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

NCT07754955 | Recruiting

• 1 other identifier: Si 745/2024
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Non-pedunculated Colorectal Polyp Size > 20 mm

Keywords

Endoscopic submucosal dissection, needle knfe, Speedboat

Outcome Measures

Primary Outcomes (1)

• The resection speed of colorectal endoscopic submucosal dissection using a Speedboat device compared with the standard needle knife.

  Resection speed was calculated using the following formulation. Resection speed = ((specimen diameter in the long axis, mm) x (specimen diameter in the short axis, mm) x 3.14 x 0.25) /procedure time (min). In case of patients with multiple lesions, the biggest lesion will be included in the study

  During the procedure

Secondary Outcomes (2)

• The en bloc resection rate and curative resection(R0) rate between using Speedboat and needle knife in colorectal ESD

  2 weeks after procedure

• The intraprocedural and postprocedural complications of using Speedboat and needle knife in colorectal ESD.

  30-days after procedure

Study Arms (2)

Speedboat group

EXPERIMENTAL

The lesion will be removed using the Speedboat device, which combines injection, cu

Device: Speedboat

Needle knife group

ACTIVE COMPARATOR

The lesion will be removed using the standard needle knife and other separate tools for injection and hemostasis.

Device: Needle knife

Interventions

Speedboat DEVICE

ESD procedure was performed using conventional, pocket-creation, or tunnel methods, depending on the endoscopist's decision. Speedboat group, any of the 2.8, 3.2, or 3.7 mm Speedboat devices is used in all procedure steps, including submucosal injection, mucosal incision, submucosal dissection, and vessel coagulation. A 25G injection needle can be used to initiate the submucosal injection in the case of using a 2.8 mm Speedboat device. If any devices other than Speedboat were used in the procedure, those should be recorded.

Speedboat group

Needle knife DEVICE

ESD procedure was performed using conventional, pocket-creation, or tunnel methods, depending on the endoscopist's decision. In needle knife gropu, a 25G injection needle is used in the initial submucosal injection step. A 1.5 mm needle knife is used for mucosal incision, submucosal dissection, and additional submucosal injection. Coagrasper is used for coagulating submucosal vessels. All used devices were recorded.

Needle knife group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Division of Gastroenterology, Departmnt of Medicine, Faculty of Medicine Siriraj Hospital

Bangkok Noi, Bangkok, 10700, Thailand

RECRUITING

Central Study Contacts

Dr. Onuma Sattayalertyanyong, MD.

CONTACT

+6681-6165389; onuma.gimed@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 5, 2026
• First Posted: August 10, 2026
• Study Start: October 4, 2024
• Primary Completion (Estimated): March 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: August 10, 2026

Record last verified: 2025-10

Locations

TH (1)