Early Feasibility Study of the "Easy Light" Fluorecence Imaging System

Uterine Cervical Neoplasms Clinical Trial

Official title: Early Feasibility Study of an Open-Field Handheld Wireless Fluorecence Imaging System for Detection of Sentinel Lymph Nodes in Women With Cervical and Uterine Cancers

Status Completed

Clinical Trial Summary

This is an early feasibility study to evaluate the device functionality of an open-field handheld wireless fluorecence imaging system for detection of sentinel lymph nodes in women with cervical and uterine cancers who underwent open surgery.

Clinical Trial Description

This study was designed to clinically evaluate the functionality of an prototype of our near-infrared fluorescence device named Easy Light. In brief, this device is an open-field handheld wireless fluorecence imaging system that allows real-time visualization of fluorescent dyes such as indocyanine green (ICG) using smartphones and tablets. The handheld is a rechargeable device responsible for excitation of the operative field with infra-red lighting and for capturing the fluorescence emitted by de fluorescent dye to be visualized via wi-fi in the smartphones and tablets using a pre-installed application software. Following the standards of near-infrared fluorescence for detection of sentinel lymph nodes in gynecological malignancies, the hypothesis was the identification of sentinel lymph nodes after lymphatic mapping by interstitial indocyanine green injection in the cervix was feasible with the use of our device named Easy Light. ;

Related Conditions & MeSH terms

• Neoplasms
• Uterine Cervical Neoplasms
• Uterine Neoplasms

• NCT number: NCT05004623
• Study type: Interventional
• Source: Professor Fernando Figueira Integral Medicine Institute
• Status: Completed
• Phase: N/A
• Start date: May 26, 2021
• Completion date: August 6, 2021