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Hummingbird TTS Ear Tube Delivery Study

Primary Purpose

Otitis Media

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ear tube placement with the Hummingbird TTS
Sponsored by
Preceptis Medical, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Otitis Media focused on measuring tympanostomy, myringotomy, otitis media, ear tubes, ear infection

Eligibility Criteria

6 Months - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Fairview Maple Grove Surgery Center
  • Children's Hospitals and Clinics of Minnesota
  • University of Minnesota Masonic Children's Hospital
  • Mayo Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hummingbird TTS

Arm Description

Ear tube placement with the Hummingbird TTS

Outcomes

Primary Outcome Measures

Percentage of Ears in Which an Ear Tube Was Successfully Delivered Across the Tympanic Membrane
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.
Number of Participants With Intra-operative Adverse Events
Any intra-operative adverse events, anticipated or unanticipated

Secondary Outcome Measures

Full Information

First Posted
June 12, 2014
Last Updated
December 11, 2018
Sponsor
Preceptis Medical, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02165384
Brief Title
Hummingbird TTS Ear Tube Delivery Study
Official Title
Continued Evaluation of the Preceptis Medical, Inc. Tympanostomy Ear Tube Introducer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
January 2014 (Actual)
Primary Completion Date
March 1, 2018 (Actual)
Study Completion Date
March 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Preceptis Medical, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Otitis Media
Keywords
tympanostomy, myringotomy, otitis media, ear tubes, ear infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
199 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hummingbird TTS
Arm Type
Experimental
Arm Description
Ear tube placement with the Hummingbird TTS
Intervention Type
Device
Intervention Name(s)
Ear tube placement with the Hummingbird TTS
Other Intervention Name(s)
Preceptis Medical, Inc. Tympanostomy Tube Introducer System, Hummingbird Tympanostomy Tube Delivery System, Hummingbird TTS
Intervention Description
Using the Hummingbird TTS to make a myringotomy and deliver a tympanostomy tube across the tympanic membrane with one pass.
Primary Outcome Measure Information:
Title
Percentage of Ears in Which an Ear Tube Was Successfully Delivered Across the Tympanic Membrane
Description
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.
Time Frame
intra operative
Title
Number of Participants With Intra-operative Adverse Events
Description
Any intra-operative adverse events, anticipated or unanticipated
Time Frame
Intra-operative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Scheduled to undergo tympanostomy tube insertion. At least 6 months old. Subject is able and willing to comply with follow-up requirements. Signed Informed Consent, Parental Consent Form, or Child Assent Form as applicable. Exclusion Criteria: Any condition that in the opinion of the investigator may place the subject at greater risk (e.g., pregnancy) Significantly atrophic tympanic membrane. Significantly atelectatic tympanic membrane. For example, the tympanic membrane is in contact with the promontory of the cochlea. Anatomy precludes sufficient visualization and access to the tympanic membrane.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank Rimell, MD
Organizational Affiliation
Children's Hospitals and Clinics of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fairview Maple Grove Surgery Center
City
Maple Grove
State/Province
Minnesota
ZIP/Postal Code
55369
Country
United States
Facility Name
Children's Hospitals and Clinics of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
University of Minnesota Masonic Children's Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55454
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

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Hummingbird TTS Ear Tube Delivery Study

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