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Can a single tool outperform the standard for colon polyp removal?

NCT ID NCT07754955

Disease control Sponsor: Mahidol University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 10, 2026 · Last updated Aug 11, 2026 · Updated 1 time

Summary

This trial tests whether a new device called the Speedboat can remove large, flat colon polyps as well as or better than the standard needle knife. The Speedboat combines injection, cutting, and bleeding control in one tool, while the needle knife requires separate instruments. About 80 adults with polyps larger than 20 mm will be randomly assigned to one of the two methods. The study compares how fast the polyp is removed, how often it is removed in one piece with clear margins, and the safety of each approach.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Speedboat device (a combined injection, cutting, and coagulation tool) compared with a standard needle knife for endoscopic submucosal dissection.
What this could lead to
If the Speedboat device proves faster and safer, it could become a preferred tool for removing large colon polyps, reducing procedure time and complications.
What could go wrong
This is a relatively small, early-stage study. The device may not outperform the standard needle knife, and there are inherent risks like bleeding or perforation during the procedure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Non-pedunculated colorectal polyp size > 20 MM

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

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

    RECRUITING

    Bangkok Noi, Bangkok, 10700, Thailand