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The overall goal of this research is to develop a platform that can increase patient access to expert skin cancer diagnostic services via telemedicine. This is especially important for medically underserved areas where melanoma outcomes are worse than in areas with greater access to in-person evaluations. If successful, the widespread availability of such services would be combined with public education efforts to encourage individuals with changing skin lesions to seek evaluation. With decreased travel times to high quality diagnostic services, such efforts may decrease the diagnosis of more advanced melanomas (with a concomitant increase in the diagnosis of earlier stage tumors), and potentially decrease melanoma mortality.
This is a prospective pilot study of a store-and-forward telemedicine diagnostic assessment of participant-selected skin lesions concerning for skin cancer, controlled against an in-person dermatologist assessment (gold standard evaluation). The study will be a single arm design with each participant undergoing telemedicine data acquisition (i.e. clinical and dermoscopic imaging and Nevisense measurement), immediately followed by the in-person dermatologist assessment. The in-person dermatologist will be blinded to the Nevisense score at the time of the visit. Using the telemedicine data, the teledermatology team will render a biopsy/no-biopsy recommendation within 3 business days of the participant evaluation. They will be blinded to the results of the in-person dermatologist's diagnostic evaluation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with skin lesions | Experimental | Participants who have up to 3 concerning skin lesions will be evaluated by both an in-person dermatologist and a team of three teledermatologists(board-certified dermatologists). The teledermatoogy team will deliver a consensus recommendation. If either the in-person dermatologist or teledermatologists are concerned that the skin spot(s) may be a skin cancer, a biopsy will be recommended and can be performed at no charge. Or if both agree that the spot(s) are not concerning for skin cancer, no biopsy will be needed. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nevisense 3.0 | Device | Nevisense, an AI-based point-of-care system for the non-invasive evaluation of irregular moles remains the only FDA approved system available for melanoma detection in the US. Nevisense 3.0 will be used as a one-time exposure of <8 seconds per lesion. Disposable electrodes that contact the participant are 5mm x 5mm in size. Nevisense 3.0 measures electrical impedance of skin lesions and provides an output called the electrical impedence spectroscopy (EIS) score. Electrical impedance is a measure of a material's overall resistance to the flow of alternating electric currents of various frequencies. The principle is that electrical impedance is different in normal versus abnormal tissue. |
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of Skin Cancer Diagnosis: In-Person Assessment | To compare the accuracy of skin cancer diagnoses between in-person recommendation and the telemedicine (tele) recommendation, the number of "positive" evaluations (i.e. recommended for biopsy) that were truly skin cancer plus the number of "negative" evaluations (i.e. not recommended for biopsy) that were truly non-cancerous divided by the total number of skin lesions evaluated is calculated. | End of the study (4 weeks) |
| Accuracy of Skin Cancer Diagnosis: Telemedicine Without Nevisense | To compare the accuracy of skin cancer diagnoses between in-person recommendation and the telemedicine (tele) recommendation, the number of "positive" evaluations (i.e. recommended for biopsy) that were truly skin cancer plus the number of "negative" evaluations (i.e. not recommended for biopsy) that were truly non-cancerous divided by the total number of skin lesions evaluated is calculated. | End of the study (4 weeks) |
| Accuracy of Skin Cancer Diagnosis: Telemedicine With Nevisense | To compare the accuracy of skin cancer diagnoses between in-person recommendation and the telemedicine (tele) recommendation, the number of "positive" evaluations (i.e. recommended for biopsy) that were truly skin cancer plus the number of "negative" evaluations (i.e. not recommended for biopsy) that were truly non-cancerous divided by the total number of skin lesions evaluated is calculated. | End of the study (4 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of Telemedicine Evaluation in Diagnosing Skin Cancer: Without Nevisense | Assessment of the dermatologist's ability to designate an individual who has skin cancer as "positive" using the telemedicine platform without nevisense. | End of the study (4 weeks) |
| Sensitivity of Telemedicine Evaluation in Diagnosing Skin Cancer: With Nevisense |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Polsky, MD, PhD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Health | New York | New York | 10016 | United States |
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
The investigator who proposed to use the data.Upon reasonable request. Requests should be directed to David.Polsky@nyulangone.org To gain access, data requestors will need to sign a data access agreement.
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants With Skin Lesions | Participants who have up to 3 concerning skin lesions will be evaluated by both an in-person dermatologist and a team of three teledermatologists(board-certified dermatologists). The teledermatoogy team will deliver a consensus recommendation. If either the in-person dermatologist or teledermatologists are concerned that the skin spot(s) may be a skin cancer, a biopsy will be recommended and can be performed at no charge. Or if both agree that the spot(s) are not concerning for skin cancer, no biopsy will be needed. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants With Skin Lesions | Participants who have up to 3 concerning skin lesions will be evaluated by both an in-person dermatologist and a team of three teledermatologists(board-certified dermatologists). The teledermatoogy team will deliver a consensus recommendation. If either the in-person dermatologist or teledermatologists are concerned that the skin spot(s) may be a skin cancer, a biopsy will be recommended and can be performed at no charge. Or if both agree that the spot(s) are not concerning for skin cancer, no biopsy will be needed. |
| 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 | Median |
| 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 | Accuracy of Skin Cancer Diagnosis: In-Person Assessment | To compare the accuracy of skin cancer diagnoses between in-person recommendation and the telemedicine (tele) recommendation, the number of "positive" evaluations (i.e. recommended for biopsy) that were truly skin cancer plus the number of "negative" evaluations (i.e. not recommended for biopsy) that were truly non-cancerous divided by the total number of skin lesions evaluated is calculated. | Posted | Number | 95% Confidence Interval | percentage of skin lesions | End of the study (4 weeks) | skin lesions | skin lesions |
|
4 months
Non-systematic - patient self-report
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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 | Participants With Skin Lesions | Participants who have up to 3 concerning skin lesions will be evaluated by both an in-person dermatologist and a team of three teledermatologists(board-certified dermatologists). The teledermatoogy team will deliver a consensus recommendation. If either the in-person dermatologist or teledermatologists are concerned that the skin spot(s) may be a skin cancer, a biopsy will be recommended and can be performed at no charge. Or if both agree that the spot(s) are not concerning for skin cancer, no biopsy will be needed. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Minor skin infection | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Polsky, MD, PhD | NYU Langone Health | 212-263-9087 | David.Polsky@nyulangone.org |
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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 | Sep 13, 2022 | Feb 29, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012878 | Skin Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Dermlite Cam | Device | Dermlite Cam is a digital camera that captures images of the skin under cross-polarized and non-polarized light and is 510(k) exempt. The DermLite Cam device appears as a single piece camera with a charging cable and USB computer cable. As part of the camera unit, an extensor arm exists to allow for the capture of standardized clinical images. The DermLite Cam will be used to acquire 3 images of <5 seconds per lesion (one clinical, one polarized dermoscopic, and one non-polarized dermoscopic). NOTE - for the purposes of this study, teledermatology images (dermoscopic and clinical - at approximately 6 inches, 12 inches, and 18 inches) were taken using the Barco Demetra after technical issues arose that prohibited the continued use of the Dermlite Cam. |
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| Skin biopsy | Procedure | A skin biopsy is a small procedure that removes a sample of skin from the surface of the body. The method utilized will be either a shave or punch technique. The maximum size of a punch biopsy will be 6mm and these wounds are generally closed with no more than 2-3 sutures. A skin biopsy takes <15 minutes including preparation time, administration of intradermal anesthesia using lidocaine 1% with epinephrine 1:100,000, removal of the skin sample, achievement of hemostasis, dressing the wound, and providing instructions for home care. Samples will be placed formalin for routine processing. |
|
