Skin Abnormalities, Skin Cancer, Skin Condition, Skin Diseases, Skin Lesion
Conditions
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.
Interventions
DEVICEVIO System
To investigate the potential for the VIO System to display microscopic skin structure in people of different age, sex, race, and skin health
Sponsors
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Enspectra Health
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
2 Years to 90 Years
Healthy volunteers
Yes
Inclusion criteria
1. Subjects, ages 2 - 90 years old. 2. 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. 3. 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. 4. Subject and guardian, if applicable, must comply with the protocol requirements. 5. 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 criteria
1. 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 2. 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) 3. Any known allergies to any materials used in the preparation of skin and/or device use 4. Has a temporary or permanent electrical implanted medical device \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VIO System Imaging Performance | 3 hours | Quantify imaging performance in various types of skin, which may include estimated in vivo resolution and imaging depth. Various types of skin includes skin of different people as well as skin in different locations on the body, and skin with skin disease, including basal cell carcinoma. VIO System device design characteristics were iterated during the study to optimize image quality across subjects with various skin types, body locations, and skin disease states. The outcome measure of device imaging performance (acceptable/not acceptable) was assessed through engineering expert review of VIO images. The engineering expert review determined whether images were of consistent quality. |
| VIO System Image Quality | 3 hours | Qualitatively evaluate image quality and interpretability by physicians trained in dermatopathology as a function of skin type. VIO System device design characteristics were iterated during the study to optimize image quality across subjects with various skin types, body locations, and skin disease states. The outcome measure of device image quality (acceptable/not acceptable) was assessed through clinical expert review of VIO images. The clinical expert review determined whether VIO images could be interpreted by physicians trained in dermatopathology. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| VIO Imaging Healthy subjects, volunteers as well subjects with suspected skin condition recruited from dermatology clinics | 122 |
| Total | 122 |
Baseline characteristics
| Characteristic | VIO Imaging |
|---|---|
| Age, Continuous | 47 years STANDARD_DEVIATION 19 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 111 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Fitzpatrick Skin Type Type I | 6 Participants |
| Fitzpatrick Skin Type Type II | 30 Participants |
| Fitzpatrick Skin Type Type III | 46 Participants |
| Fitzpatrick Skin Type Type IV | 25 Participants |
| Fitzpatrick Skin Type Type V | 5 Participants |
| Fitzpatrick Skin Type Type VI | 1 Participants |
| Fitzpatrick Skin Type Unknown | 9 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 20 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants |
| Race (NIH/OMB) More than one race | 9 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 84 Participants |
| Region of Enrollment United States | 122 participants |
| Sex: Female, Male Female | 47 Participants |
| Sex: Female, Male Male | 75 Participants |
| Skin Health Healthy | 90 Participants |
| Skin Health Suspected or known skin diseases | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 122 |
| other Total, other adverse events | 0 / 122 |
| serious Total, serious adverse events | 0 / 122 |
Outcome results
Primary
VIO System Image Quality
Qualitatively evaluate image quality and interpretability by physicians trained in dermatopathology as a function of skin type. VIO System device design characteristics were iterated during the study to optimize image quality across subjects with various skin types, body locations, and skin disease states. The outcome measure of device image quality (acceptable/not acceptable) was assessed through clinical expert review of VIO images. The clinical expert review determined whether VIO images could be interpreted by physicians trained in dermatopathology.
Time frame: 3 hours
Population: VIO System Image Quality assessment was conducted on images taken of all participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VIO Imaging | VIO System Image Quality | 122 # participants with acceptable images |
Primary
VIO System Imaging Performance
Quantify imaging performance in various types of skin, which may include estimated in vivo resolution and imaging depth. Various types of skin includes skin of different people as well as skin in different locations on the body, and skin with skin disease, including basal cell carcinoma. VIO System device design characteristics were iterated during the study to optimize image quality across subjects with various skin types, body locations, and skin disease states. The outcome measure of device imaging performance (acceptable/not acceptable) was assessed through engineering expert review of VIO images. The engineering expert review determined whether images were of consistent quality.
Time frame: 3 hours
Population: VIO System Imaging Performance assessment was conducted on images taken of all participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| VIO Imaging | VIO System Imaging Performance | 122 # participants with acceptable images |