Colon CancerPhase 2FLARECLIPNCT06714292
Fluorescent Approach for Refined Endoscopic Marking With Clip Localization and Identification Procedure
A Phase 2 study testing Endoscopic Clipping and ICG injection in people with Colon Cancer, run by Seoul National University Hospital at 3 sites in South Korea.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Colon Cancer
- What is being tested?
- Endoscopic Clipping and ICG injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 3 sitesSouth Korea
- Study dates
- 10 Dec 2024to 19 Nov 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 19years or more
- With colonic neoplasm planning minimally invasive surgery
- Need localization of lesion before surgery
Who cannot join
- Planned total proctocolectomy
- Contraindication of colonoscopy
- On pregnancy or breast-feeding
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites
National Cancer Center
Goyang-si, Gyeonggi-do, 10408
Seoul National University Hospital
Seoul, 03080
Seoul Boramae Medical Center
Seoul, 07061
About this study
Official 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
- 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:
Read more
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.
- Conditions
- Colon Cancer
- Being tested
- Endoscopic Clipping, ICG injection
- Keywords
- tattooing, localization, colon cancer
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic ClippingProcedure or surgery
localization of colon lesion with fluorescent clip
ICG injectionProcedure or surgery
Also called ICG tattooing
localization of colon lesion with ICG(indocyanine green) through endoscopic tattooing
| Study group | Role | What they receive |
|---|---|---|
| Clip group | Experimental | Patients who are underwent localization of colon lesion with fluorescent clip Receives: Procedure: Endoscopic Clipping |
| ICG group | Active comparator | Patients who are underwent localization of colon lesion with ICG(indocyanine green) through tattooing method Receives: Procedure: ICG injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of localization
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.
Measured: In operation
Secondary outcomes (4)
Reconfirmation Rate via Intraoperative Colonoscopy (%)
The proportion of cases where intraoperative colonoscopy was performed.
Measured: In operation
Total Operation Time (minutes)
The time from skin incision to skin closure.
Measured: From start of operation to end of operation.
Time Required for Endoscopic Marking Procedure (minutes)
The time from identifying the tumor to completing the attachment of all required clips for marking the tumor or completing the injection of ICG.
Measured: From identifying of tumor in colonoscopy to completing the clipping or injection of ICG
Longitudinal Length of ICG Spread in the Control Group (mm)
In ICG group, measure the length of tattooed area using a disposable paper ruler on the serosa side of colon.
Measured: After resection of colon, in operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2024
- Study start10 Dec 2024
- Primary completion23 Oct 2025
- Study completion19 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ji Won Park, M.D., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06714292
- Sponsor's protocol ID
- KSC-CRC-01
- Acronym
- FLARECLIP
- Status last verified
- Jan 2026
- First submitted
- 25 Nov 2024
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06714292
- Acronym / sponsor ID
- FLARECLIP / KSC-CRC-01
- Conditions
- Colon Cancer
- Keywords
- tattooing, localization, colon cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 10 Dec 2024 (actual)
- Primary completion
- 23 Oct 2025 (actual)
- Study completion
- 19 Nov 2025 (actual)
- First posted
- 3 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clip group | Experimental | Procedure: Endoscopic ClippingPatients who are underwent localization of colon lesion with fluorescent clip |
| ICG group | Active comparator | Procedure: ICG injectionPatients who are underwent localization of colon lesion with ICG(indocyanine green) through tattooing method |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 19years or more
- With colonic neoplasm planning minimally invasive surgery
- Need localization of lesion before surgery
Key exclusion criteria (3 listed)
- Planned total proctocolectomy
- Contraindication of colonoscopy
- On pregnancy or breast-feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endoscopic Clippinglocalization of colon lesion with fluorescent clip | Procedure or surgery | Clip group |
| ICG injectionAlso: ICG tattooinglocalization of colon lesion with ICG(indocyanine green) through endoscopic tattooing | Procedure or surgery | ICG group |
Primary outcome
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.
4 secondary outcomes
Reconfirmation Rate via Intraoperative Colonoscopy (%)
Time frame: In operation
Total Operation Time (minutes)
Time frame: 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
Longitudinal Length of ICG Spread in the Control Group (mm)
Time frame: After resection of colon, in operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ji Won Park, M.D. principal investigator
Seoul National University Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Endoscopic Clipping and ICG injection in people with Colon Cancer, run by Seoul National University Hospital at 3 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate of localization (time frame: In operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.