Colon PolypNCT06715332
Prospective Study of Using Novel Bipolar Scissors in Colorectal Endoscopic Submucosal Dissection
A study testing Colorectal ESD with SpydrBlade Flex in people with Colon Polyp and Colon Neoplasia, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Colon Polyp, Colon Neoplasia
- What is being tested?
- Colorectal ESD with SpydrBlade Flex
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteHong Kong
- Study dates
- 8 Dec 2024to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Safety and Efficacy of the Novel SpydrBlade Flex With Radiofrequency and Microwave Ablation Flexible Bipolar for Colorectal Endoscopic Submucosal Dissection - A Prospective Study
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.
Read the detailed description
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.
- Conditions
- Colon Polyp, Colon Neoplasia
- Being tested
- Colorectal ESD with SpydrBlade Flex
- Keywords
- Endoscopic submucosal dissection
- Medical subject headings
- Colonic Polyps, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colorectal ESD with SpydrBlade FlexDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Endoscopic submucosal dissection with SpydrBlade Flex | Experimental | This group of patient would undergo endoscopic submucosal dissection with the use of the novel SpydrBlade Flex knife Receives: Device: Colorectal ESD with SpydrBlade Flex |
What is being measured
The primary outcome is the main question the study is designed to answer.
En-bloc resection rate
Defined by complete macroscopic resection of the target neoplasia in one single specimen
Measured: 30 days
Secondary outcomes (6)
R0 resection rate
Defined by histologically margin negative resection (Both horizontal and vertical margins)
Measured: 30 days
Curative resection rate
Defined by R0 resection and fulfilling existing histological curative resection criteria based on JGES guidelines
Measured: 30 days
Adverse event rate
Overall adverse event rate, according to ASGE lexicon
Measured: 30 days
Rate of adverse event - hemorrhage
Rate of intraprocedural and post procedural delayed hemorrhage
Measured: 30 days
Rate of adverse event - perforation
Rate of intraprocedural and post procedural delayed perforation
Measured: 30 days
Rate of adverse event - post-ESD coagulation syndrome
Defined by post-procedural abdominal pain and systemic inflammatory response
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start8 Dec 2024 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon PolypStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hon Chi Yip, Chinese University of Hong Kong
- Investigators
- Hon Chi Yip, MBChB, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06715332
- Sponsor's protocol ID
- CRE-2024.495
- Status last verified
- Nov 2024
- First submitted
- 29 Nov 2024
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of the Novel SpydrBlade Flex With Radiofrequency and Microwave Ablation Flexible Bipolar for Colorectal Endoscopic Submucosal Dissection - A Prospective Study
- ClinicalTrials.gov ID
- NCT06715332
- Acronym / sponsor ID
- CRE-2024.495
- Conditions
- Colon Polyp, Colon Neoplasia
- Keywords
- Endoscopic submucosal dissection
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 8 Dec 2024 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 4 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Endoscopic submucosal dissection with SpydrBlade Flex | Experimental | Device: Colorectal ESD with SpydrBlade FlexThis group of patient would undergo endoscopic submucosal dissection with the use of the novel SpydrBlade Flex knife |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (7 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colorectal ESD with SpydrBlade FlexThe 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. | Device | Endoscopic submucosal dissection with SpydrBlade Flex |
Primary outcome
En-bloc resection rate
Time frame: 30 days
Defined by complete macroscopic resection of the target neoplasia in one single specimen
6 secondary outcomes
R0 resection rate
Time frame: 30 days
Curative resection rate
Time frame: 30 days
Adverse event rate
Time frame: 30 days
Rate of adverse event - hemorrhage
Time frame: 30 days
Rate of adverse event - perforation
Time frame: 30 days
Rate of adverse event - post-ESD coagulation syndrome
Time frame: 30 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hon Chi Yip, MBChB principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colorectal ESD with SpydrBlade Flex in people with Colon Polyp and Colon Neoplasia, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hon Chi Yip, MBChB (35052627, hcyip@surgery.cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
En-bloc resection rate (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2024.