NCT06463860

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

Retrospective, Multi-Center Study to Evaluate the Performance of DermDx as an Adjunctive Tool for Primary Care Physicians in the Detection of Skin Cancers

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 81 (actual)
• Sponsor: MetaOptima Technology Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Skin Cancer

Interventions

Type	Name	Description
DEVICE	DermDx	DermDx is a computer-aided diagnosis (CADx) software product that uses an AI-based algorithm to evaluate non-invasively captured images of skin lesions obtained from any commercially available dermoscopes. DermDx uses state-of-the-art deep neural network models that have been trained on a large database of dermoscopy images. DermDx analyzes the image of a new skin lesion and provides an output.

Timeline

• Start date: 2024-06-12
• Primary completion: 2024-11-27
• Completion: 2024-11-27
• First posted: 2024-06-18
• Last updated: 2024-12-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study