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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03796871
Other study ID # 6798
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 19, 2019
Est. completion date January 14, 2024

Study information

Verified date August 2023
Source University Hospital, Strasbourg, France
Contact Nicolas MEYER, MD
Phone 3 88 11 63 32
Email nicolas.meyer@chru-strasbourg.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date January 14, 2024
Est. primary completion date January 14, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - adult patient with a skin tumor (benign or cancerous) which has to be excised and analysed according to histopathological examination - skin lesion belonging to one of these groups (diagnosed by clinical examination): - cutaneous cyst - seborrhoeic keratosis - cutaneous carcinoma - naevus - melanoma - actinic keratosis and cutaneous horn - other skin tumors - skin lesion size equal to or less than 5 cm - signed written consent form - patient affiliated to a social insurance Exclusion Criteria: - skin lesion size strictly over than 5 cm - eyelid lesion - aluminium, POM (polyoxymethylene) or organic glass allergy - known pregnancy, breast-feeding

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Dermapol
Use of the experimental medical device before lesion excision : skin lesion lighting (4 wavelengths) for less than 1 minute and image recording

Locations

Country Name City State
France Hôpitaux Universitaires de Strasbourg Strasbourg

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Proportion of lesions with semiological characteristics 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 Before biopsy
Secondary Physico-optical description of the lesions Physico-optical description of the cutaneous lesions by the medical device Before biopsy
Secondary Number of different semiological characteristics Number of different semiological characteristics visualized by the medical device and by the combination of clinical and histopathological examinations for each image processing Before biopsy
Secondary Proportion of semiological characteristics properly identified Proportion of semiological characteristics properly identified by the medical device for all lesions Before biopsy
Secondary Specificity, sensitivity and predictive values 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 Before biopsy
Secondary Cases proportion for which the same semiological characteristics list was found between the medical device and the combination of clinical and histopathological diagnosis Proportion of cases with same semiological characteristics list Before biopsy
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