Clinical Development of Deep Learning for the OtoSight | NCT04722770

Studies
Clinical Development of Deep Learning for the OtoSight

NCT04722770

Sponsor

PhotoniCare, Inc.

Status

Completed

Last Update Posted

Jan 23, 2024Actual

Enrollment

188Actual

Phase

Not provided

Conditions

Otitis Media Acute

Interventions

PhotoniCare OtoSight Middle Ear Scope

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
R44DC017422	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

May 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 19, 2021Actual

Primary Completion Date

Sep 2, 2022Actual

Completion Date

Aug 31, 2023Actual

First Submitted Date

Jan 20, 2021

First Submission Date that Met QC Criteria

Jan 20, 2021

First Posted Date

Jan 25, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 22, 2024

Last Update Posted Date

Jan 23, 2024Actual

Name	Class
University of Pittsburgh	OTHER
National Institute on Deafness and Other Communication Disorders (NIDCD)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The objective of this study is to clinically develop and evaluate a machine learning approach to improve the performance and data interpretation of the PhotoniCare OtoSight Middle Ear Scope in pediatric patients presenting at the primary care office for suspected ear infections. In this observational study, results of OtoSight imaging will not affect patient standard of care.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

188Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pediatric patients with possible ear infections		Pediatric patients presenting with otitis media (acute otitis media or otitis media with effusion) will be imaged with the PhotoniCare OtoSight.	Device: PhotoniCare OtoSight Middle Ear Scope

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PhotoniCare OtoSight Middle Ear Scope	Device	PhotoniCare OtoSight imaging using a near-infrared laser	Pediatric patients with possible ear infections

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
PhotoniCare OtoSight imaging exam	Optical coherence tomography imaging to evaluate the middle ear.	1-5 minutes; at first and only study visit

Secondary Outcomes

Measure	Description	Time Frame
Adverse events	Rate of adverse events	15-30 minutes; at first and only study visit

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pediatric patients presenting for an office visit with ear-related complaints

Exclusion Criteria:

Otoscopy contra-indicated or not possible per attending clinician's decision, Down's syndrome (due to abnormalities in ear canal anatomy)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Months

Maximum Age

4 Years

Standard Ages

Child

Study Population

Children presenting to the pediatric clinic with suspected ear infection

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ryan Shelton, PhD	PhotoniCare, Inc.	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Children's Hospital of Pittsburgh		Pittsburgh	Pennsylvania	15213	United States

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010033	Otitis Media
D010031	Otitis
D010034	Otitis Media with Effusion

Ancestor Terms

ID	Term
D004427	Ear Diseases
D010038	Otorhinolaryngologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided