NCT05004623

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

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
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Professor Fernando Figueira Integral Medicine Institute · Academic / Other
• Sex: Female
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Uterine Cervical Neoplasms
• Uterine Neoplasms

Interventions

Type	Name	Description
DEVICE	Sentinel Lymph Node Biopsy	Detection of sentinel lymph nodes by indocyanine green (ICG) fluorescent dye technique, using a prototype of the Easy Light device.

Timeline

• Start date: 2021-05-26
• Primary completion: 2021-07-27
• Completion: 2021-08-06
• First posted: 2021-08-13
• Last updated: 2021-08-13

Locations

1 site across 1 country: Brazil