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Can a freezing balloon zap away precancerous gut growths?

NCT ID NCT03847636

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 04, 2026 · Last updated Aug 06, 2026 · Updated 2 times

Summary

This trial tests whether a freezing balloon, called cryoballoon ablation, can safely and effectively remove non-cancerous but potentially precancerous growths (adenomas) in the duodenum, the first part of the small intestine. The study includes people with sporadic adenomas or those with a genetic condition called familial adenomatous polyposis (FAP) who are not good candidates for surgery or standard removal. The procedure uses a catheter to freeze and destroy the abnormal tissue, and the trial will measure how completely the growths are eradicated and whether any complications occur.

What this could mean

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

Active substance
Cryoballoon ablation (a freezing catheter that destroys abnormal tissue in the duodenum)
What this could lead to
If effective, this freezing technique could offer a less invasive way to treat duodenal adenomas, potentially avoiding surgery or repeated endoscopic procedures.
What could go wrong
This is a small, early-stage trial. The procedure may cause side effects like pain, bleeding, or incomplete removal, and results may not apply to all patients.

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

33 people

The number who actually took part.

Started

May 2019

Finished

Jun 2026

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: * Sporadic duodenal adenomas between 1 to 5 cm in widest diameter * FAP patient with Spigelman class 2, 3 or 4 (see definition below) * Polyp characteristics: Non-polypoid lesions Paris 2A and 2B, or * Sessile adenomas, occupying no more than 50% circumference of duodenum, and no more than 3 duodenal folds * Individuals must be considered high risk for surgery or endoscopic resection, due to complication risk, or declined standard therapies. * Prior endoscopic mucosal resection (EMR) or saline-assisted polypectomy allowed if polyp characteristics meet inclusion criteria. Exclusion Criteria: * Suspected or proven duodenal carcinoma * Paris 1p pedunculated, Paris 2c, or 3 lesions * Paris 1s lesion \> 4 mm thick (estimated with closed biopsy forceps) * Ampullary lesion or lesion involving the ampulla * Prior failed ablative treatment with Argon Plasma Coagulation, laser, or cryotherapy * Pre-existing esophageal, gastric, pyloric, or duodenal stenosis/stricture preventing advancement of a therapeutic endoscope during screening/baseline esophagogastroduodenoscopy (EGD.) Subjects are eligible if the stenosis/stricture is dilated to at least 15mm, but baseline treatment may need to be delayed. * Any endoscopically-visualized abnormalities such as ulcers, masses or nodules during screening/baseline EGD within 3 cm of the treatment area. * Subjects with nodular polyps or suspicion of invasive cancer by white light endoscopy /enhanced imaging/biopsy identified during screening/baseline EGD * Suspicion of malignancy by abdominal or endoscopic ultrasound imaging based on malignant lymph nodes, invasion of lesion beyond mucosa. * EMR or polypectomy \< 6 weeks prior to baseline treatment. * Untreated invasive esophageal malignancy, including margin-positive EMR. * Active duodenitis in treatment zone during screening/baseline EGD. * Severe medical comorbidities precluding endoscopy, or limiting life expectancy to less than 2 years in the judgment of the endoscopist. * Uncontrolled coagulopathy or inability to be off anticoagulation or anti-platelet medication per standards of the institutions performing cryoablation. * Known portal hypertension, visible esophageal, gastric, or duodenal varices, or history of varices. * General poor health, multiple co-morbidities placing the patient at risk, or otherwise unsuitable for trial participation. * Pregnant or planning to become pregnant during period of study participation. * Patient refuses or is unable to provide written informed consent.

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Conditions

The condition(s) this trial relates to.

Adenomatous Polyposis Coli classic familial adenomatous polyposis

As listed by the trial registrant

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

Contacts and locations

Locations

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822, United States

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21287, United States

  • Methodist Dallas Medical Center

    Dallas, Texas, 75203, United States

  • Northwell Health

    Manhasset, New York, 11030, United States

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