50
Participants
Start Date
January 31, 2015
Primary Completion Date
December 29, 2016
Study Completion Date
October 4, 2017
C2 CryoBalloon Focal Ablation System
"The C2 Focal Cryoablation Device will be used for the treatment of islands of BE in real patient care. Ablation at 10 seconds will be tested and post-ablation symptoms related to the Cryoballoon Focal Ablation will be recorded. At 12 weeks, the patient will receive a follow-up endoscopy and biopsy samples will be taken.~Biopsy samples will be evaluated for the presence of residual Barrett's Esophagus. Through evaluation of the histological results, treatment parameters for the ablation of human esophageal epithelium will be better understood.~Evaluations include, but are not limited to the following:~* Device malfunctions~* Adverse events~* Patient Pain~* Histological evaluation of treatment zone at 12 weeks for presence of residual Barrett's Esophagus."
Academic Medical Center Amsterdam, Amsterdam
St. Antonius Hospital, Nieuwegein
Lead Sponsor
Pentax Medical
INDUSTRY