An interventional study of Colorectal ESD with SpydrBlade Flex in Colon Polyp and Colon Neoplasia, sponsored by Chinese University of Hong Kong. Not yet recruiting at 1 site in Hong Kong. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-12-04.
Sponsored by Chinese University of Hong Kong · Not applicable, Interventional, and Treatment
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.
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.
377 studies on the registry are indexed under Colonic Polyps; 57 are open to participants now.
This study's planned enrollment of 30 is below the median of 274 across 250 interventional studies indexed under Colonic Polyps.
Browse Colonic Polyps studies →Chinese University of Hong Kong is the lead sponsor of 1,454 studies on the registry; 474 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This group of patient would undergo endoscopic submucosal dissection with the use of the novel SpydrBlade Flex knife
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 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.
En-bloc resection rate
Defined by complete macroscopic resection of the target neoplasia in one single specimen
Time frame: 30 days
R0 resection rate
Defined by histologically margin negative resection (Both horizontal and vertical margins)
Time frame: 30 days
Curative resection rate
Defined by R0 resection and fulfilling existing histological curative resection criteria based on JGES guidelines
Time frame: 30 days
Adverse event rate
Overall adverse event rate, according to ASGE lexicon
Time frame: 30 days
Rate of adverse event - hemorrhage
Rate of intraprocedural and post procedural delayed hemorrhage
Time frame: 30 days
Rate of adverse event - perforation
Rate of intraprocedural and post procedural delayed perforation
Time frame: 30 days
Rate of adverse event - post-ESD coagulation syndrome
Defined by post-procedural abdominal pain and systemic inflammatory response
Time frame: 30 days
Procedure time
Duration of ESD
Time frame: 1 day
Device dysfunction
Failure of device to continue the procedure
Time frame: 1 day
Need for change to other device
Rate of changing to other ESD knife
Time frame: 1 day
Plan to share: Undecided
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
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Chinese University of Hong Kong →