| Barco Demetra | Device | Barco Demetra is a non-invasive skin imaging system, which acquires multispectral and white light dermoscopic images and clinical photographs of the skin which can then be stored, retrieved, displayed, and reviewed by medical practitioners. The Barco Demetra received 510(k) Premarket approval (K192829). The system involves a hardware imaging device and a stand-alone software application. The hardware device is a portable, battery-powered medical device for acquiring and visualizing images of the skin and uploads all images to cloud storage. The software application is cloud software with an associated web application; it can be used to visualize images and related data and can generate consultation reports. For the purposes of this study, teledermatology images (dermoscopic and clinical - at approximately 6 inches, 12 inches, and 18 inches) were taken using the Barco Demetra after technical issues arose that prohibited the continued use of the Dermlite Cam. |
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Assessment of the dermatologist's ability to designate an individual who has skin cancer as "positive" using the telemedicine platform with nevisense. |
| End of the study (4 weeks) |
| Sensitivity of In-Person Evaluation in Diagnosing Skin Cancer | Assessment of the dermatologist's ability to designate an individual who has skin cancer as "positive" during in-person evaluations. | End of the study (4 weeks) |
| Specificity of Telemedicine Evaluation in Diagnosing Skin Cancer: Without Nevisense | Assessment of the dermatologist's ability to designate an individual who does not have skin cancer as "negative" using the telemedicine platform without nevisense. | End of the study (4 weeks) |
| Specificity of Telemedicine Evaluation in Diagnosing Skin Cancer: With Nevisense | Assessment of the dermatologist's ability to designate an individual who does not have skin cancer as "negative" using the telemedicine platform with Nevisense. | End of the study (4 weeks) |
| Specificity of In-Person Evaluation in Diagnosing Skin Cancer | Assessment of the dermatologist's ability to designate an individual who does not have skin cancer as "negative" during in-person evaluations. | End of the study (4 weeks) |
| False-Positive Rate of Telemedicine Evaluation: Without Nevisense | The number of false-positives (i.e., diagnosing a patient with skin cancer when no skin cancer is present) out of the total number of telemedicine evaluations without Nevisense. | End of the study (4 weeks) |
| False-Positive Rate of Telemedicine Evaluation: With Nevisense | The number of false-positives (i.e., diagnosing a patient with skin cancer when no skin cancer is present) out of the total number of telemedicine evaluations with Nevisense. | End of the study (4 weeks) |
| False-Positive Rate of In-Person Evaluation | The number of false-positives (i.e., diagnosing a patient with skin cancer when no skin cancer is present) out of the total number of in-person evaluations. | End of the study (4 weeks) |
| False-Negative Rate of Telemedicine Evaluation: Without Nevisense | The number of false-negatives (i.e., indicating a patient does not have skin cancer when skin cancer is present) out of the total number of telemedicine evaluations without Nevisense. | End of the study (4 weeks) |
| False-Negative Rate of Telemedicine Evaluation: With Nevisense | The number of false-negatives (i.e., indicating a patient does not have skin cancer when skin cancer is present) out of the total number of telemedicine evaluations with Nevisense. | End of the study (4 weeks) |
| False-Negative Rate of In-Person Evaluation | The number of false-negatives (i.e., indicating a patient does not have skin cancer when skin cancer is present) out of the total number of in-person evaluations. | End of the study (4 weeks) |
| Positive Predictive Value of Telemedicine Evaluation: Without Nevisense | The probability that a patient with a positive (abnormal) test result via telemedicine evaluation without Nevisense actually has skin cancer. | End of the study (4 weeks) |
| Positive Predictive Value of Telemedicine Evaluation: With Nevisense | The probability that a patient with a positive (abnormal) test result via telemedicine evaluation with Nevisense actually has skin cancer. | End of the study (4 weeks) |
| Positive Predictive Value of In-Person Evaluation | The probability that a patient with a positive (abnormal) test result via in-person evaluation actually has skin cancer. | End of the study (4 weeks) |
| Negative Predictive Value of Telemedicine Evaluation: Without Nevisense | The probability that a person with a negative (normal) test result via telemedicine evaluation without Nevisense is truly free of disease. | End of the study (4 weeks) |
