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New knife may ease pain after throat surgery for swallowing problems

NCT ID NCT05272046

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study compared two different surgical knives used during a procedure called POEM, which treats swallowing disorders by cutting throat muscles. 104 adults were randomly assigned to receive either a standard monopolar knife or a newer bipolar knife (Speedboat-RS2). The goal was to see if the bipolar knife caused less pain after the procedure and made the surgery faster and easier.

What this could mean

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

Active substance
monopolar current cutting knife and bipolar RFA knife (Speedboat-RS2)
What this could lead to
If the bipolar knife works better, it could mean less pain after POEM and a smoother procedure for patients with swallowing disorders.
What could go wrong
This is a small, completed study comparing two tools already in use, so the results may not apply to all patients or settings. The main risk is that the bipolar knife may not reduce pain as hoped.

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

104 people

The number who actually took part.

Started

Feb 2022

Finished

Oct 2025

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 greater than or equal to 18 years of age * Able to sign consent - Planned POEM procedure for all indications Exclusion Criteria: * Pregnant patients * Prisoners * Unable to sign consent

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Conditions

The condition(s) this trial relates to.

Deglutition Disorders dyskinesia of esophagus Esophageal Achalasia

As listed by the trial registrant

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

Esophageal motility disorders

Contacts and locations

Locations

  • Asian Institute of Gastroenterology (AIG) Hospitals

    Hyderabad, 500082, India

  • Baylor College of Medicine

    Houston, Texas, 77030, United States

  • Navarra Hospital Complex - Navarra Hospital

    Pamplona, 31008, Spain

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