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NCT Number: NCT06714292

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

* 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

National Cancer Center, Goyang-si, Gyeonggi-do, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endoscopic Clipping

Procedure

localization of colon lesion with fluorescent clip

ICG injection

Procedure

localization of colon lesion with ICG(indocyanine green) through endoscopic tattooing

Other names: ICG tattooing

Primary outcomes

  1. 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.

Secondary outcomes

  1. Reconfirmation Rate via Intraoperative Colonoscopy (%)

    Time frame: In operation

    The proportion of cases where intraoperative colonoscopy was performed.

  2. Total Operation Time (minutes)

    Time frame: From start of operation to end of operation.

    The time from skin incision to skin closure.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Acronym: FLARECLIP

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Dec 3, 2024
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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