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Multi-center Clinical Study to Evaluate the C2 CryoBalloon Focal Ablation System
NCT02514525 · View on ClinicalTrials.gov ↗
Study Summary
To evaluate the efficacy and safety of the CryoBalloon Focal Ablation System for the treatment of previously-untreated ("treatment naïve") Barrett's Esophagus (BE)
Conditions Studied
Interventions
- DEVICE CryoBalloon Ablation System
Study Locations (11)
New York
- Northwell Health — Manhasset
- New York Presbyterian Hospital-Columbia University Medical Center — New York
Pennsylvania
- Geisinger Medical Center — Danville
- Thomas Jefferson University — Philadelphia
California
- UC Irvine — Orange
Florida
- Sarasota Memorial Hospital — Sarasota
Illinois
- University of Chicago — Chicago
Maryland
- John Hopkins — Baltimore
Minnesota
- Mayo Clinic — Rochester
North Carolina
- University of North Carolina School of Medicine — Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2016-03 |
| Est. Completion | 2025-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02514525
The ClinicalTrials.gov registry entry for NCT02514525 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Pentax Medical, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Barrett Esophagus appearing as the primary indexed condition, and to 1 intervention — of which CryoBalloon Ablation System is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02514525 reports 11 study locations spanning 9 distinct geographic areas — top geographies include New York, Pennsylvania, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02514525 about?
NCT02514525 is a clinical study titled "Multi-center Clinical Study to Evaluate the C2 CryoBalloon Focal Ablation System". To evaluate the efficacy and safety of the CryoBalloon Focal Ablation System for the treatment of previously-untreated ("treatment naïve") Barrett's Esophagus (BE)
What is the current status of trial NCT02514525?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 150 participants. The study started on 2016-03. Estimated completion is 2025-12.
What conditions does trial NCT02514525 study?
This clinical trial studies the following conditions: Barrett Esophagus. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02514525?
The interventions under investigation include: CryoBalloon Ablation System (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02514525?
This trial is sponsored by Pentax Medical, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02514525 being conducted?
This trial has 11 study locations across California, Florida, Illinois, Maryland, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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