Status:
COMPLETED
Non-Linear Imaging of Skin In Vivo
Lead Sponsor:
Enspectra Health
Collaborating Sponsors:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Conditions:
Skin Cancer
Skin Condition
Eligibility:
All Genders
2-90 years
Brief Summary
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.
Eligibility Criteria
Inclusion
- 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
- 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
- \-
Key Trial Info
Start Date :
March 28 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 6 2022
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT05410964
Start Date
March 28 2018
End Date
August 6 2022
Last Update
January 30 2024
Active Locations (1)
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1
Enspectra Health
Mountain View, California, United States, 94040