NCT05940090

Correlation of Dermatologist Made Biopsy Decision With AI Assisted Total Body Photography Detection of Outlier Lesions

Correlation of Dermatologist Made Biopsy Decisions With Artificial Intelligence (AI) Assisted Total Body Photography Detection of Outlier Lesions

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 23 (actual)
• Sponsor: Halcyon Dermatology · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

Summary

This research study will determine how a smart phone application (app) for total body photography outlier analysis compares to a dermatologist's decision to biopsy skin lesions.

Detailed description

Informed written consent will be obtained by all study subjects. Each participant will be asked to generate a unique identifier, so their demographic data, medical intake, and study assessments can be stored without any patient identifiers. The unique identifier is the participant's 2-digit day of birth, first 3 initials of their mother's maiden name, and the 4 digits of their birth year. All clinical data will be entered into a de- identified database. Demographic information including age, gender, ethnicity, collected via medical intake survey at the initial visit. Data from the survey will be associated only with the patient's unique identifiers.

Conditions

• Skin Lesion

Interventions

Type	Name	Description
DEVICE	SkinIO	The device is simply an application that photographs skin lesions and identifies lesions that may require further examination

Timeline

• Start date: 2023-07-03
• Primary completion: 2023-10-01
• Completion: 2023-10-08
• First posted: 2023-07-11
• Last updated: 2024-02-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study