NCT06715332Not yet recruiting
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
Source: ClinicalTrials.gov · Last updated 4 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 29 Nov 2024
- Start date
- 8 Dec 2024
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Chinese University of Hong Kong
- NCT number
- NCT06715332
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 8 Dec 2024 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients with lesions unsuitable for ESD, including those suspicious of deep submucosal invasive cancer.
Lab values
- Uncorrectable coagulopathy defined by international normalized ratio (INR) \> 1.5 or platelet count \< 50000/µl.
Other
- Patients unable or unwilling to provide consent.
- 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.
Who the study is looking for
- 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).
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Chinese University of Hong Kong Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.