In Vivo Cross-Modal Imaging of Skin (VISION2)

Gabriel Sanchez

Status: Enrolling

Conditions: Skin

Treatments: Device: Skin conditions; Device: Skin Condition

Study type: Observational

Funder types: Industry; NIH

Identifiers

NCT07188948

5R44CA285138-02 (U.S. NIH Grant/Contract)

CR-30359

Details and patient eligibility

About

The overall objective of this study is to use VIO/FG-30350 ("VIO") to observe microscopic skin structure in people of different skin health at different anatomic locations and correlate microscopic features with macroscopic features.

Full description

The overall objective of this study is to use VIO/FG-30350 ("VIO") to observe microscopic skin structure in people of different skin health at different anatomic locations and correlate microscopic features with macroscopic features.

Enrollment: 15 estimated patients

Sex: All

Ages: 2 to 90 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Participants, ages 2 - 90 years old

Participant, 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.

Participant 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.

Participant and guardian, if applicable, must comply with the protocol requirements.

Participant 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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