In Vivo Cross-Modal Imaging of Skin

NCT07188948 | Recruiting FDA Device

• 2 other identifiers: CR-303595R44CA285138-02
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Skin

Outcome Measures

Primary Outcomes (2)

• Correlational relationship

  Correlational relationship of: melanin content quantified from noninvasive VIO images with macroscopic skin tone as measured with a colorimeter.

  7 days

• Correlational relationship

  Correlational relationship of: 1. melanin content quantified from noninvasive VIO images with 2. macroscopic skin tone as measured with a colorimeter.

  7 days

Interventions

Skin conditions DEVICE

Participants with skin conditions such as AK or participants without any skin conditions (healthy skin)

Skin Condition DEVICE

Participants with Skin conditions or participants without any skin conditions (Healthy)

Eligibility Criteria

• Age: 2 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Recruitment Clinics and Healthy Participants

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gabriel Sanchez: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Enspectra Health

Mountain View, California, 94040, United States

RECRUITING

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: CEO

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: September 23, 2025
• Study Start: September 2, 2025
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)