Clinical trial · Interventional
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
NCT06715332CI-TRIAL-00083320not yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Neoplasia | — | UNRESOLVED | — |
| Colon Polyp | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Colorectal ESD with SpydrBlade Flex | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Endoscopic submucosal dissection with SpydrBlade Flex
- description
- This group of patient would undergo endoscopic submucosal dissection with the use of the novel SpydrBlade Flex knife
- interventionNames
- Device: Colorectal ESD with SpydrBlade Flex
Primary outcomes (1)
- measure
- En-bloc resection rate
- timeFrame
- 30 days
- description
- Defined by complete macroscopic resection of the target neoplasia in one single specimen
Secondary outcomes (6)
- measure
- R0 resection rate
- timeFrame
- 30 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion criteria: * 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). Exclusion criteria: * 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.
References
Publications (0)
Data not yet available
No reference posted for this study.