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ICG-coated Endoscopic Clip for Tumor Localization

Not Applicable
Completed
Conditions
Colorectal Neoplasms
Interventions
Device: ICG-coated clip
Registration Number
NCT03924349
Lead Sponsor
National Cancer Center, Korea
Brief Summary

The fluorescent clipping method involves endoscopic clipping a fluorescent clip into the colonic lesion site in advance of surgery, and observing the position of the fluorescence through the colonic wall by a light source of a certain wavelength band during surgery.

The purpose of this study is to evaluate the efficacy of the localization of colonic lesions using ICG coated endoscopic clip in laparoscopic colon surgery.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
30
Inclusion Criteria
  • Cases which are deemed necessary to mark the location of the colon lesion before surgery
Exclusion Criteria
  • Preoperative colonoscopy is not possible due to intestinal obstruction
  • If the lesion is located in the rectal area and the lesion can be confirmed by digital rectal exam
  • disagreement with the study

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
ICG clipICG-coated clipThree clips are fixed in three directions (120 degrees apart) at the distal of the lesion (just distal) before surgery
Primary Outcome Measures
NameTimeMethod
Success rate of localizationthrough study completion, an average of 1 year

The rate of Identifying ICG-coated clip during surgery

Secondary Outcome Measures
NameTimeMethod
Number of Participants with Complicationthrough study completion, an average of 1 year

Procedure-related complication

loss rate of clipsthrough study completion, an average of 1 year

The rate of detachment of clips before surgery

Trial Locations

Locations (1)

National Cancer Center

🇰🇷

Goyang-si, Gyeonggi-do, Korea, Republic of

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