CryoBalloon Ablation for Barrett's Esophagus
(ColdPlayIII Trial)

Recruiting in Palo Alto (17 mi)

+10 other locations

Overseen byMarcia Canto, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Pentax Medical

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?To evaluate the efficacy and safety of the CryoBalloon Focal Ablation System for the treatment of previously-untreated ("treatment naïve") Barrett's Esophagus (BE)

Eligibility Criteria

This trial is for adults over 18 with Barrett's Esophagus (BE) that hasn't been treated before. Participants must be able to follow the study plan and have BE confirmed by lab tests, without large hiatal hernias or esophageal varices. They can't join if they have uncontrolled bleeding disorders, severe narrowing of the esophagus, extensive cancer history beyond early stage, active severe inflammation of the esophagus, or are pregnant.

Inclusion Criteria

Provides written informed consent on the approved informed consent form

Willing and able to comply with study requirements for follow-up

My Barrett's Esophagus has not been treated and was confirmed by a tissue analysis.

+3 more

Exclusion Criteria

I have had swollen veins in my esophagus.

Severe medical comorbidities precluding endoscopy

Pregnant or planning to become pregnant during period of study participation

+13 more

Participant Groups

The CryoBalloon Focal Ablation System is being tested for its effectiveness and safety in treating Barrett's Esophagus. This device freezes affected tissue to remove it. The study involves people who haven't had previous treatments for their condition and will track how well they respond to this new method.

1Treatment groups

Experimental Treatment

Group I: CryoBalloon Ablation SystemExperimental Treatment1 Intervention

Cryoablation treatment of patients with previously untreated (treatment naïve) Barrett's epithelium.

CryoBalloon Focal Ablation System is already approved in European Union, United States, China for the following indications:

🇪🇺 Approved in European Union as C2 CryoBalloon Ablation System for:

Ablation of unwanted tissue in the gastrointestinal tract, including treatment of Barrett’s Esophagus and squamous dysplasia with application of extreme cold

🇺🇸 Approved in United States as C2 CryoBalloon Ablation System for: