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

NCT06715332 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-12-04

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Chinese University of Hong Kong

    lead OTHER

Principal Investigators

  • Hon Chi Yip, MBChB · Chinese University of Hong Kong

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-08
Primary Completion
2025-12-31
Completion
2026-03-31

Countries

  • Hong Kong

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06715332 on ClinicalTrials.gov