Otitis MediaNCT03890107
Clinical Evaluation of the OtoSight
An observational study of Otitis Media, run by PhotoniCare, Inc. at 2 sites in United States.
Trial summary
The objective of this study is to evaluate the imaging capabilities and image analysis performance of the OtoSight Middle Ear Scope in pediatric patients undergoing tympanostomy tube placement for otitis media. In this observational study, results of OtoSight imaging will not affect patient standard of care. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Otitis Media
- What is being tested?
- OtoSight Middle Ear Scope
- Type of treatment
- Medical device
- How many people
- 110 participants
- Where
- 2 sitesUnited States
- Study dates
- 15 Apr 2019to 30 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Children diagnosed with otitis media and scheduled for tympanostomy tube surgery.
Who may be able to join
- Children (17 years old or younger) scheduled for tympanostomy tube placement
Who cannot join
- Otoscopy contra-indicated or not possible per attending physician's decision
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Carle Foundation Hospital
Urbana, Illinois, 61801
Children's National Health System
Washington D.C., District of Columbia, 20010
About this study
Official title: Clinical Evaluation of a New Middle Ear Diagnostic to Support FDA Regulatory Clearance
The objective of this study is to evaluate the imaging capabilities and image analysis performance of the OtoSight Middle Ear Scope in pediatric patients undergoing tympanostomy tube placement for otitis media. In this observational study, results of OtoSight imaging will not affect patient standard of care.
- Conditions
- Otitis Media
- Being tested
- OtoSight Middle Ear Scope
- Keywords
- Ear Infection, Ear tubes, Myringotomy, Otitis Media, Tympanostomy
- Medical subject headings
- Otitis Media, Otitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OtoSight Middle Ear ScopeDevice
OtoSight imaging using a near-infrared laser
| Study group | Role | What they receive |
|---|---|---|
| Pediatric tympanostomy tube patients | Patients diagnosed with otitis media and scheduled for tympanostomy tube placement will be imaged with the OtoSight Receives: Device: OtoSight Middle Ear Scope |
What is being measured
The primary outcome is the main question the study is designed to answer.
OtoSight imaging exam
Optical coherence tomography imaging to evaluate the middle ear.
Measured: 1-5 minutes
Secondary outcomes (1)
Adverse events
Rate of adverse events
Measured: Date of recruitment (day of surgery) to post-operative follow-up visit (approx. 1 month, but can be longer)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study start15 Apr 2019
- Primary completion30 Apr 2021
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Otitis MediaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- PhotoniCare, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Carle Foundation Hospital, Children's National Research Institute, National Institute on Deafness and Other Communication Disorders (NIDCD)
- Responsible party
- Sponsor
- Investigators
- Ryan Shelton, PhD, Principal investigator, PhotoniCare, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03890107
- Sponsor's protocol ID
- 000001
- Other IDs
- R44DC014599
- Status last verified
- May 2023
- First submitted
- 18 Mar 2019
- Last updated
- 22 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of a New Middle Ear Diagnostic to Support FDA Regulatory Clearance
- ClinicalTrials.gov ID
- NCT03890107
- Acronym / sponsor ID
- 000001
- Conditions
- Otitis Media
- Keywords
- Ear Infection, Ear tubes, Myringotomy, Otitis Media, Tympanostomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- PhotoniCare, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Carle Foundation Hospital, Children's National Research Institute, National Institute on Deafness and Other Communication Disorders (NIDCD)
- Study start
- 15 Apr 2019 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 26 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the imaging capabilities and image analysis performance of the OtoSight Middle Ear Scope in pediatric patients undergoing tympanostomy tube placement for otitis media. In this observational study, results of OtoSight imaging will not affect patient standard of care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric tympanostomy tube patients | – | Device: OtoSight Middle Ear ScopePatients diagnosed with otitis media and scheduled for tympanostomy tube placement will be imaged with the OtoSight |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children diagnosed with otitis media and scheduled for tympanostomy tube surgery.
Key inclusion criteria (1 listed)
- Children (17 years old or younger) scheduled for tympanostomy tube placement
Key exclusion criteria (1 listed)
- Otoscopy contra-indicated or not possible per attending physician's decision
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OtoSight Middle Ear ScopeOtoSight imaging using a near-infrared laser | Device | Pediatric tympanostomy tube patients |
Primary outcome
OtoSight imaging exam
Time frame: 1-5 minutes
Optical coherence tomography imaging to evaluate the middle ear.
1 secondary outcome
Adverse events
Time frame: Date of recruitment (day of surgery) to post-operative follow-up visit (approx. 1 month, but can be longer)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2023.
- Individual participant dataSharing planned: No
Related trials for Otitis Media
Active, not recruiting
In-Office Clinical Study of the Solo+ TTD
Ear Infection, Otitis Media
Recruiting
CLIKX® Tympanostomy Tube Delivery System for the Placement of Tympanostomy Tubes
Otitis Media, Otitis Media Chronic
Not yet recruiting
Short-term Application of Lactoferrin Ventilation Tubes
Otitis Media With Effusion (OME)
Recruiting
Nasopharyngeal Carriage of S. Pneumoniae
Nasopharyngeal Carriage, Children, Only
Recruiting
Platelet-Rich Fibrin in Revision Cartilage Tympanoplasty
Tympanic Membrane Perforation, Chronic Otitis Media
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ryan Shelton, PhD principal investigator
PhotoniCare, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Otitis Media, run by PhotoniCare, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OtoSight imaging exam (time frame: 1-5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2023.