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| ID | Type | Description | Link |
|---|---|---|---|
| 5R44CA285138-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 7 days |
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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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Recruitment Clinics and Healthy Participants
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Enspectra Health | Recruiting | Mountain View | California | 94040 | United States |
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