Fluorescent Approach for Refined Endoscopic Marking With Clip Localization and Identification Procedure (FLARECLIP)

November 17, 2025 updated by: Seoul National University Hospital

Efficacy and Safety of Fluorescent Surgical Marker Clip for Tumor Localization in Laparoscopic Colorectal Surgery for Colorectal Cancer Patients : Multi-center, Randomized, Single-blind, Prospective, Non-Inferiority Trial

  • Title of the Study Testing a Fluorescent Surgical Marker Clip for Tumor Localization in Minimally Invasive Colorectal Surgery
  • Purpose of the Study This study aims to determine if a fluorescent surgical marker clip can accurately and safely localize tumor locations in the colon during minimally invasive colorectal surgery. The study will compare the effectiveness of this clip to the current method using a dye called Indocyanine Green (ICG).

The main questions the investigators aim to address are:

Can the clip safely and effectively localize tumor sites compared to ICG dye? What side effects or medical issues might arise with the use of the clip?

-Study Design Assignment

Participants will be randomly assigned to one of two groups:

The clip group: A fluorescent clip will be placed near the tumor. The dye group: ICG dye will be injected near the tumor.

Procedures Participants will undergo a colonoscopy to mark the tumor location before surgery using either the fluorescent clip or ICG dye.

  • Follow-Up Participants will attend follow-up visits after surgery to monitor for any side effects or complications.
  • Eligibility Inclusion Criteria

Participants may qualify if:

They are 19 years or older. They are scheduled for minimally invasive colorectal surgery for a tumor or suspected tumor.

Exclusion Criteria

Participants cannot enroll if:

They have certain medical conditions, such as blood clotting disorders or allergies to metals or iodine.

They are pregnant or breastfeeding.

-Participant Role By participating, individuals will contribute to advancing research aimed at improving methods for tumor localization during surgery, potentially leading to enhanced surgical outcomes in the future.

For questions or concerns, participants are encouraged to contact the investigators or the research team.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

110

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • South Korea
      • Seoul, South Korea, 03080
        • Seoul National University Hospital
      • Seoul, South Korea, 07061
        • Seoul Boramae Medical Center
    • Gyeonggi-do
      • Goyang-si, Gyeonggi-do, South Korea, 10408
        • National Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Aged 19years or more
  • With colonic neoplasm planning minimally invasive surgery
  • Need localization of lesion before surgery

Exclusion Criteria:

  • Planned total proctocolectomy
  • Contraindication of colonoscopy
  • On pregnancy or breast-feeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Clip group
Patients who are underwent localization of colon lesion with fluorescent clip
Procedure: Endoscopic Clipping
localization of colon lesion with fluorescent clip
Active Comparator: ICG group
Patients who are underwent localization of colon lesion with ICG(indocyanine green) through tattooing method
Procedure: ICG injection
localization of colon lesion with ICG(indocyanine green) through endoscopic tattooing
Other Names:
  • ICG tattooing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success rate of localization
Time Frame: In operation

Accuracy of Identifying the Exact Tumor Location

Experimental Group: Considered successful when the tumor can be observed through the applied clips using fluorescence imaging.

Control Group: Considered successful when the ICG-tattooed tumor can be observed.
In operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reconfirmation Rate via Intraoperative Colonoscopy (%)
Time Frame: In operation
The proportion of cases where intraoperative colonoscopy was performed.
In operation
Total Operation Time (minutes)
Time Frame: From start of operation to end of operation.
The time from skin incision to skin closure.
From start of operation to end of operation.
Time Required for Endoscopic Marking Procedure (minutes)
Time Frame: From identifying of tumor in colonoscopy to completing the clipping or injection of ICG
The time from identifying the tumor to completing the attachment of all required clips for marking the tumor or completing the injection of ICG.
From identifying of tumor in colonoscopy to completing the clipping or injection of ICG
Longitudinal Length of ICG Spread in the Control Group (mm)
Time Frame: After resection of colon, in operation
In ICG group, measure the length of tattooed area using a disposable paper ruler on the serosa side of colon.
After resection of colon, in operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Ji Won Park, M.D., Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 10, 2024

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

November 25, 2024

First Submitted That Met QC Criteria

November 27, 2024

First Posted (Actual)

December 3, 2024

Study Record Updates

Last Update Posted (Actual)

November 19, 2025

Last Update Submitted That Met QC Criteria

November 17, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KSC-CRC-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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