An interventional study of C2 CryoBalloon 180° Ablation System in Barrett Esophagus, sponsored by Merit Medical Systems, Inc.. Active, not recruiting at 6 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-22.
Sponsored by Merit Medical Systems, Inc. · Not applicable, Interventional, and Treatment
The primary objective is to determine the safety and efficacy of the C2 CryoBalloon 180 Ablation System ("CryoBalloon 180") used at decreasing doses in ablation naïve patients with low- or high-grade dysplastic Barrett's Esophagus (BE) or with residual BE after resection of dysplasia or early adenocarcinoma.
The procedure will be performed on an outpatient basis, and the CryoBalloon 180 Ablation system will be used for all ablations following the instructions for use provided with the product.
Patients who meet the eligibility criteria will be assigned to one of the treatment groups and doses, depending on the order of their enrollment:
In phase I, the first 62 patients will be treated with Dose 1 (lowest), in one application to ablate 50% of the esophageal circumference.
All patients will undergo 10 week (±2 weeks) follow-up EGD to evaluate efficacy of the dose before the study continues.
If follow-up shows that Dose 1 eradicates ≤60% of the treated BE (by median percentage) and no SAE's are reported, the treatment phase will continue but at the next incremental higher dose (Second Dose) after approval from the IRB.
If the Dose 1 median BE surface regression percentage is ≥60%, the dose is defined as the therapeutic dose. In that case, the study will be prematurely terminated without the consecutive treatment of an additional 62 patients with a higher dose.
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Dose-related SAEs include pain in the treatment area greater than 6 (0-10 NRS score) at 24 hours AND seven (7) days post-treatment; symptomatic stricture requiring an additional EGD with endoscopic dilation before the first follow-up EGD; symptomatic stricture at follow-up EGD; or any stricture (symptomatic or asymptomatic) preventing passage of the therapeutic endoscope at follow-up EGD. Any other serious adverse events within 30 days after treatment will also be evaluated by the Data and Safety Monitoring Board (DSMB) for relationship to the dose and severity.
Patients with flat- type BE esophagus, with an indication for ablation therapy, defined as:
Exclusion Criteria:
C2 CryoBalloon 180 Ablation System will be used to ablate visible Barrett's esophagus
Device: C2 CryoBalloon 180° Ablation System
The C2 CryoBalloon 180° Ablation System is a cryosurgical device with a nitrous oxide cooled balloon probe that is compatible with upper gastrointestinal therapeutic endoscopes.
Also known as: CryoBalloon 180
Efficacy: Dose response
Dose response (efficacy) is defined as eradication percentage of BE confirmed by histological evidence of eradication of BE, after treatment with the therapeutic dose.
Time frame: 10 weeks
Safety: Incidence of Dose-related SAEs
Safety will be evaluated by the incidence of Dose-related SAEs. Dose-related SAEs include pain in the treatment area, or any stricture (symptomatic or asymptomatic) preventing passage of the diagnostic endoscope at follow-up EGD.
Time frame: 30 days
Incidence of AEs
Incidence of all serious and non-serious adverse events up to 30 days post-treatment
Time frame: 30 days
Patient reported post-procedure pain
Post-procedure pain in the area of the cryoablation treatment (0-10 NRS score)
Time frame: 24hours, 7 days and 30 days post-procedure
Efficacy: Percent Regression
Efficacy, defined as the regression percentage at the first follow-up endoscopy, after one (1) treatment covering 50% of circumference of the esophagus with the therapeutic dose.
Time frame: 10 weeks
Efficacy: Treatment
Efficacy of treatment with CryoBalloon 180 Ablation system, defined as the proportion of patients with ≥80% regression of BE after 1 hemi-circumferential and after full circumferential treatment.
Time frame: 10 weeks
Post procedure dysphagia score
Post procedure dysphagia score (scored 0-4 dysphagia score), described as median dysphagia score directly
Time frame: 24 hours, 7 days and 30 days post-procedure
Plan to share: No — Data will not be shared.
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Merit Medical Systems, Inc.