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ICG-coated Endoscopic Clip for Tumor Localization

N

National Cancer Center (NCC)

Status

Completed

Conditions

Colorectal Neoplasms

Treatments

Device: ICG-coated clip

Study type

Interventional

Funder types

Other

Identifiers

NCT03924349
NCC2019-0046

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

20 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

30 participants in 1 patient group

ICG clip
Experimental group
Description:
Three clips are fixed in three directions (120 degrees apart) at the distal of the lesion (just distal) before surgery
Treatment:
Device: ICG-coated clip

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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