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

NCT06463860 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 81

Last updated 2024-12-19

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • MetaOptima Technology Inc.

    lead INDUSTRY

Principal Investigators

  • Majid Razmara, PhD · MetaOptima Technology Inc.

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-12
Primary Completion
2024-11-27
Completion
2024-11-27
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06463860 on ClinicalTrials.gov