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NCT05940090 Clinical Trial

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

Skin Lesion Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05940090
Other study ID # Halc-1-ai
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 3, 2023
Est. completion date October 8, 2023

Study information
Verified date September 2023
Source Halcyon Dermatology
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 23
Est. completion date October 8, 2023
Est. primary completion date October 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria: - Males and females participants in overall good health ages 18 to 85 who have skin lesions Exclusion Criteria: - Those who are under 18 or over 85

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• SkinIO
The device is simply an application that photographs skin lesions and identifies lesions that may require further examination

Locations
Country Name City State
United States Halcyon Dermatology Laguna Hills California

Sponsors (1)
Lead Sponsor Collaborator
Halcyon Dermatology

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Dermatologist made biopsy decision compared to AI outlier lesions Patient will undergo total body photography that marks outlier lesions. Without reviewing the photos, a dermatologist will make recommendations for which lesions should undergo skin biopsy. Three months
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