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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05004623
Other study ID # 45814621.5.0000.5201
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 26, 2021
Est. completion date August 6, 2021

Study information

Verified date August 2021
Source Professor Fernando Figueira Integral Medicine Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 5
Est. completion date August 6, 2021
Est. primary completion date July 27, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 70 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Brazil IMIP - Instituo de Medicina Integral Professor Fernando Figueira Recife Pernambuco

Sponsors (1)

Lead Sponsor Collaborator
Professor Fernando Figueira Integral Medicine Institute

Country where clinical trial is conducted

Brazil, 

Outcome

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