DERMAPOL: Medical Device Based on Polarized Light for Cutaneous Lesions Visualization

Sponsor
University Hospital, Strasbourg, France (Other)
Overall Status
Recruiting
CT.gov ID
NCT03796871
Collaborator
(none)
200
1
1
54.9
3.6

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
  • Device: Dermapol
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Interest of a New Medical Device for the Visualization of Cutaneous Lesions Based on Polarized Light
Actual Study Start Date :
Jun 19, 2019
Anticipated Primary Completion Date :
Jan 14, 2024
Anticipated Study Completion Date :
Jan 14, 2024

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Physico-optical description of the lesions [Before biopsy]

    Physico-optical description of the cutaneous lesions by the medical device

  2. 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

  3. Proportion of semiological characteristics properly identified [Before biopsy]

    Proportion of semiological characteristics properly identified by the medical device for all lesions

  4. 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

  5. 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

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
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.
Responsible Party:
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT03796871
Other Study ID Numbers:
  • 6798
First Posted:
Jan 8, 2019
Last Update Posted:
Aug 19, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Aug 19, 2022