A Skin Image Reference Tool to Aid Healthcare Providers' Diagnosis

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age10+
SponsorWake Forest University Health Sciences

About this trial

Consented patients will have three images taken of their dermatologic conditions within the Belle.ai software. These images will be uploaded and saved within the Belle software system where a single AI-generated differential list will be generated based on the three photos. All photos uploaded will be de-identified. The software will not have any unique identifiers of participants saved in the system. The photos will be named based on participant enrollment numbers or unique code numbers and no unique identifiers will be attached to the photos. There will be no data collection form necessary for this study

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patient must present to an Advocate Health dermatology clinic

Patient must have the ability and willingness to provide informed consent and comply with study procedures and visits

Participant dermatologists must have access to the required technology (e.g., smartphone with internet access) and be capable of using it for the required image capture

Disqualifiers

Patients who are unable to comply with study procedures due to physical or mental health limitations (as assessed by study coordinator)

Pediatric, adolescent, and teen patients who present with dermatological conditions on their genitalia will not be included in the study (in support of patient privacy concerns).

Trial population

Up to 400 participants will be recruited for this study

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

400 Participants
are grouped into 1 trial group
Group A: Patient at Advocate Health dermatology clinic

Trial outcomes

Primary outcomes

1

concordance of Belle.ai diagnoses with physician diagnoses.

The study coordinator will review uploaded patient "cases" and assign them for review and adjudication to designated Dermatologic Review Committee (DRC) members within the Belle web portal. The DRC will be comprised of 1-2 Advocate Health board-certified dermatologists from each of the Winston, Charlotte, and Midwest dermatology practices.

Time frame
Day 1

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wake Forest University Health Sciences

Lead sponsor

BelleTorus Corporation

Collaborator