39
Participants
Start Date
December 31, 2011
Primary Completion Date
May 31, 2014
Study Completion Date
June 30, 2014
Focal Cryoballoon Ablation System - 6 seconds
"Ablation of Barrett's Esophagus using a Focal Cryoballoon ablation catheter. The System is a Class II device intended to be used as a cryosurgical tool for the destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications."
Focal Cryoballoon Ablation System - 8 seconds
"Ablation of Barrett's Esophagus using a Focal Cryoballoon ablation catheter. The System is a Class II device intended to be used as a cryosurgical tool for the destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications."
CryoBalloon Focal Ablation System - 10 seconds
"Ablation of Barrett's Esophagus using the Focal CryoBalloon Ablation System. The System is a Class II device intended to be used as a cryosurgical tool for the destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications."
Columbia Medical Center, New York
University of Rochester, Rochester
Allegheny-Singer Research Institute, Pittsburgh
John Hopkins, Baltimore
University of Southern California, Los Angeles
Academic Medical Center Amsterdam, Amsterdam
St. Antonius Hospital, Nieuwegein
Universitair Medisch Centrum Utrecht, Utrecht
Lead Sponsor
Pentax Medical
INDUSTRY