Clinical trial NCT06715332: Prospective Study of Using Novel Bipolar Scissors in Colorectal Endoscopic Submucosal Dissection
Official title: Safety and Efficacy of the Novel SpydrBlade Flex With Radiofrequency and Microwave Ablation Flexible Bipolar for Colorectal Endoscopic Submucosal Dissection - A Prospective Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Colon Polyp
Colon Neoplasia
Keywords: Endoscopic submucosal dissection
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2024-12-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

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.

Primary outcomes:
measure: En-bloc resection rate
timeFrame: 30 days
Secondary outcomes:
measure: R0 resection rate
timeFrame: 30 days
measure: Curative resection rate
timeFrame: 30 days
measure: Adverse event rate
timeFrame: 30 days
measure: Rate of adverse event - hemorrhage
timeFrame: 30 days
measure: Rate of adverse event - perforation
timeFrame: 30 days
measure: Rate of adverse event - post-ESD coagulation syndrome
timeFrame: 30 days
Other outcomes:
measure: Procedure time
timeFrame: 1 day
measure: Device dysfunction
timeFrame: 1 day
measure: Need for change to other device
timeFrame: 1 day
Locations:
city: Hong Kong
country: Hong Kong
facility: The Chinese University of Hong Kong
Study officials:
affiliation: Chinese University of Hong Kong
name: Hon Chi Yip, MBChB
role: PRINCIPAL_INVESTIGATOR
References: