NCT03079232

First Optical Coherence Microscopy in Dermato-oncology

In Vivo Imaging Innovation : Optical Coherence Microscopy in Dermato-oncology

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 122 (actual)
• Sponsor: Centre Hospitalier Universitaire de Saint Etienne · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Skin Cancer

Interventions

Type	Name	Description
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.
DEVICE	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.

Timeline

• Start date: 2017-03-28
• Primary completion: 2018-08-01
• Completion: 2018-08-01
• First posted: 2017-03-14
• Last updated: 2025-02-10

Locations

1 site across 1 country: France