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At-Home Dermoscopy Artificial Intelligence

NCT05321784 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2025-12-29

Study results available
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Summary

This is a new protocol to analyze how the use of the Sklip System enables laypersons to safely triage self-selected pigmented skin lesions of concern (PSLCs) from home with the same or better accuracy than pre-specified performance goals for the detection of PSLCs that require biopsy (Melanoma and atypical melanocytic nevi with uncertain malignant, Squamous cell carcinoma, Basal cell carcinoma).

The study protocol will also compare the accuracy of the Sklip System when used by a layperson (Participant) versus near-perfect Sklip System user (Study Coordinator), assess whether Sklip System improves triage of PSLCs \< 6 mm in diameter and triage of thin melanomas with \<0.8 mm Breslow depth as suspicious, as compared to the current medical provider virtual triage method that relies on store-and-forward of smartphone clinical images (SCI), and assess accuracy of layperson-performed self-skin-exams (SSEs) at-home in the identification of all suspicious PSLCs present on their body as compared to the same layperson (Participant) evaluated with a full body skin examination (FBSE) by a dermatology Provider (DP) in-person.

Conditions

  • Malignant Skin Neoplasm

Interventions

OTHER

Dermoscopy

Take digital dermoscopy images (DDI)

OTHER

Digital Photography

Take smartphone clinical images (SCI)

PROCEDURE

Self-Skin Examination

Perform self-skin exam (SSE)

DEVICE

Skin Examination with Sklip

Apply Sklip System

PROCEDURE

Skin Examination

Undergo in-person full body skin examination (FBSE)

OTHER

Survey Administration

Ancillary studies

Sponsors & Collaborators

  • Oregon Health and Science University

    collaborator OTHER

  • OHSU Knight Cancer Institute

    lead OTHER

Principal Investigators

  • Sancy A. Leachman, MD, PhD · OHSU Knight Cancer Institute

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-27
Primary Completion
2024-09-30
Completion
2024-09-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT05321784 on ClinicalTrials.gov