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DermaSensor Postmarket Surveillance Study

NCT06666790 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 396

Last updated 2024-10-31

No results posted yet for this study

Summary

The objective of this study is to evaluate the sensitivity of the DermaSensor device and Investigators when used on skin lesions concerning for melanoma.

Conditions

  • Melanoma, Skin

Interventions

DEVICE

Scan with elastic scattering spectroscopy device to assess risk of malignancy

Elastic scattering spectroscopy device uses a spectrum of light reflectance to compare suspicious lesion signature to that of previously scanned lesions with known benign or malignant pathology

Sponsors & Collaborators

  • DermaSensor, Inc.

    lead INDUSTRY

Principal Investigators

  • Gary Slatko, MD, MBA · DermaSensor, Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
SCREENING
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-08
Primary Completion
2027-04-11
Completion
2027-09-10
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT06666790 on ClinicalTrials.gov