Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Freezing out cancer risk: new balloon treatment for Barrett's esophagus

NCT ID NCT03311451

Disease control Sponsor: Merit Medical Systems, Inc. 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a device that freezes abnormal cells in the esophagus to treat Barrett's esophagus, a condition that can lead to cancer. About 62 adults with low- or high-grade dysplasia (precancerous changes) will receive the treatment. The goal is to see if the freezing balloon safely removes these abnormal cells and reduces the need for more invasive procedures.

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

62 people

The number who actually took part.

Started

Jan 2023

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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: 1. Patients with flat- type BE esophagus, with an indication for ablation therapy, defined as: * Diagnosis of LGD or HGD in BE (confirmed by central pathology review), OR * Residual BE with any grade of dysplasia 6 weeks after endoscopic resection 2. Prague Classification Score C≤3 and ≥M1 3. Patients should be ablation-naïve (no previous ablation therapy of the esophagus) 4. Older than 18 years of age at time of consent 5. Operable per institution's standards 6. Patient provides written informed consent on the IRB-approved informed consent form 7. Patient is willing and able to comply with follow-up requirements. Exclusion Criteria: 1. Esophageal stenosis preventing advancement of a therapeutic endoscope 2. Any endoscopically visualized lesion such as ulcers, masses or nodules. Neoplastic nodules must first be treated with ER ≥6 weeks prior to planned treatment under this protocol. 3. Prior ER of more than 2cm in length and/or \>50% of the esophageal lumen circumference 4. History of locally advanced (\>SM1) esophageal cancer 5. History of esophageal varices 6. Prior distal esophagectomy 7. Active esophagitis LA grade B or higher 8. Severe medical comorbidities precluding endoscopy 9. Uncontrolled coagulopathy 10. Pregnant or planning to become pregnant during period of study 11. Patient refuses or is unable to provide written informed consent 12. Participation in another study with investigational drug within the 30 days preceding or during the present study, interfering with participation in the current study 13. General poor health, multiple co-morbidities placing the patient at risk or otherwise unsuitable for trial participation

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Barrett esophagus are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

Barrett esophagus

As listed by the trial registrant

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

Barrett esophagus

Contacts and locations

Locations

  • AMC Medical Research B.V.

    Amsterdam, Netherlands, Netherlands

  • Catharina Hospital Eindhoven

    Eindhoven, Netherlands, Netherlands

  • Erasmus Medical Center

    Rotterdam, Netherlands, Netherlands

  • St. Antonius Hospital

    Nieuwegein, Netherlands

  • UMC Groningen

    Groningen, Netherlands, Netherlands

  • UMC Utrecht

    Utrecht, Netherlands, Netherlands

More trials for these conditions

Other studies related to the condition(s) this trial covers.