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| ID | Type | Description | Link |
|---|---|---|---|
| 2R44CA221591-03 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| National Institutes of Health (NIH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VIO Imaging | Experimental | Subjects with skin conditions that are candidates for biopsy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VIO Imaging | Device | Skin conditions that are candidates for skin biopsies |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 8 months post-enrollment completion |
| 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. | 8 months post-enrollment completion |
| 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. | 7 +/- 3 days after VIO imaging |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 8 months post-enrollment completion |
| Evaluation of Secondary Histopathology Characteristics |
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Inclusion Criteria:
Exclusion Criteria:
The subject has a general health condition or systemic disease that in the opinion of the physician, precludes them from trial participation.
The subject has a known allergy or increased skin sensitivity to silicone, adhesives, or glycerin.
The subject's lesion targeted for biopsy:
Is located on the palms of the hands, soles of the feet, fingernails, or toenails.
Has dense hair that will not be removed prior to the skin biopsy.
Has clinically significant abraded or ulcerated skin with or without discharge.
Is associated with a wound or skin condition that in the opinion of the physician precludes them from participation
Is located in mucosal tissue (i.e., oral, nasal, etc.).
Is on tattooed skin.
Is on a skin formation too tortuous for the investigational device to access (e.g., skin tags.)
Is located in the periorbital region or directly on the eyelid.
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| Name | Affiliation | Role |
|---|---|---|
| Michael Wang, MD, FAAD | Golden State Dermatology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Golden State Dermatology | Merced | California | 95340 | United States | ||
| Golden State Dermatology |
| 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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Enrollment Period:
22-Oct-2022 t0 29-Dec-2022
| ID | Title | Description |
|---|---|---|
| FG000 | VIO Imaging | Skin conditions that are candidates for skin biopsies |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Subjects that are planning to undergo a routine skin biopsy
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | 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. | Comparative Reader Agreement and Validation was conducted on images taken of all participants | Posted | Number | percentage of agreement | 8 months post-enrollment completion | Images | Images |
|
7+/-3 days after enrollment
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 | Adult subjects with skin conditions that are candidates for routine skin biopsies |
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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 | Mar 15, 2023 | May 28, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D012868 | Skin Abnormalities |
| D012878 | Skin Neoplasms |
| ID | Term |
|---|---|
| D017437 | Skin and Connective Tissue Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D009371 | Neoplasms by Site |
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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. |
| 8 months post-enrollment completion |
| Walnut Creek |
| California |
| 94598 |
| United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| 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 |
|
| Anatomical Location | Count of Participants | Participants |
|
| Validation Set |
248 lesions from 39 subjects (1 lesion per subject) were selected as Validation Set Data to evaluate this primary outcome measure |
|
|
| 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. | Posted | Number | percentage of agreement | 8 months post-enrollment completion | Questions | Questions |
|
|
|
| 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. | Posted | Number | adverse events | 7 +/- 3 days after VIO imaging |
|
|
|
| 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. | Posted | Number | percentage of agreement | 8 months post-enrollment completion | Questions | Questions |
|
|
|
| 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. | 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 | Posted | Number | percentage of agreement | 8 months post-enrollment completion | Questions | Questions |
|
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| 0 |
| 65 |
| 0 |
| 65 |
| 0 |
| 65 |
Consultant (PI) shall not, either during or subsequent to the Term of the Agreement, directly or indirectly publish any such information (Proprietary Information) without the prior written authorization from Company (Sponsor).
| D009369 | Neoplasms |