Speedboat device vs needle knife for large colorectal polyps
Official title: Comparison of Efficacy and Safety of Speedboat Device and Needle Knife for Colorectal Endoscopic Submucosal Dissection: a Multicenter Randomized Study
Run by Mahidol University · NCT07754955 · Data updated 2026-11-12
This trial tests whether the Speedboat endoscopic device can remove large non-pedunculated colorectal polyps as well as or better than the standard needle knife in adults.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Mahidol University Academic / other |
| Locations | 1 site (Bangkok Noi, Bangkok) |
| Status | Recruiting |
| Started | October 4, 2024 |
| Main results expected | March 30, 2027 |
| Study ends | September 30, 2027 |
| Registry record updated | August 10, 2026 |
| Trial ID | NCT07754955 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults 18 years or older with a large (>20 mm), flat, non-pedunculated colorectal polyp where en bloc resection is not possible with standard methods.
✕Probably not a fit
Patients whose polyps are unsuitable for Speedboat use or who experience no improvement in resection outcomes may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This multicenter randomized study compares two endoscopic techniques for removing large (>20 mm) non-pedunculated colorectal polyps. Participants are adults who cannot be safely resected with standard snare polypectomy and are randomized to use either the Speedboat device or the traditional needle knife during endoscopic submucosal dissection. Outcomes include resection speed, en bloc resection rate, and R0 (curative) resection rate, along with safety measures. The study builds on established ESD approaches to improve complete resection while monitoring adverse events. The lead sponsor is Mahidol University, with the study conducted at Siriraj Hospital in Bangkok, Thailand.
Why it matters
Potential benefit: If successful, patients may experience faster procedures and higher rates of complete, curative resections with the Speedboat device.
How similar studies have gone: Prior endoscopic approaches for large colorectal polyps show promise with ESD, but direct comparisons of Speedboat to needle knife are novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: 1. Patients who have coagulopathy which is contraindicated for colonoscopy and polypectomy (Prothrombin time \> 3-second ULN, INR \> 1.5, Platelet \< 50,000) 2. The non-pedunculated lesion that was recurrence from the previous polypectomy or ESD 3. Suspected deep submucosal invasion using image-enhanced endoscopy by expert endoscopist 4. Patients who were diagnosed with inflammatory bowel disease 5. Pregnancy or breastfeeding 6. A patient who is unable to provide consent
Where it's running
-
Division of Gastroenterology, Departmnt of Medicine, Faculty of Medicine Siriraj Hospital
Bangkok Noi, Bangkok, Thailand Recruiting
Study contacts
- Study coordinator: Dr. Onuma Sattayalertyanyong, MD.
- Email: onuma.gimed@gmail.com
- Phone: +6681-6165389
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Balance exergame training for older adults who have fallen
This study tests balance-based video game training versus conventional balance training to see if it improves balance, brain activity, and function in older adults who have fallen before.
-
High BMI and periodontitis in Thai adults under 60
This study tests how common high BMI and periodontitis are among Thai adults aged 18–59 and what factors are linked to them.
-
Cardiovascular Risk in Thai MASLD Patients: Coronary Calcium Scores
This study tests how well common cardiovascular risk tools align with coronary calcium scores in Thai adults with MASLD who have no heart symptoms.
-
HSCT outcomes in children at Ramathibodi Hospital
This study tests how hematopoietic stem cell transplantation works in pediatric patients with blood diseases, cancers, and other conditions at Ramathibodi Hospital.
-
Shrimp Sensitization and Allergy in Edible Insect Allergy
This study tests whether people 7 and older who are allergic to edible insects also show shrimp sensitization or shrimp allergy, by using tests and risk-based food challenges.
-
Long-term Iron Absorption in Women with Overweight/Obesity vs Normal Weight
This study tests long-term iron absorption and loss in women aged 40–50, comparing those who are overweight/obese with those of normal weight.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.