Prospective Study of Using Novel Bipolar Scissors in Colorectal Endoscopic Submucosal Dissection
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorChinese University of Hong Kong
About this trial
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.
Eligibility criteria
Qualifiers
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).
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Colorectal ESD with SpydrBlade Flex
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov