Non-Linear Imaging of Skin In Vivo

Enspectra Health122 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

122

Conditions

Skin Cancer Skin Condition Skin Diseases Skin Lesion Skin Abnormalities

Interventions

VIO SystemDEVICE

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

Eligibility

Sex: ALLMin age: 2 YearsMax age: 90 YearsHealthy volunteers:

Medical Language ↔ Plain English

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 \-

Locations (1)

Enspectra Health

Mountain View, California, United States

Outcomes

Primary Outcomes

VIO System Imaging Performance

Quantify imaging performance in various types of skin, which may include estimated in vivo resolution and imaging depth. Various types of skin includes skin of different people as well as skin in different locations on the body, and skin with skin disease, including basal cell carcinoma. VIO System device design characteristics were iterated during the study to optimize image quality across subjects with various skin types, body locations, and skin disease states. The outcome measure of device imaging performance (acceptable/not acceptable) was assessed through engineering expert review of VIO images. The engineering expert review determined whether images were of consistent quality.

Time frame: 3 hours

VIO System Image Quality

Qualitatively evaluate image quality and interpretability by physicians trained in dermatopathology as a function of skin type. VIO System device design characteristics were iterated during the study to optimize image quality across subjects with various skin types, body locations, and skin disease states. The outcome measure of device image quality (acceptable/not acceptable) was assessed through clinical expert review of VIO images. The clinical expert review determined whether VIO images could be interpreted by physicians trained in dermatopathology.

Time frame: 3 hours

Data from ClinicalTrials.gov

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