NCT06715332

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

Safety and Efficacy of the Novel SpydrBlade Flex With Radiofrequency and Microwave Ablation Flexible Bipolar for Colorectal Endoscopic Submucosal Dissection - A Prospective Study

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Chinese University of Hong Kong · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colon Polyp
• Colon Neoplasia

Interventions

Type	Name	Description
DEVICE	Colorectal ESD with SpydrBlade Flex	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.

Timeline

• Start date: 2024-12-08
• Primary completion: 2025-12-31
• Completion: 2026-03-31
• First posted: 2024-12-04
• Last updated: 2024-12-04

Locations

1 site across 1 country: Hong Kong