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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05004623

Enrollment

Registered

2021-08-13

Start date

2021-05-26

Completion date

2021-08-06

Last updated

2021-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uterine Cervical Neoplasms, Uterine Neoplasms

Keywords

Sentinel Lymph Node Biopsy, Fluorescence, Indocyanine Green

Brief 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.

Interventions

DEVICESentinel Lymph Node Biopsy

Detection of sentinel lymph nodes by indocyanine green (ICG) fluorescent dye technique, using a prototype of the Easy Light device.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DEVICE_FEASIBILITY

Masking

NONE

Intervention model description

This is an early feasibility study.

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 70 Years

Healthy volunteers

Yes

Inclusion criteria

1. Patients with biopsy-proven cervical or uterine cancers; 2. Clinical stage I or II, according to FIGO - The International Federation of Gynecology and Obstetrics; 3. Indication for sentinel lymph node biopsy with or without complementary lymphadenectomy by her medical assistant; 4. Performance status of 0-2; 5. No synchronous malignancies or previous oncological treatments such as radiation or major abdominal surgery; 6. Absence of neuro-psychiatric disorders, apparent or confirmed infections, history of drug allergies, limiting obesity for surgery, and pregnancy or breast feeding; 7. Appropriated cardio-respiratory, hepato-renal and hematological reserves; 8. Signing of the Consent Form.

Exclusion criteria

1\. Perioperative impossibility to inject the fluorescent dye indocyanine green in the cervical region due to any locorregional reason.

Design outcomes

Primary

Measure	Time frame	Description
The ability to detect sentinel lymph nodes.	Intraoperativelly	The ability to detect at least one sentinel lymph node per patient during open surgeries.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026