Early Feasibility Study of the "Easy Light" Fluorecence I... | NCT05004623

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

NCT05004623

Sponsor

Professor Fernando Figueira Integral Medicine Institute

Status

Completed

Last Update Posted

Aug 13, 2021Actual

Enrollment

5Actual

Phase

Not Applicable

Conditions

Uterine Cervical Neoplasms
Uterine Neoplasms

Interventions

Sentinel Lymph Node Biopsy

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 26, 2021Actual

Primary Completion Date

Jul 27, 2021Actual

Completion Date

Aug 6, 2021Actual

First Submitted Date

Jun 16, 2021

First Submission Date that Met QC Criteria

Aug 9, 2021

First Posted Date

Aug 13, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 9, 2021

Last Update Posted Date

Aug 13, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Thales Paulo Batista, Consulting, Professor Fernando Figueira Integral Medicine InstitutePrincipal Investigator

Lead Sponsor

Professor Fernando Figueira Integral Medicine InstituteOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

5Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Sentinel Lymph Node Biopsy	Other	Sentinel lymph node biopsy by indocyanine green (ICG) fluorescent dye technique, using a prototype of the Easy Light device. Lymph node dissection in each hemipelvis should be performed as standard if no sentinel lymph node is detected. Decision of proceeding with complementary lymph node dissection after sentinel lymph node detection is a surgeon decision, according to his/her usual practice.	Device: Sentinel Lymph Node Biopsy

Interventions

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

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Thales P Batita, PhD	IMIP, Department of Surgery/Oncology	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
IMIP - Instituo de Medicina Integral Professor Fernando Figueira		Recife	Pernambuco	50070-550	Brazil

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002583	Uterine Cervical Neoplasms
D014594	Uterine Neoplasms

Ancestor Terms

ID	Term
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D021701	Sentinel Lymph Node Biopsy

Ancestor Terms

ID	Term
D001706	Biopsy
D003581	Cytodiagnosis
D003584	Cytological Techniques
D019411	Clinical Laboratory Techniques

Browse Leaves

Not provided

Browse Branches

Not provided