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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03079232
Other study ID # 1608015
Secondary ID 2016-A00319-42
Status Completed
Phase N/A
First received
Last updated
Start date March 28, 2017
Est. completion date August 1, 2018

Study information

Verified date November 2018
Source Centre Hospitalier Universitaire de Saint Etienne
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

OCTAV is a medical device class I, not CE marked, based on a new technique for high-resolution imager (cell) internal microstructures of all types of biological tissues in vivo or ex vivo, to a depth of penetration 800 .mu.m. It allows to explore the epidermis, the dermo-epidermal junction and middle dermis in a totally non-invasive (direct contact with the tissue without sampling).


Description:

At the coming of the patient in Dermatology for resection / biopsy of the tumor (usual practice), for the study, an image of the tumor will be performed with the OCTAV device (about 5 minutes) for the study. Then, according to usual practice, resection / biopsy will be performed.

This study aims to validate the clinical relevance of this device to characterize the 3 main skin cancers and to obtain the necessary data for the implementation of future clinical trials.


Recruitment information / eligibility

Status Completed
Enrollment 122
Est. completion date August 1, 2018
Est. primary completion date August 1, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility FOR PATIENT

Inclusion Criteria:

- Patient with a cutaneous lesion suspicious for melanoma, basal cell carcinoma, squamous cell carcinoma, requiring a surgical excision

- Consent form signed

- Major patient

Exclusion Criteria:

- Allergy or intolerance to immersion oil (used for microscopy)

- If female, pregnant or breast-feeding

- Patient unable to stand still for 60 seconds

- Skin lesions located near patient eyes (<3 cm)

FOR CONTROL GROUP

Inclusion Criteria:

- Aged between 18 to 40 years

- Consent form signed

- Patient of the dermatology department with non-pathological forearm skin

Exclusion Criteria:

- Allergy or intolerance to immersion oil (used for microscopy)

- If female, pregnant or breast-feeding

- Patient unable to stand still for 60 seconds

Study Design


Related Conditions & MeSH terms


Intervention

Device:
OCTAV Patient
In vivo skin imaging performed by placing the tip of the OCTAV device directly in slight contact with the skin of the patient.
OCTAV Control group
In vivo skin imaging performed by placing the tip of the OCTAV device directly in slight contact with the skin of the patient.

Locations

Country Name City State
France Chu de Saint Etienne Saint Etienne

Sponsors (2)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Saint Etienne DAMAE Médical

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Sensitivity Sensitivity measures the proportion of positive skin cancers (according to the OCTAV device) that are correctly identified as such (according to gold standard : histology) Day 1
Primary Specificity Specificity measures the proportion of negative skin cancers (according to the OCTAV device) that are correctly identified as such (according to gold standard : histology) Day 1
Secondary Measure of the thickness of the different skin layers (mm) Only for the non skin cancer group. Theses measures will identify the different skin layers (Epidermis, Dermis, Subcutaneous tissue, Cross-section) Day 1
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