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The objective of this study is to evaluate the sensitivity of the DermaSensor device and Investigators when used on skin lesions concerning for melanoma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clinical assessment only | No Intervention | Lesions assessed as clinically suspicious by primary care investigator who make diagnostic and management decision to biopsy without ESS device output | |
| Clinical assessment with device output | Experimental | Lesions assessed as clinically suspicious by primary care investigator who make diagnostic and management decision to biopsy with ESS device output |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Scan with elastic scattering spectroscopy device to assess risk of malignancy | Device | Elastic scattering spectroscopy device uses a spectrum of light reflectance to compare suspicious lesion signature to that of previously scanned lesions with known benign or malignant pathology |
| Measure | Description | Time Frame |
|---|---|---|
| Device Sensitivity | 39 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Justin Frazier, MS | Contact | 508-776-0044 | justin.frazier@dermasensor.com |
| Name | Affiliation | Role |
|---|---|---|
| Gary Slatko, MD, MBA | DermaSensor, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Velocity | Recruiting | New Smyrna Beach | Florida | 32168 | United States |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D011877 | Radionuclide Imaging |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D003947 | Diagnostic Techniques, Radioisotope |
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Enrolled lesions are assessed without and then with the device result as basis for study investigator decision to biopsy or monitor a potentially malignant lesion.
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Investigator unaided (i.e., blinded/masked) assessment followed by aided assessment of each lesion's malignancy risk.
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| West Clinical Research | Recruiting | Morehead City | North Carolina | 28557 | United States |
|
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |