Non-Linear Imaging of Skin In Vivo

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

122 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-28

Study Completion Date

2022-08-06

Brief Summary

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The overall objective of this study is to investigate the potential for the VIO System to display microscopic skin structure in people of different age, sex, race, and skin health.

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Detailed Description

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Conditions

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Skin Cancer Skin Condition Skin Diseases Skin Lesion Skin Abnormalities

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Single Arm

VIO System

Intervention Type DEVICE

To investigate the potential for the VIO System to display microscopic skin structure in people of different age, sex, race, and skin health

Interventions

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VIO System

To investigate the potential for the VIO System to display microscopic skin structure in people of different age, sex, race, and skin health

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Subjects, ages 2 - 90 years old.
2. Subject, or guardian, if applicable, must be willing to provide written informed consent prior to enrollment and agree to comply with protocol requirements. If applicable, child must be willing to provide written assent prior to enrollment and agree to comply with protocol requirements.
3. Subject or guardian, if applicable, must have sufficient mental capacity to understand the Informed Consent and provide clinically relevant and reliable feedback regarding their experience with the device.
4. Subject and guardian, if applicable, must comply with the protocol requirements.
5. Subject or guardian, if applicable, must agree that anonymized personal data will be made available to Study Sponsor and requisite regional and international regulatory bodies.

Exclusion Criteria

1. Any general health condition or systemic disease that may represent, in the opinion of the Principal Investigator, a potential increased risk associated with device use
2. Currently infected with a communicable skin infection (e.g., shingles or methicillin-resistant S. aureus), which does not include local and minimally pathogenic or non-pathogenic infections distant from the imaging location(s) (e.g., warts, acne)
3. Any known allergies to any materials used in the preparation of skin and/or device use
4. Has a temporary or permanent electrical implanted medical device

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Minimum Eligible Age

2 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes