Multi-center Clinical Study to Evaluate the C2 CryoBalloon Focal Ablation System

NAActive, not recruitingINTERVENTIONAL
Enrollment

150

Participants

Timeline

Start Date

March 31, 2016

Primary Completion Date

March 31, 2024

Study Completion Date

December 31, 2025

Conditions
Barrett Esophagus
Interventions
DEVICE

CryoBalloon Ablation System

CryoBalloon Ablation System, a balloon-based cryotherapy device, provides controlled ablation for the treatment of BE. Deployed through the working channel of an endoscope, the Balloon is simultaneously inflated and cooled with an inert cryogen (nitrous oxide) delivered from the handle that ablates the BE cells upon contact with the esophagus.

Trial Locations (11)

10032

New York Presbyterian Hospital-Columbia University Medical Center, New York

11030

Northwell Health, Manhasset

17822

Geisinger Medical Center, Danville

19107

Thomas Jefferson University, Philadelphia

21205

John Hopkins, Baltimore

27599

University of North Carolina School of Medicine, Chapel Hill

34239

Sarasota Memorial Hospital, Sarasota

44106

University Hospitals Cleveland Medical Center, Cleveland

55905

Mayo Clinic, Rochester

60637

University of Chicago, Chicago

92868

UC Irvine, Orange

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pentax Medical

INDUSTRY

NCT02514525 - Multi-center Clinical Study to Evaluate the C2 CryoBalloon Focal Ablation System | Biotech Hunter | Biotech Hunter