Comparison of Efficacy and Safety of Speedboat Device and Needle Knife for Colorectal Endoscopic Submucosal Dissection: a Multicenter Randomized Study

Recruiting now · Not applicable

Conditions studied: Non-pedunculated Colorectal Polyp Size > 20 mm

In brief

The goal of this clinical trial is to learn whether a new endoscopic device called the Speedboat works as well or better than the standard needle knife for removing large colonic nonpedunculated polyps. The study will also evaluate the safety of the Speedboat device. The main aims of the study are: * To compare the resection speed of colorectal endoscopic submucosal dissection (ESD) using the Speedboat device versus the standard needle knife. * To compare the en bloc resection rate and curative (R0) resection rate between the two techniques. * To evaluate the safety of using the Speedboat device compared with the needle knife in colorectal ESD. What will happen in this study Adults aged 18 years or older who have a large, flat colorectal polyp (greater than 20 mm) that cannot be safely removed with standard snare polypectomy may take part. Participants will be randomly assigned (like flipping a coin) to one of two groups: * Speedboat group: The lesion will be removed using the Speedboat device, which combines injection, cutting, and bleeding control in one tool. * Needle knife group: The lesion will be removed using the standard needle knife and other separate tools for injection and hemostasis. What participants will do Stay one night in the hospital before the colonoscopy for bowel preparation. Undergo colonoscopy and lesion removal under anesthesia. Have blood tests and monitoring for one day after the procedure. Be followed for two weeks to check for any complications. Have a follow-up colonoscopy 6-12 months later, depending on pathology results. Where and how the study will be done The study will take place at five hospitals in Thailand: Faculty of Medicine Siriraj Hospital, Mahidol University King Chulalongkorn Memorial Hospital Rajavithi Hospital National Cancer Institute of Thailand Phra Nakhon Si Ayutthaya Hospital About 80 participants will join the study. All procedures will be performed by experienced endoscopists who have performed at least 50 colorectal ESD cases.

Key facts

Study ID: NCT07754955
Run by: Mahidol University
People needed: 80
Starts: 2024-10-04
Expected to finish: 2027-09-30
Last updated by the study team: 2026-08-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Age 18 or above with large non-pedunculated colorectal polyp size > 20 mm. in which 1st endoscopist decided that lesion cannot be resected with endoscopic mucosal resection to achieve en bloc resection

You may not qualify if…

Patients who have coagulopathy which is contraindicated for colonoscopy and polypectomy (Prothrombin time > 3-second ULN, INR > 1.5, Platelet < 50,000)
The non-pedunculated lesion that was recurrence from the previous polypectomy or ESD
Suspected deep submucosal invasion using image-enhanced endoscopy by expert endoscopist
Patients who were diagnosed with inflammatory bowel disease
Pregnancy or breastfeeding
A patient who is unable to provide consent

Where it is running

Division of Gastroenterology, Departmnt of Medicine, Faculty of Medicine Siriraj Hospital — Bangkok Noi, Bangkok, Thailand (enrolling)

Full record on ClinicalTrials.gov

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