The Chinese University of Hong Kong
Hong Kong
NCT Number: NCT06715332
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.
Trial opening soon.
Get Notified18 year–80 year
All sexes
Interventional
Not applicable
Hong Kong
This is a prospective study with the following study Objectives:
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 30 days
Defined by complete macroscopic resection of the target neoplasia in one single specimen
Time frame: 30 days
Defined by histologically margin negative resection (Both horizontal and vertical margins)
Time frame: 30 days
Defined by R0 resection and fulfilling existing histological curative resection criteria based on JGES guidelines
Time frame: 30 days
Overall adverse event rate, according to ASGE lexicon
Time frame: 30 days
Rate of intraprocedural and post procedural delayed hemorrhage
Time frame: 30 days
Rate of intraprocedural and post procedural delayed perforation
Time frame: 30 days
Defined by post-procedural abdominal pain and systemic inflammatory response
Time frame: 1 day
Duration of ESD
Time frame: 1 day
Failure of device to continue the procedure
Time frame: 1 day
Rate of changing to other ESD knife
Contact information is provided by the study sponsor or research team.
Chinese University of Hong Kong
Other
Safety and Efficacy of the Novel SpydrBlade Flex With Radiofrequency and Microwave Ablation Flexible Bipolar for Colorectal Endoscopic Submucosal Dissection - A Prospective Study
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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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