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Not yet recruiting NCT06715332

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

No phase Interventional Colon Polyp Colon Neoplasia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Colorectal ESD with SpydrBlade Flex.
Who it may be relevant to
Registry conditions: Colon Polyp, Colon Neoplasia. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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.

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 settin

Primary outcome measures

  • En-bloc resection rate [Time frame: 30 days]
Secondary outcome measures (6)
  • R0 resection rate [Time frame: 30 days]
  • Curative resection rate [Time frame: 30 days]
  • Adverse event rate [Time frame: 30 days]
  • Rate of adverse event - hemorrhage [Time frame: 30 days]
  • Rate of adverse event - perforation [Time frame: 30 days]
  • Rate of adverse event - post-ESD coagulation syndrome [Time frame: 30 days]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Hong Kong · 1 center
  • The Chinese University of Hong Kong — Hong Kong

Identifiers

NCT: NCT06715332 · CRE-2024.495

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