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New cutting tool may outperform heat therapy for Barrett's esophagus

NCT ID NCT04867590

Disease control Sponsor: University Hospital, Angers 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 30, 2026 · Last updated Jul 01, 2026 · Updated 1 time

Summary

This study tests a new device called EndoRotor, which mechanically removes the damaged lining of the esophagus, against the standard heat-based radiofrequency treatment for people with Barrett's esophagus who have precancerous cells (dysplasia). The goal is to see if the new method can completely eliminate the abnormal tissue in a single session, while also allowing for tissue analysis. About 140 adults with Barrett's esophagus measuring 2 to 6 cm will take part, and the main check happens 3 months after treatment.

What this could mean

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

Active substance
EndoRotor device (mechanical mucosal resection system)
What this could lead to
If successful, EndoRotor could offer a more effective, one-session treatment for Barrett's esophagus, potentially reducing the risk of hidden precancerous glands and lowering costs.
What could go wrong
This is a relatively early comparison study with 140 participants. The new technique may not prove superior, and carries risks like perforation or bleeding. Long-term outcomes are not yet known.

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 140 people

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

Started

Mar 2022

Expected to finish

Jul 2031

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

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: * Adult patients presenting Barrett's esophagus of a size between 2 cm and 6 cm in the height of the longest tonguea with low to high grade dysplasia that is histologically proven or with a superficial non-invasive adenocarcinoma that has been resected a The total height of the BE is evaluated according to the Prague classification, with the height of the circumferential segment between 0 cm (non-circumferential segment) and 6 cm (segment shaped like a full sleeve for 6 cm), referred to as C0 to C6, and the height of the longest tongue between 2 cm and 6 cm (M2- M6). * Patients must have signed the consent form in order to participate in the study * Patients are pre-included (signature of consent) before the histological confirmation of dysplasiab and/or superficial non-invasive adenocarcinoma that allows the patient to be included in the study. Exclusion Criteria: * Individuals over 85 years old * Women who are pregnant, breastfeeding or in labour * Individuals in detention through judicial or administrative decision * Individuals who are the subject of psychiatric treatment under duress * Individuals who are subjects of legal protection measures * Individuals who are in no state to give their consent * Individuals who do not understand French or do not know how to read * Individuals who are not part of a social security program or benefit from such a scheme * Those with active peptic and/or radiation-induced or complicated esophagitis at the time of treatment * Presence of a visible lesion that is suspected to be esophageal cancer confirmed by biopsies * Anterior resection of invasive adenocarcinoma using endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD) with invasion of the lateral and/or deep margin, adenocarcinoma of poorly differentiated characteristics or sub-mucosal invasion \> 500µm (pT1b) * All preliminary ablation treatments or dilation for esophageal stenosis * Significant esophageal stenosis: cannot be passed with a standard gastroscope * Presence of esophageal varices or portal hypertension * Anticoagulant treatment that cannot be stopped before the intervention (excluding 100 mg maximum per day of aspirin in single-drug treatment) or any haemostasis problems that cannot be corrected * Having a contraindication regarding anaesthesia * Patients incapable of taking proton pump inhibitors (PPIs) orally.

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Conditions

The condition(s) this trial relates to.

Barrett adenocarcinoma Barrett esophagus

As listed by the trial registrant

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

Barrett esophagus Dysplasia

How to take part

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

  1. The places running it

    15 sites. 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

  • Cochin Hospital

    ACTIVE_NOT_RECRUITING

    Paris, France

  • Edouard Herriot Hospital

    RECRUITING

    Lyon, France

  • Georges Pompidou European Hospital

    WITHDRAWN

    Paris, France

  • UNiversity Hospital of Toulouse

    RECRUITING

    Toulouse, France

  • University Hospital of Besançon

    RECRUITING

    Besançon, France

  • University Hospital of Bordeaux

    RECRUITING

    Pessac, France

  • University Hospital of Brest

    NOT_YET_RECRUITING

    Brest, France

  • University Hospital of Dijon

    RECRUITING

    Dijon, France

  • University Hospital of Lille

    RECRUITING

    Lille, France

  • University Hospital of Limoges

    RECRUITING

    Limoges, France

  • University Hospital of Montpellier

    RECRUITING

    Montpellier, France

  • University Hospital of Nancy

    RECRUITING

    Nancy, France

  • University Hospital of Nantes

    RECRUITING

    Nantes, France

  • University Hospital of Nice

    NOT_YET_RECRUITING

    Nice, France

  • University Hospital of Poitiers

    NOT_YET_RECRUITING

    Poitiers, France

  • University Hospital of Rennes

    NOT_YET_RECRUITING

    Rennes, France

  • University Hospital of Tours

    RECRUITING

    Chambray-lès-Tours, France

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