DERMAPOL: Medical Device Based on Polarized Light for Cutaneous Lesions Visualization
Study Details
Study Description
Brief Summary
Skin cancers represent a real public health issue. The diagnosis of pre-cancerous lesions thus is a priority. The diagnosis gold standard is based on the combination of clinical and histopathological examinations. Nevertheless, the clinical examination is not sufficiently effective, meaning that a biopsy has to be done for each suspected lesion. In order to avoid unnecessary biopsy excisions, a new medical device (DERMAPOL) was designed to help dermatologists in diagnosing skin lesions.
This medical device combined with its software is a strong and ergonomic spectro-polarimetric imager instrument. It can realize images of the superficial cutaneous tissues and subcutaneous tissues close to the surface by exploiting polarized light properties.
This first clinical trial aims to demonstrate that this medical device is able to segment effectively healthy and tumor tissues and that it can correlate main semiological elements (identified thanks to the clinical and histopathological examinations) to the physico-optical characteristics obtained on the images of the medical device.
Condition or Disease | Intervention/Treatment | Phase |
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N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Dermapol Use of the experimental medical device |
Device: Dermapol
Use of the experimental medical device before lesion excision : skin lesion lighting (4 wavelengths) for less than 1 minute and image recording
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Outcome Measures
Primary Outcome Measures
- Proportion of lesions with semiological characteristics [Before biopsy]
Proportion of lesions for which at least one semiological characteristic (detected by the combination of visual and histopathological examinations) was identified by the medical device thanks to physico-optical properties
Secondary Outcome Measures
- Physico-optical description of the lesions [Before biopsy]
Physico-optical description of the cutaneous lesions by the medical device
- Number of different semiological characteristics [Before biopsy]
Number of different semiological characteristics visualized by the medical device and by the combination of clinical and histopathological examinations for each image processing
- Proportion of semiological characteristics properly identified [Before biopsy]
Proportion of semiological characteristics properly identified by the medical device for all lesions
- Specificity, sensitivity and predictive values [Before biopsy]
Specificity, sensitivity, true positive rate, true negative rate, false positive rate, false negative rate of the medical device, for each semiological characteristic identified by the combination of the clinical and histopathological examinations
- Cases proportion for which the same semiological characteristics list was found between the medical device and the combination of clinical and histopathological diagnosis [Before biopsy]
Proportion of cases with same semiological characteristics list
Eligibility Criteria
Criteria
Inclusion Criteria:
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adult patient with a skin tumor (benign or cancerous) which has to be excised and analysed according to histopathological examination
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skin lesion belonging to one of these groups (diagnosed by clinical examination):
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cutaneous cyst
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seborrhoeic keratosis
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cutaneous carcinoma
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naevus
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melanoma
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actinic keratosis and cutaneous horn
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other skin tumors
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skin lesion size equal to or less than 5 cm
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signed written consent form
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patient affiliated to a social insurance
Exclusion Criteria:
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skin lesion size strictly over than 5 cm
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eyelid lesion
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aluminium, POM (polyoxymethylene) or organic glass allergy
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known pregnancy, breast-feeding
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Hôpitaux Universitaires de Strasbourg | Strasbourg | France | 67091 |
Sponsors and Collaborators
- University Hospital, Strasbourg, France
Investigators
- Principal Investigator: Bernard CRIBIER, MD, Hôpitaux Universitaires de Strasbourg
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 6798