Enspectra Health
Mountain View, California, 94040, United States
Location status: Recruiting
Location contact
Bill Beasley
CONTACT
Esha J Kothari
CONTACT
Gabriel Sanchez, PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT07188948
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.
Interested in participating?
Request Info2 year–90 year
All sexes
Observational
Mountain View, California, 94040, United States
Location status: Recruiting
Bill Beasley
CONTACT
Esha J Kothari
CONTACT
Gabriel Sanchez, PhD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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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Participants with skin conditions such as AK or participants without any skin conditions (healthy skin)
Participants with Skin conditions or participants without any skin conditions (Healthy)
Time frame: 7 days
Correlational relationship of:
melanin content quantified from noninvasive VIO images with
macroscopic skin tone as measured with a colorimeter.
Time frame: 7 days
Correlational relationship of:
Gabriel Sanchez
Industry
In Vivo Cross-Modal Imaging of Skin - VISION2
Acronym: VISION2
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.
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