| Negative Predictive Value of Telemedicine Evaluation: With Nevisense | The probability that a person with a negative (normal) test result via telemedicine evaluation with Nevisense is truly free of disease. | End of the study (4 weeks) |
| Negative Predictive Value of In-Person Evaluation | The probability that a person with a negative (normal) test result via in-person evaluation is truly free of disease. | End of the study (4 weeks) |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Primary | Accuracy of Skin Cancer Diagnosis: Telemedicine Without Nevisense | To compare the accuracy of skin cancer diagnoses between in-person recommendation and the telemedicine (tele) recommendation, the number of "positive" evaluations (i.e. recommended for biopsy) that were truly skin cancer plus the number of "negative" evaluations (i.e. not recommended for biopsy) that were truly non-cancerous divided by the total number of skin lesions evaluated is calculated. | Posted | Number | 95% Confidence Interval | percentage of skin lesions | End of the study (4 weeks) | skin lesions | skin lesions |
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| Primary | Accuracy of Skin Cancer Diagnosis: Telemedicine With Nevisense | To compare the accuracy of skin cancer diagnoses between in-person recommendation and the telemedicine (tele) recommendation, the number of "positive" evaluations (i.e. recommended for biopsy) that were truly skin cancer plus the number of "negative" evaluations (i.e. not recommended for biopsy) that were truly non-cancerous divided by the total number of skin lesions evaluated is calculated. | Posted | Number | 95% Confidence Interval | percentage of skin lesions | End of the study (4 weeks) | skin lesions | skin lesions |
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| Secondary | Sensitivity of Telemedicine Evaluation in Diagnosing Skin Cancer: Without Nevisense | Assessment of the dermatologist's ability to designate an individual who has skin cancer as "positive" using the telemedicine platform without nevisense. | Posted | Number | 95% Confidence Interval | percentage of skin lesions | End of the study (4 weeks) | Skin lesions | Skin lesions |
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| Secondary | Sensitivity of Telemedicine Evaluation in Diagnosing Skin Cancer: With Nevisense | Assessment of the dermatologist's ability to designate an individual who has skin cancer as "positive" using the telemedicine platform with nevisense. | Posted | Number | 95% Confidence Interval | percentage of skin lesions | End of the study (4 weeks) | Skin lesions | Skin lesions |
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| Secondary | Sensitivity of In-Person Evaluation in Diagnosing Skin Cancer | Assessment of the dermatologist's ability to designate an individual who has skin cancer as "positive" during in-person evaluations. | Posted | Number | 95% Confidence Interval | percentage of skin lesions | End of the study (4 weeks) | Skin lesions | Skin lesions |
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| Secondary | Specificity of Telemedicine Evaluation in Diagnosing Skin Cancer: Without Nevisense | Assessment of the dermatologist's ability to designate an individual who does not have skin cancer as "negative" using the telemedicine platform without nevisense. | Posted | Number | 95% Confidence Interval | percentage of skin lesions | End of the study (4 weeks) | Skin lesions | Skin lesions |
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| Secondary | Specificity of Telemedicine Evaluation in Diagnosing Skin Cancer: With Nevisense | Assessment of the dermatologist's ability to designate an individual who does not have skin cancer as "negative" using the telemedicine platform with Nevisense. | Posted | Number | 95% Confidence Interval | percentage of skin lesions | End of the study (4 weeks) | Skin lesions | Skin lesions |
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| Secondary | Specificity of In-Person Evaluation in Diagnosing Skin Cancer | Assessment of the dermatologist's ability to designate an individual who does not have skin cancer as "negative" during in-person evaluations. | Posted | Number | 95% Confidence Interval | percentage of skin lesions | End of the study (4 weeks) | Skin lesions | Skin lesions |
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| Secondary | False-Positive Rate of Telemedicine Evaluation: Without Nevisense | The number of false-positives (i.e., diagnosing a patient with skin cancer when no skin cancer is present) out of the total number of telemedicine evaluations without Nevisense. | Posted | Number | 95% Confidence Interval | percentage of skin lesions | End of the study (4 weeks) | Skin lesions | Skin lesions |
