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

Not Applicable

Not yet recruiting

• Conditions: Colon Polyp; Colon Neoplasia

• Registration Number: NCT06715332
• Lead Sponsor: Chinese University of Hong Kong

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.

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-29
• Study First Submitted QC: 2024-11-29
• Last Update Submitted: 2024-11-29
• Study First Posted: 2024-12-04
• Last Update Posted: 2024-12-04
• Study Start: 2024-12-08
• Primary Completion: 2025-12-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
En-bloc resection rate	30 days	Defined by complete macroscopic resection of the target neoplasia in one single specimen

Secondary Outcome Measures

Name	Time	Method
R0 resection rate	30 days	Defined by histologically margin negative resection (Both horizontal and vertical margins)
Curative resection rate	30 days	Defined by R0 resection and fulfilling existing histological curative resection criteria based on JGES guidelines
Adverse event rate	30 days	Overall adverse event rate, according to ASGE lexicon
Rate of adverse event - hemorrhage	30 days	Rate of intraprocedural and post procedural delayed hemorrhage
Rate of adverse event - perforation	30 days	Rate of intraprocedural and post procedural delayed perforation
Rate of adverse event - post-ESD coagulation syndrome	30 days	Defined by post-procedural abdominal pain and systemic inflammatory response

Trial Locations

Locations (1)

The Chinese University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong