NCT06714292CompletedPhase 2
Fluorescent Approach for Refined Endoscopic Marking With Clip Localization and Identification Procedure
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
Source: ClinicalTrials.gov · Last updated 5 Aug 2026
Brief summary (registry, in English)
* 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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 110 (actual)
- First submitted
- 25 Nov 2024
- Start date
- 10 Dec 2024
- Primary completion date
- 23 Oct 2025
- Lead sponsor
- Seoul National University Hospital
- Diseases
- Colorectal cancer
- NCT number
- NCT06714292
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 110
- From 10 Dec 2024 to the primary completion date, 23 Oct 2025
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Planned total proctocolectomy
- Contraindication of colonoscopy
- On pregnancy or breast-feeding
Who the study is looking for
- Aged 19years or more
- With colonic neoplasm planning minimally invasive surgery
- Need localization of lesion before surgery
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Cancer Center Coordinator of this site? Confirm its status | Goyang-si | South Korea | Unknown status |
| Seoul Boramae Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.