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Completed

NCT Number: NCT03924349

ICG-coated Endoscopic Clip for Tumor Localization

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.

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Key information

Conditions

Colorectal Neoplasms Colonic Diseases Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Cancer Center

Goyang-si, Gyeonggi-do, 410-769, South Korea

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

ICG-coated clip

Device

Tumor localization using ICG-coated clip prior to surgery

Primary outcomes

  1. Success rate of localization

    Time frame: through study completion, an average of 1 year

    The rate of Identifying ICG-coated clip during surgery

Secondary outcomes

  1. loss rate of clips

    Time frame: through study completion, an average of 1 year

    The rate of detachment of clips before surgery

  2. Number of Participants with Complication

    Time frame: through study completion, an average of 1 year

    Procedure-related complication

Sponsors and collaborators

Lead sponsor

National Cancer Center, Korea

Other Gov

Registry information

Official study title

The Feasibility and Efficacy of ICG-coated Endoscopic Clip for Tumor Localization in Laparoscopic Colorectal Surgery

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Apr 23, 2019
Registry last updated
Nov 27, 2019

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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