates the multiple surgical instruments necessary for current surgical procedure into a single, one-pass device. The H-TTS creates an incision in the tympanic membrane ("ear drum") and inserts a tympanostomy tube with the push of a lever. Thus, the H-TTS allows placement of a tympanostomy tube with a single pass down the ear canal. The ear tube used with the H-TTS is a standard, commercially available tympanostomy tube. The H-TTS has been cleared by the FDA for use in a hospital or ASC setting under both general anesthesia and moderate (conscious) sedation.

The study will be a multi-site, prospective, treatment-only study of the H-TTS. Enrollment in the study at each site will begin after receipt of Institutional Review Board (IRB) approval. 50 to 200 patients will be included at 3-10 clinical sites.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pivotal Study of the Preceptis Medical Inc. Hummingbird™ Tympanostomy Tube System (H-TTS) in the Otolaryngology Clinic: A Non-Significant Risk Study
Actual Study Start Date : July 24, 2018
Estimated Primary Completion Date : August 31, 2019
Estimated Study Completion Date : December 31, 2019

Arm Intervention/treatment
Hummingbird Tympanostomy Tube System (H-TTS)
The Hummingbird Tympanostomy Tube System (H-TTS) is a disposable surgical tool designed to deliver a tympanostomy tube ("ear tube") into the tympanic membrane of patients during a tympanostomy tube placement procedure.
Device: Hummingbird Tympanostomy Tube System (H-TTS)
The H-TTS is intended to deliver a tympanostomy tube through the tympanic membrane of a patient during a tympanostomy procedure.
Other Name: H-TTS




Primary Outcome Measures :
  1. The rate of procedural AEs, and the rates for each specific type of event [ Time Frame: Intra-Procedure ]
    The rate of procedural AEs, and the rates for each specific type of event, will be estimated.

  2. Successful delivery of the tympanostomy tube by the H-TTS [ Time Frame: Intra-Procedure ]
    Efficacy evaluation will consist of determining whether the H-TTS device successfully delivers the tympanostomy tube across the tympanic membrane.



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Ages Eligible for Study:   6 Months to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Scheduled to undergo tympanostomy tube insertion in the clinic.
  • Ages ≥6 months through ≤24 months or ≥5 years through ≤12 years.
  • Signed parental consent, and child assent documents as applicable.
  • Parent is fluent in English.

Exclusion Criteria:

  • Any condition that, in the opinion of the investigator, may place the subject at greater risk (e.g., child with developmental delay).
  • Anatomy precludes sufficient visualization and access to the tympanic membrane.

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): NCT03544138


Contacts
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Contact: Nicole LaSota, BA 612-900-5441 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: Gene Liu, MD    310-423-1220    LiuGC@csmns.org   
Principal Investigator: Gene Liu, MD         
Sub-Investigator: Frank Rimell, MD         
United States, Florida
Pediatric Otolaryngology Associates, LLC Not yet recruiting
Jacksonville, Florida, United States, 32257
Contact: Daniel Wohl, MD    904-262-7368    dwohl@ent4kids.net   
Principal Investigator: Daniel Wohl, MD         
Children's Ear Nose Throat & Allergy Recruiting
Orlando, Florida, United States, 32835
Contact: Isabel Opio    407-253-1000 ext 107    iiopio@childrenentdocs.com   
Principal Investigator: James Kosko, MD         
Sub-Investigator: Cheryl Cotter, MD         
Sub-Investigator: Eric Jaryszak, MD         
Sub-Investigator: Joshua Gottschall         
United States, Minnesota
HealthPartners Institute Recruiting
Bloomington, Minnesota, United States, 55425-4516
Contact: Kyra Wicklund    651-254-5303    Kyra.E.Wicklund@HealthPartners.Com   
Contact: Jenny Koops    651-254-5316    Jenny.J.Koops@HealthPartners.Com   
Principal Investigator: Chris Hilton, MD         
Sub-Investigator: Derek Schmidt, MD         
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Nicole Tombers, RN    507-538-1392 ext 2    tombers.nicole@mayo.edu   
Principal Investigator: Shelagh Cofer, MD         
St. Cloud Ear, Nose & Throat Recruiting
Saint Cloud, Minnesota, United States, 56303
Contact: Jen Wipper    320-204-5887    wipperj@pinnacleresearch.org   
Contact: Alisse Amundson    320-204-5887    amundsona@pinnacleresearch.org   
Principal Investigator: Theodore Truitt, MD         
Park Nicollet Recruiting
Saint Louis Park, Minnesota, United States, 55416
Contact: Kyra Wicklund    651-254-5303    Kyra.E.Wicklund@HealthPartners.com   
Contact: Jenny Koops    651-254-5316    Jenny.J.Koops@HealthPartners.com   
Principal Investigator: Sandra Skovlund, MD         
Sub-Investigator: Grace Nimmons, MD         
United States, North Dakota
Prairie Sinus Ear & Allergy, P.C. Recruiting
Bismarck, North Dakota, United States, 58503-0697
Contact: Jay Raisen, MD    701-805-8057    jay.raisen@prairieseaclinic.com   
Principal Investigator: Jay Raisen, MD         
Altru Professional Center Recruiting
Grand Forks, North Dakota, United States, 58201
Contact: Brenda Westacott    701-780-1845    bwestacott@altru.org   
Principal Investigator: Alan Johnson, MD         
Sponsors and Collaborators
Preceptis Medical, Inc.

Additional Information:
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Responsible Party: Preceptis Medical, Inc.
ClinicalTrials.gov Identifier: NCT03544138     History of Changes
Other Study ID Numbers: Preceptis Pivotal
First Posted: June 1, 2018    Key Record Dates
Last Update Posted: March 20, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to make IPD available to other researchers.

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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: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Otitis
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases