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

NCT ID: NCT05940090

Last Updated: 2024-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

23 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-03

Study Completion Date

2023-10-08

Brief Summary

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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

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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

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Skin Lesion

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Comparison of outlier analysis with dermatologist made biopsy decisions

Skin lesions recommended for skin biopsy by the dermatologist will be compared to lesions highlighted by the application outlier analysis.

SkinIO

Intervention Type DEVICE

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

Interventions

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SkinIO

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Halcyon Dermatology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Halcyon Dermatology

Laguna Hills, California, United States

Site Status

Countries

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United States

Other Identifiers

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Halc-1-ai

Identifier Type: -

Identifier Source: org_study_id

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