Medical Device Based on Polarized Light for Cutaneous Lesions Visualization

Not Applicable

Terminated

• Conditions: Skin Lesion
• Interventions: Device: Dermapol

• Registration Number: NCT03796871
• Lead Sponsor: University Hospital, Strasbourg, France

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-12-06
• Study First Submitted QC: 2019-01-07
• Study First Posted: 2019-01-08
• Study Start: 2019-06-19
• Primary Completion: 2024-01-14
• Study Completion: 2024-01-14
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-16
• Last Update Posted: 2024-08-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 38

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dermapol	Dermapol	Use of the experimental medical device

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Physico-optical description of the lesions	Before biopsy	Physico-optical description of the cutaneous lesions by the medical device
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
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

Trial Locations

Locations (1)

Hôpitaux Universitaires de Strasbourg; 🇫🇷 Strasbourg, France