In Vivo Cross-Modal Imaging of Skin
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Skin conditions, Skin Condition.
- Who it may be relevant to
- Registry conditions: Skin. Basic parameters: 2 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
In Vivo Cross-Modal Imaging of Skin - VISION2
Overview
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.
Detailed description
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.
Interventions
- Device Skin conditions
Participants with skin conditions such as AK or participants without any skin conditions (healthy skin) - Device Skin Condition
Participants with Skin conditions or participants without any skin conditions (Healthy)
Primary outcome measures
- Correlational relationship [Time frame: 7 days]
- Correlational relationship [Time frame: 7 days]
Eligibility 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
\-
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Other
Study locations
United States · 1 center
- Enspectra Health — Mountain View
Identifiers
NCT: NCT07188948 · CR-30359 · 5R44CA285138-02