🏛️ Verified NIH Record • Updated 2025-01-09
Multi-center Clinical Study to Evaluate the C2 CryoBalloon Focal Ablation System (NCT02514525)
Multi-center Clinical Study to Evaluate the C2 CryoBalloon Focal Ablation System for the Treatment of Patients With Previously Untreated Dysplastic Barrett's Epithelium
🔵 Active, Not Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: Pentax Medical
🩺 Plain-English Summary (8th-Grade Level)
To evaluate the efficacy and safety of the CryoBalloon Focal Ablation System for the treatment of previously-untreated ("treatment naïve") Barrett's Esophagus (BE)
Who can join: Review the eligibility criteria below.
Location: UC Irvine — Orange, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (11 Sites)
- UC Irvine — Orange, California
- Sarasota Memorial Hospital — Sarasota, Florida
- University of Chicago — Chicago, Illinois
- John Hopkins — Baltimore, Maryland
- Mayo Clinic — Rochester, Minnesota
- Northwell Health — Manhasset, New York
- New York Presbyterian Hospital-Columbia University Medical Center — New York, New York
- University of North Carolina School of Medicine — Chapel Hill, North Carolina
- University Hospitals Cleveland Medical Center — Cleveland, Ohio
- Geisinger Medical Center — Danville, Pennsylvania
- Thomas Jefferson University — Philadelphia, Pennsylvania
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Barrett Esophagus
- Novel Biomarkers in the Neoplastic Progression of Barrett's Esophagus — Baltimore, Maryland
- Coordinating Center: Natural History of Barrett's Esophagus Using Tethered Capsule Endomicroscopy — Jacksonville, Florida
- Nitrous Oxide For Endoscopic Ablation of Refractory Barrett's Esophagus (NO FEAR-BE) — Birmingham, Alabama
- Natural History of Barrett's Esophagus Using Tethered Capsule Endomicroscopy — Boston, Massachusetts
- Aspirin in Preventing Disease Recurrence in Patients With Barrett Esophagus After Successful Elimination by Radiofrequency Ablation — Los Angeles, California
Explore by condition: All Barrett Esophagus clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.