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NCT Number: NCT06715332

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

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.

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Key information

About this study

This is a prospective study with the following study Objectives:

  • To evaluate the safety and effectiveness of a novel radiofrequency and microwave ablation flexible bipolar (SpydrBlade Flex, CREO Medical, UK) for colorectal ESD.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. En-bloc resection rate

    Time frame: 30 days

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

Secondary outcomes

  1. R0 resection rate

    Time frame: 30 days

    Defined by histologically margin negative resection (Both horizontal and vertical margins)

  2. Curative resection rate

    Time frame: 30 days

    Defined by R0 resection and fulfilling existing histological curative resection criteria based on JGES guidelines

  3. Adverse event rate

    Time frame: 30 days

    Overall adverse event rate, according to ASGE lexicon

  4. Rate of adverse event - hemorrhage

    Time frame: 30 days

    Rate of intraprocedural and post procedural delayed hemorrhage

  5. Rate of adverse event - perforation

    Time frame: 30 days

    Rate of intraprocedural and post procedural delayed perforation

  6. Rate of adverse event - post-ESD coagulation syndrome

    Time frame: 30 days

    Defined by post-procedural abdominal pain and systemic inflammatory response

Other outcomes

  1. Procedure time

    Time frame: 1 day

    Duration of ESD

  2. Device dysfunction

    Time frame: 1 day

    Failure of device to continue the procedure

  3. Need for change to other device

    Time frame: 1 day

    Rate of changing to other ESD knife

Study contacts

Contact information is provided by the study sponsor or research team.

Hon Chi Yip, MBChB

CONTACT

[email protected]

35052627

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Dec 4, 2024
Registry last updated
Dec 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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