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Clinical Evaluation of the TOMi Scope

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ClinicalTrials.gov Identifier: NCT03890107
Recruitment Status : Recruiting
First Posted : March 26, 2019
Last Update Posted : April 17, 2019
Sponsor:
Collaborators:
Carle Foundation Hospital
Children's National Health System
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
PhotoniCare, Inc.

Study Description
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Brief Summary:
The objective of this study is to evaluate the imaging capabilities and image analysis performance of the PhotoniCare TOMi Scope in pediatric patients undergoing tympanostomy tube placement for otitis media. In this observational study, results of TOMi Scope imaging will not affect patient standard of care.

Condition or disease Intervention/treatment
Otitis Media Device: PhotoniCare TOMi Scope

Study Design
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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Evaluation of a New Middle Ear Diagnostic to Support FDA Regulatory Clearance
Actual Study Start Date : April 15, 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ear Infections

Groups and Cohorts
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Group/Cohort Intervention/treatment
Pediatric tympanostomy tube patients
Patients diagnosed with otitis media and scheduled for tympanostomy tube placement will be imaged with the PhotoniCare TOMi Scope
 Device: PhotoniCare TOMi Scope
PhotoniCare TOMi Scope imaging using a near-infrared laser


Outcome Measures
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Primary Outcome Measures :
  1. PhotoniCare TOMi Scope imaging exam [ Time Frame: 1-5 minutes ]
    Optical coherence tomography imaging to evaluate the middle ear.


Secondary Outcome Measures :
  1. Adverse events [ Time Frame: Date of recruitment (day of surgery) to post-operative follow-up visit (approx. 1 month, but can be longer) ]
    Rate of adverse events


Biospecimen Retention:   Samples With DNA
Middle ear effusion, if present

Eligibility Criteria
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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Children diagnosed with otitis media and scheduled for tympanostomy tube surgery.
Criteria

Inclusion Criteria:

  • Children (17 years old or younger) scheduled for tympanostomy tube placement

Exclusion Criteria:

  • Otoscopy contra-indicated or not possible per attending physician's decision
Contacts and Locations
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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): NCT03890107


Contacts
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Contact: Ryan Nolan, M.Eng., CCRP 866-411-3277 ext 1 rnolan@photoni.care

Locations
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United States, District of Columbia
Children's National Health System Recruiting
Washington, District of Columbia, United States, 20010
Contact: Diego Preciado, MD, PhD         
Principal Investigator: Nancy Bauman, MD         
Principal Investigator: Diego Preciado, MD, PhD         
United States, Illinois
Carle Foundation Hospital Not yet recruiting
Urbana, Illinois, United States, 61801
Sub-Investigator: Michael Novak, MD         
Principal Investigator: Ryan Porter, MD         
Sponsors and Collaborators
PhotoniCare, Inc.
Carle Foundation Hospital
Children's National Health System
National Institute on Deafness and Other Communication Disorders (NIDCD)
Investigators
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Principal Investigator: Ryan Shelton, PhD PhotoniCare, Inc.
More Information
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Responsible Party: PhotoniCare, Inc.
ClinicalTrials.gov Identifier: NCT03890107     History of Changes
Other Study ID Numbers: 000001
R44DC014599 ( U.S. NIH Grant/Contract )
First Posted: March 26, 2019    Key Record Dates
Last Update Posted: April 17, 2019
Last Verified: April 2019
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: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by PhotoniCare, Inc.:
Ear Infection
Ear tubes
Myringotomy
Otitis Media
Tympanostomy
Additional relevant MeSH terms:
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Otitis
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases