Cross-modal in vivo imaging of skin microstructure
In Vivo Cross-Modal Imaging of Skin - VISION2
This project will use a handheld imaging device (VIO/FG-30350) to see if microscopic skin features correspond to visible skin appearance in people aged 2 to 90 with different skin health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 15 (estimated) |
| Ages | 2 Years to 90 Years |
| Sex | All |
| Sponsor | Enspectra Health Industry-sponsored |
| Locations | 1 site (Mountain View, California) |
| Trial ID | NCT07188948 on ClinicalTrials.gov |
What this trial studies
This observational study uses the VIO/FG-30350 device to capture microscopic images of skin at multiple anatomic locations in participants with a range of skin health. Investigators will compare those microscopic features with macroscopic (visible) skin characteristics to identify correlations. Participants aged 2–90 who can consent (or whose guardians can consent) and provide feedback will undergo noninvasive imaging during study visits. Anonymized data will be shared with the sponsor and regulatory bodies for analysis.
Who should consider this trial
Good fit: Ideal candidates are people aged 2–90 with varying skin health who can provide informed consent (or have a guardian provide consent), comply with protocol visits, and give feedback about device use.
Not a fit: People seeking therapeutic treatment benefit, those with general health conditions that increase procedural risk, or those unable to consent or comply with protocol procedures are unlikely to receive direct benefit.
Why it matters
Potential benefit: If successful, this could improve noninvasive skin evaluation by linking microscopic imaging patterns to visible clinical signs, aiding earlier and more precise diagnosis or monitoring.
How similar studies have performed: Related noninvasive microscopic skin imaging methods (such as reflectance confocal microscopy and OCT) have clinical precedent, but using VIO/FG-30350 for cross-modal correlation of microscopic and macroscopic features is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 \-
Where this trial is running
Mountain View, California
- Enspectra Health — Mountain View, California, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.