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| Secondary | False-Positive Rate of Telemedicine Evaluation: With Nevisense | The number of false-positives (i.e., diagnosing a patient with skin cancer when no skin cancer is present) out of the total number of telemedicine evaluations with Nevisense. | Posted | Number | 95% Confidence Interval | percentage of skin lesions | End of the study (4 weeks) | Skin lesions | Skin lesions |
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| Secondary | False-Positive Rate of In-Person Evaluation | The number of false-positives (i.e., diagnosing a patient with skin cancer when no skin cancer is present) out of the total number of in-person evaluations. | Posted | Number | 95% Confidence Interval | percentage of skin lesions | End of the study (4 weeks) | Skin lesions | Skin lesions |
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| Secondary | False-Negative Rate of Telemedicine Evaluation: Without Nevisense | The number of false-negatives (i.e., indicating a patient does not have skin cancer when skin cancer is present) out of the total number of telemedicine evaluations without Nevisense. | Posted | Number | 95% Confidence Interval | percentage of skin lesions | End of the study (4 weeks) | Skin lesions | Skin lesions |
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| Secondary | False-Negative Rate of Telemedicine Evaluation: With Nevisense | The number of false-negatives (i.e., indicating a patient does not have skin cancer when skin cancer is present) out of the total number of telemedicine evaluations with Nevisense. | Posted | Number | 95% Confidence Interval | percentage of skin lesions | End of the study (4 weeks) | Skin lesions | Skin lesions |
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| Secondary | False-Negative Rate of In-Person Evaluation | The number of false-negatives (i.e., indicating a patient does not have skin cancer when skin cancer is present) out of the total number of in-person evaluations. | Posted | Number | 95% Confidence Interval | percentage of skin lesions | End of the study (4 weeks) | Skin lesions | Skin lesions |
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| Secondary | Positive Predictive Value of Telemedicine Evaluation: Without Nevisense | The probability that a patient with a positive (abnormal) test result via telemedicine evaluation without Nevisense actually has skin cancer. | Posted | Number | 95% Confidence Interval | percentage of skin lesions | End of the study (4 weeks) | Skin lesions | Skin lesions |
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| Secondary | Positive Predictive Value of Telemedicine Evaluation: With Nevisense | The probability that a patient with a positive (abnormal) test result via telemedicine evaluation with Nevisense actually has skin cancer. | Posted | Number | 95% Confidence Interval | percentage of skin lesions | End of the study (4 weeks) | Skin lesions | Skin lesions |
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| Secondary | Positive Predictive Value of In-Person Evaluation | The probability that a patient with a positive (abnormal) test result via in-person evaluation actually has skin cancer. | Posted | Number | 95% Confidence Interval | percentage of skin lesions | End of the study (4 weeks) | Skin lesions | Skin lesions |
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| Secondary | Negative Predictive Value of Telemedicine Evaluation: Without Nevisense | The probability that a person with a negative (normal) test result via telemedicine evaluation without Nevisense is truly free of disease. | Posted | Number | 95% Confidence Interval | percentage of skin lesions | End of the study (4 weeks) | Skin lesions | Skin lesions |
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| Secondary | Negative Predictive Value of Telemedicine Evaluation: With Nevisense | The probability that a person with a negative (normal) test result via telemedicine evaluation with Nevisense is truly free of disease. | Posted | Number | 95% Confidence Interval | percentage of skin lesions | End of the study (4 weeks) | Skin lesions | Skin lesions |
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| Secondary | Negative Predictive Value of In-Person Evaluation | The probability that a person with a negative (normal) test result via in-person evaluation is truly free of disease. | Posted | Number | 95% Confidence Interval | percentage of skin lesions | End of the study (4 weeks) | Skin lesions | Skin lesions |
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