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

NCT06715332 | Not Yet Recruiting

• 1 other identifier: CRE-2024.495
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Colon Polyp; Colon Neoplasia

Keywords

Endoscopic submucosal dissection

Outcome Measures

Primary Outcomes (1)

• En-bloc resection rate

  Defined by complete macroscopic resection of the target neoplasia in one single specimen

  30 days

Secondary Outcomes (6)

• R0 resection rate

  30 days

• Curative resection rate

  30 days

• Adverse event rate

  30 days

• Rate of adverse event - hemorrhage

  30 days

• Rate of adverse event - perforation

  30 days

Other Outcomes (3)

• Procedure time

  1 day

• Device dysfunction

  1 day

• Need for change to other device

  1 day

Study Arms (1)

Endoscopic submucosal dissection with SpydrBlade Flex

EXPERIMENTAL

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

Device: Colorectal ESD with SpydrBlade Flex

Interventions

Colorectal ESD with SpydrBlade Flex DEVICE

The allocated intervention would be performed under sedation or monitored anaesthesia by experienced endoscopists with at least 50 case experience of colon ESD. Colon ESD procedure would be performed as per described in the literature. After submucosal injection of solution to create a cushion, mucosal incision and submucosal dissection would be performed with the SydrBlade Flex. Submucosal plane dissection will be performed using the SpydrBlade Flex (BRF, cutting frequency 400kHz, power setting 35W). The exact resection strategy would be according to the endoscopists' preference, including different adjunctive techniques such as countertraction, tunnelling or pocket creation method. Upon completion of ESD, the resultant mucosal defect would be examined for any perforation or bleeding.

Endoscopic submucosal dissection with SpydrBlade Flex

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Colonic Polyps; Colonic Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Hon Chi Yip, MBChB

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hon Chi Yip, MBChB

CONTACT

35052627; hcyip@surgery.cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 29, 2024
• First Posted: December 4, 2024
• Study Start: December 8, 2024
• Primary Completion: December 31, 2025
• Study Completion: March 31, 2026
• Last Updated: December 4, 2024

Record last verified: 2024-11

Locations

HK (1)