Clinical Evaluation of the OtoSight

NCT ID: NCT03890107

Last Updated: 2023-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

110 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-15

Study Completion Date

2022-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Otitis Media

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Pediatric tympanostomy tube patients

Patients diagnosed with otitis media and scheduled for tympanostomy tube placement will be imaged with the OtoSight

OtoSight Middle Ear Scope

Intervention Type DEVICE

OtoSight imaging using a near-infrared laser

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

OtoSight Middle Ear Scope

OtoSight imaging using a near-infrared laser

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Carle Foundation Hospital

OTHER

Sponsor Role collaborator

Children's National Research Institute

OTHER

Sponsor Role collaborator

National Institute on Deafness and Other Communication Disorders (NIDCD)

NIH

Sponsor Role collaborator

PhotoniCare, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ryan Shelton, PhD

Role: PRINCIPAL_INVESTIGATOR

PhotoniCare, Inc.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Children's National Health System

Washington D.C., District of Columbia, United States

Site Status

Carle Foundation Hospital

Urbana, Illinois, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R44DC014599

Identifier Type: NIH

Identifier Source: secondary_id

View Link

000001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

SWIR Otoscopy Study
NCT06944795 NOT_YET_RECRUITING NA
Vaccination for Middle Ear Infection
NCT00001605 COMPLETED PHASE1