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| ID | Type | Description | Link |
|---|---|---|---|
| 2R44CA221591-03 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Cancer Institute (NCI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Arm |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VIO System | Device | To investigate the potential for the VIO System to display microscopic skin structure in people of different age, sex, race, and skin health |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 hours |
| 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. | 3 hours |
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Inclusion Criteria:
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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Healthy subjects, volunteers as well subjects with suspected skin condition recruited from dermatology clinics
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Enspectra Health | Mountain View | California | 94040 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29461771 | Background | Ward WH, Farma JM, editors. Cutaneous Melanoma: Etiology and Therapy [Internet]. Brisbane (AU): Codon Publications; 2017 Dec 21. Available from http://www.ncbi.nlm.nih.gov/books/NBK481860/ |
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| ID | Title | Description |
|---|---|---|
| FG000 | VIO Imaging | Healthy subjects, volunteers as well subjects with suspected skin condition recruited from dermatology clinics |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | VIO Imaging | Healthy subjects, volunteers as well subjects with suspected skin condition recruited from dermatology clinics |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | VIO System Imaging Performance assessment was conducted on images taken of all participants | Posted | Number | # participants with acceptable images | 3 hours |
|
1 week
See clinicaltrials.gov definition
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | VIO Imaging | Healthy subjects, volunteers as well subjects with suspected skin condition recruited from dermatology clinics |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| President | Enspectra Health | 650 480-6022 | clinical@enspectrahealth.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 6, 2022 | Oct 24, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012878 | Skin Neoplasms |
| D012871 | Skin Diseases |
| D012868 | Skin Abnormalities |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D017437 | Skin and Connective Tissue Diseases |
| D000013 | Congenital Abnormalities |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Fitzpatrick Skin Type | Fitzpatrick skin type is a demographic measure of skin pigment and sensitivity to sunlight, as self-reported by participants prior to the study procedure. The measure ranges from Type I (least pigment/most sensitive) to Type VI (most pigment/least sensitive). Refer to PubMed ID: 29461771 for the scale used. | Count of Participants | Participants |
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| Skin Health | Count of Participants | Participants |
|
Healthy subjects, volunteers as well subjects with suspected skin condition recruited from dermatology clinics
|
|
| 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. | VIO System Image Quality assessment was conducted on images taken of all participants | Posted | Number | # participants with acceptable images | 3 hours |
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|
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| 0 |
| 122 |
| 0 |
| 122 |
| 0 |
| 122 |
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| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |