Medical Device Based on Polarized Light for Cutaneous Lesions Visualization

Skin Lesion Clinical Trial

— DERMAPOL  

Official title:

Interest of a New Medical Device for the Visualization of Cutaneous Lesions Based on Polarized Light

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03796871
• Other study ID #: 6798
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Skin Lesion

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