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New bipolar knife could make esophageal surgery safer

NCT ID NCT06476678

Symptom relief Sponsor: Baylor College of Medicine 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a new device called the Speedboat™ Ultraslim, a bipolar radiofrequency knife, for removing precancerous growths in the esophagus. Researchers want to see if it works well and is safe compared to standard tools. The trial will involve 50 adults at two medical centers.

What this could mean

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

Active substance
Speedboat™ Ultraslim bipolar radiofrequency ablation knife
What this could lead to
If successful, this device could make esophageal lesion removal faster and safer, reducing complications for patients.
What could go wrong
This is a small, early-stage trial with only 50 participants. The new knife may not work better than existing tools, and there are risks like bleeding or injury 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.

Participants

About 50 people

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

Started

Oct 2024

Expected to finish

Dec 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.

Who is studied

All patients undergoing intended ESD of precancerous lesions will be screened by study coordinators for preliminary eligibility and those who meet the inclusion criteria will be approach individually for further discussion about the study and obtaining informed consent.

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: * Patient is \>18 years of age * Patient can provide informed consent * Patient is referred for resection of precancerous lesions meeting the following criteria: * Mucosal based polyp * Located gastroesophageal junction (GEJ) or proximal to GEJ * No previous endoscopic resection attempted (EMR or ESD) Exclusion Criteria: * Patients with International Normalized Ratio (INR) \>1.5 or Platelets \<50,000 * Lesions extending past GEJ * Subepithelial lesions

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Conditions

The condition(s) this trial relates to.

benign neoplasm of esophagus Esophageal Neoplasms neoplasm of esophagus

As listed by the trial registrant

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

Bipolar electrocautery Endoscopic submucosal dissection Esophageal neoplasm Esophageal polyp

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

  • Baylor College of Medicine

    RECRUITING

    Houston, Texas, 77030, United States

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