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

The Chinese University of Hong Kong

Status: Not yet enrolling

Conditions: Colon Neoplasia; Colon Polyp

Treatments: Device: Colorectal ESD with SpydrBlade Flex

Study type: Interventional

Funder types: Other

Identifiers

NCT06715332

CRE-2024.495

Details and patient eligibility

About

This study is an interventional, prospective, single-center study to evaluate the safety and effectiveness of a novel radiofrequency and microwave ablation flexible bipolar (SpydrBlade Flex, CREO Medical, UK) for colorectal ESD in patients with superficial colorectal neoplasia.

Full description

This is a prospective study with the following study Objectives:

1. To evaluate the safety and effectiveness of a novel radiofrequency and microwave ablation flexible bipolar (SpydrBlade Flex, CREO Medical, UK) for colorectal ESD.
2. To assess the impact of the procedure on patient recovery time and postoperative adverse event.

This study is an interventional, prospective, single-center study to evaluate the safety and effectiveness of a novel radiofrequency and microwave ablation flexible bipolar (SpydrBlade Flex, CREO Medical, UK) for colorectal ESD in patients with superficial colorectal neoplasia. Patients will undergo a ESD for superficial colorectal neoplasia. All ESD procedures will be performed by expert endoscopists with at least 50 prior experience of ESD.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Endoscopic submucosal dissection with SpydrBlade Flex

Experimental group

Description:

This group of patient would undergo endoscopic submucosal dissection with the use of the novel SpydrBlade Flex knife

Treatment:

Device: Colorectal ESD with SpydrBlade Flex