Non-Linear Imaging of Skin In Vivo | Clinical Trial

Key information

Conditions

Skin Cancer Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Neoplasms Neoplasms by Site Skin Abnormalities Skin Condition Skin Diseases Skin Lesion Skin Neoplasms Skin and Connective Tissue Diseases

Age range

2 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Enspectra Health

Mountain View, California, 94040, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subjects, ages 2 - 90 years old.
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.
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.
Subject and guardian, if applicable, must comply with the protocol requirements.
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

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
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)
Any known allergies to any materials used in the preparation of skin and/or device use
Has a temporary or permanent electrical implanted medical device

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Treatment and study plan

VIO System

Device

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

Primary outcomes

VIO System Imaging Performance

Time frame: 3 hours

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.
VIO System Image Quality

Time frame: 3 hours

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.

Sponsors and collaborators

Lead sponsor

Enspectra Health

Industry

Collaborators

National Cancer Institute (NCI)
National Institutes of Health (NIH)

Registry information

Official study title

Non-Linear Imaging of Skin In Vivo: VIO In Vivo Skin Imaging evaluatiON (VISION)

Acronym: VISION

Important dates

Study start: 2018
Primary completion: 2022
Study completion: 2022
First posted: Jun 8, 2022
Registry last updated: Jan 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed