Multi-Center Study to Evaluate the Performance of DermDx for Primary Care Physicians in the Detection of Skin Cancers

MetaOptima Technology Inc.

Status: Completed

Conditions: Skin Cancer

Treatments: Device: DermDx

Study type: Observational

Funder types: Industry

Identifiers

NCT06463860

Real-Dx

Details and patient eligibility

About

The proposed study is a pivotal, multi-center retrospective reader study designed to determine whether the use of DermDx as a concurrent reading aid improves the performance of primary care physicians (PCPs) in diagnosing skin cancers.

Full description

The proposed study is a pivotal, multi-center retrospective reader study designed to determine whether the use of DermDx as a concurrent reading aid improves the performance of primary care physicians (PCPs) in diagnosing skin cancers.

DermDx is a deep learning-based algorithm that analyzes lesion images to detect skin cancer. The software does not have dedicated hardware and can accept as input any dermoscopic images taken with commercial dermoscopes.

Because the study is designed to investigate the change in the performance of the PCPs before and after seeing the device output, a single-arm study design has been used.

Enrollment: 81 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• The subjects must be Primary Care Physicians who are board certified in family medicine or internal medicine.

Exclusion criteria

• Subjects not meeting inclusion criteria.

Trial design

81 participants in 1 patient group

Double reading of all cases with and without software output

Description:

Double reading of all cases with and without software output

Treatment:

Device: DermDx