Can a freezing balloon zap away precancerous gut growths?
NCT ID NCT03847636
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
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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
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33 people
The number who actually took part.
- Started
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May 2019
- Finished
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Jun 2026
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
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Johns Hopkins Hospital
Baltimore, Maryland, 21287, United States
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Methodist Dallas Medical Center
Dallas, Texas, 75203, United States
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Northwell Health
Manhasset, New York, 11030, United States
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