Medical Device Based on Polarized Light for Cutaneous Lesions Visualization (DERMAPOL)

University Hospital, Strasbourg, France

Status: Terminated

Conditions: Skin Lesion

Treatments: Device: Dermapol

Study type: Interventional

Funder types: Other

Identifiers

NCT03796871

6798

Details and patient eligibility

About

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.

Enrollment: 38 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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38 participants in 1 patient group

Dermapol

Experimental group

Description:

Use of the experimental medical device

Treatment:

Device: Dermapol