Skin Abnormalities, Skin Cancer, Skin Condition, Skin Diseases, Skin Lesion
Conditions
Brief summary
To demonstrate the safety and effectiveness of the VIO device in obtaining in vivo images that show tissue features including epidermis, dermis, collagen, blood vessels, and/or pigment. To demonstrate that the tissue features identified on the images obtained with the VIO device align with the corresponding pathology images procured from the skin biopsy. To evaluate the ability of blinded readers to correctly identify tissue features on images obtained with the VIO device.
Interventions
DEVICEVIO Imaging
Skin conditions that are candidates for skin biopsies
Sponsors
National Cancer Institute (NCI)
National Institutes of Health (NIH)
Enspectra Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
1. The subject is between 18 and 99 years of age. 2. The subject or Legally Authorized Representative (LAR) is able and willing to provide written informed consent. 3. The subject is planning to undergo a routine skin biopsy. 4. The subject is willing and able to remain still for periods of up to 3 minutes to allow for image capture. 5. The subject or LAR has sufficient mental capacity to understand the informed consent form (ICF) and comply with the protocol requirements.
Exclusion criteria
1. The subject has a general health condition or systemic disease that in the opinion of the physician, precludes them from trial participation. 2. The subject has a known allergy or increased skin sensitivity to silicone, adhesives, or glycerin. 3. The subject's lesion targeted for biopsy: 1. Is located on the palms of the hands, soles of the feet, fingernails, or toenails. 2. Has dense hair that will not be removed prior to the skin biopsy. 3. Has clinically significant abraded or ulcerated skin with or without discharge. 4. Is associated with a wound or skin condition that in the opinion of the physician precludes them from participation 5. Is located in mucosal tissue (i.e., oral, nasal, etc.). 6. Is on tattooed skin. 7. Is on a skin formation too tortuous for the investigational device to access (e.g., skin tags.) 8. Is located in the periorbital region or directly on the eyelid. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparative Reader Percentage Agreement | 8 months post-enrollment completion | This outcome measured the % agreement and validation of specific tissue features on VIO images in comparison to gold standard pathology images between N=3 Comparative Readers (CRs). CRs were study investigators that were selected based on their experience and medical qualifications. 100% agreement and validation between the CRs was required to proceed to the next study phase. |
| Blinded Reader Percentage Agreement | 8 months post-enrollment completion | This outcome measured the % agreement between N=3 Blinded Readers (BRs) of their assessment of VIO images in comparison to the answer key developed from the Comparative Reader validation. BRs were study investigators that were selected based on their experience and medical qualifications. \>90% agreement was required to proceed to the next study phase. |
| Safety / Adverse Events | 7 +/- 3 days after VIO imaging | Safety will be assessed as the incidence of all adverse events (analyzed by severity, seriousness, and relationship to the device and procedure) that occur through the 7-day follow-up period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inter-Reader Percentage Agreement | 8 months post-enrollment completion | This outcome measured the inter-reader % agreement between N=3 Blinded Readers (BRs) during image analysis. Minimum 90% agreement was required to proceed to the next study phase. |
| Evaluation of Secondary Histopathology Characteristics | 8 months post-enrollment completion | This outcome measured the % agreement between N=3 Blinded Readers (BRs) of their assessment of secondary histopathology characteristics in VIO images in comparison to the answer key developed from the Comparative Reader validation. \>90% agreement was required to proceed to the next study phase. |
Countries
United States
Participant flow
Recruitment details
Enrollment Period: 22-Oct-2022 t0 29-Dec-2022
Participants by arm
| Arm | Count |
|---|---|
| VIO Imaging Adult subjects between 18 and 99 years of age willing and able to provide written informed consent either themselves or by their legally authorized representative (LAR) and planning to undergo a routine skin biopsy and adhere to study specific requirements. | 65 |
| Total | 65 |
Baseline characteristics
| Characteristic | VIO Imaging |
|---|---|
| Age, Continuous | 66 years STANDARD_DEVIATION 16 |
| Anatomical Location Head and Neck | 38 Participants |
| Anatomical Location Limbs | 21 Participants |
| Anatomical Location Torso | 6 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 56 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Fitzpatrick Skin Type Type I | 6 Participants |
| Fitzpatrick Skin Type Type II | 18 Participants |
| Fitzpatrick Skin Type Type III | 27 Participants |
| Fitzpatrick Skin Type Type IV | 11 Participants |
| Fitzpatrick Skin Type Type V | 3 Participants |
| Fitzpatrick Skin Type Type VI | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 64 Participants |
| Region of Enrollment United States | 65 Participants |
| Sex: Female, Male Female | 27 Participants |
| Sex: Female, Male Male | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 65 |
| other Total, other adverse events | 0 / 65 |
| serious Total, serious adverse events | 0 / 65 |
Outcome results
Primary
Blinded Reader Percentage Agreement
This outcome measured the % agreement between N=3 Blinded Readers (BRs) of their assessment of VIO images in comparison to the answer key developed from the Comparative Reader validation. BRs were study investigators that were selected based on their experience and medical qualifications. \>90% agreement was required to proceed to the next study phase.
Time frame: 8 months post-enrollment completion
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Training Set | Blinded Reader Percentage Agreement | 94 percentage of agreement |
Primary
Comparative Reader Percentage Agreement
This outcome measured the % agreement and validation of specific tissue features on VIO images in comparison to gold standard pathology images between N=3 Comparative Readers (CRs). CRs were study investigators that were selected based on their experience and medical qualifications. 100% agreement and validation between the CRs was required to proceed to the next study phase.
Time frame: 8 months post-enrollment completion
Population: Comparative Reader Agreement and Validation was conducted on images taken of all participants
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Training Set | Comparative Reader Percentage Agreement | 100 percentage of agreement |
| Validation Set | Comparative Reader Percentage Agreement | 100 percentage of agreement |
Primary
Safety / Adverse Events
Safety will be assessed as the incidence of all adverse events (analyzed by severity, seriousness, and relationship to the device and procedure) that occur through the 7-day follow-up period.
Time frame: 7 +/- 3 days after VIO imaging
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Training Set | Safety / Adverse Events | 0 adverse events |
Secondary
Evaluation of Secondary Histopathology Characteristics
This outcome measured the % agreement between N=3 Blinded Readers (BRs) of their assessment of secondary histopathology characteristics in VIO images in comparison to the answer key developed from the Comparative Reader validation. \>90% agreement was required to proceed to the next study phase.
Time frame: 8 months post-enrollment completion
Population: Performance testing on secondary features (Stratum corneum, Hair shaft or follicle, Solar elastosis, Hyperkeratosis, Nodule or nest of cells, Atypia, Epidermal disarray) was conducted using 179 test questions
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Training Set | Evaluation of Secondary Histopathology Characteristics | 98 percentage of agreement |
Secondary
Inter-Reader Percentage Agreement
This outcome measured the inter-reader % agreement between N=3 Blinded Readers (BRs) during image analysis. Minimum 90% agreement was required to proceed to the next study phase.
Time frame: 8 months post-enrollment completion
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Training Set | Inter-Reader Percentage Agreement | Region | 94 percentage of agreement |
| Training Set | Inter-Reader Percentage Agreement | Feature | 93 percentage of agreement |