Prospective Study of Using Novel Bipolar Scissors in Colorectal Endoscopic Submucosal Dissection

Launched by CHINESE UNIVERSITY OF HONG KONG · Nov 29, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at a new tool called the SpydrBlade Flex, which uses advanced technology to help doctors safely remove certain types of growths in the colon, known as superficial colorectal neoplasia. These growths can be benign (non-cancerous) like adenomas or early-stage cancers. The study aims to see how effective and safe this new device is during a procedure called endoscopic submucosal dissection (ESD), which is a method used to remove these growths from the lining of the colon.

To participate in this study, you need to be an adult aged between 18 and 80 years, and you should be scheduled for the ESD procedure for a suitable lesion. However, there are some people who won't be able to join, such as those with certain serious health conditions, pregnant women, or those who can't provide consent. If you decide to take part, you'll be closely monitored during the procedure, and the study will help researchers understand if this new tool improves the way doctors treat these types of colon growths.

Gender

ALL

Eligibility criteria

• Inclusion criteria:
• • Adult patient (age ≥18 and ≤80 years-old)
• • Capability of understanding and complying with the study requirements, including signing the informed consent form.
• • Patients with colorectal superficial mucosal neoplasia (clinically adenoma or early intramucosal cancer), scheduled to undergo endoscopic submucosal dissection (ESD).
• Exclusion criteria:
• • Patients unable or unwilling to provide consent.
• • Patients with lesions unsuitable for ESD, including those suspicious of deep submucosal invasive cancer.
• • Patients with lesions involving the appendiceal orifice or ileocaecal valve.
• • Patients with significant cardiorespiratory comorbidities which may limit their ability to undertake monitored anesthesia for the procedure.
• • Poor performance status (Eastern Cooperation Oncology Group performance status ≥3).
• • Pregnant women or those planning pregnancy or breastfeeding women.
• • Uncorrectable coagulopathy defined by international normalized ratio (INR) \> 1.5 or platelet count \< 50000/µl.