Clinical Evaluation of the TOMi Scope
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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: NCT03890107 |
Recruitment Status :
Recruiting
First Posted : March 26, 2019
Last Update Posted : April 17, 2019
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Condition or disease | Intervention/treatment |
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Otitis Media | Device: PhotoniCare TOMi Scope |
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 |

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
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Device: PhotoniCare TOMi Scope
PhotoniCare TOMi Scope imaging using a near-infrared laser |
- PhotoniCare TOMi Scope imaging exam [ Time Frame: 1-5 minutes ]Optical coherence tomography imaging to evaluate the middle ear.
- 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

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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 |
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

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
Contact: Ryan Nolan, M.Eng., CCRP | 866-411-3277 ext 1 | rnolan@photoni.care |
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 |
Principal Investigator: | Ryan Shelton, PhD | PhotoniCare, Inc. |
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 |
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 |
Ear Infection Ear tubes Myringotomy Otitis Media Tympanostomy |
Otitis Otitis Media Ear Diseases Otorhinolaryngologic Diseases |