Clinical Evaluation of the OtoSight | NCT03890107

Studies
Clinical Evaluation of the OtoSight

NCT03890107

Sponsor

PhotoniCare, Inc.

Status

Completed

Last Update Posted

May 22, 2023Actual

Enrollment

110Actual

Phase

Not provided

Conditions

Otitis Media

Interventions

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
R44DC014599	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

Apr 15, 2019Actual

Primary Completion Date

Apr 30, 2021Actual

Completion Date

Apr 30, 2022Actual

First Submitted Date

Mar 18, 2019

First Submission Date that Met QC Criteria

Mar 22, 2019

First Posted Date

Mar 26, 2019Actual

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

May 18, 2023

Last Update Posted Date

May 22, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

PhotoniCare, Inc.INDUSTRY

Collaborators

Name	Class
Carle Foundation Hospital	OTHER
Children's National Research Institute	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

Yes

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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

Retention

Enrollment

110Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pediatric tympanostomy tube patients		Patients diagnosed with otitis media and scheduled for tympanostomy tube placement will be imaged with the OtoSight	Device: OtoSight Middle Ear Scope

Interventions

Name	Type	Description	Arm Group Labels	Other Names
OtoSight Middle Ear Scope	Device	OtoSight imaging using a near-infrared laser	Pediatric tympanostomy tube patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
OtoSight imaging exam	Optical coherence tomography imaging to evaluate the middle ear.	1-5 minutes

Secondary Outcomes

Measure	Description	Time Frame
Adverse events	Rate of adverse events	Date of recruitment (day of surgery) to post-operative follow-up visit (approx. 1 month, but can be longer)

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

17 Years

Standard Ages

Child

Study Population

Children diagnosed with otitis media and scheduled for tympanostomy tube surgery.

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 National Health System		Washington D.C.	District of Columbia	20010	United States
Carle Foundation Hospital

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

Ancestor Terms

ID	Term
D004427	Ear Diseases
D010038	Otorhinolaryngologic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided