Efficacy of CryoBalloon Focal Ablation System on Human Esophageal Barrett's Epithelium

NACompletedINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

January 31, 2015

Primary Completion Date

December 29, 2016

Study Completion Date

October 4, 2017

Conditions
Barrett's Esophagus
Interventions
DEVICE

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."

Trial Locations (2)

Unknown

Academic Medical Center Amsterdam, Amsterdam

St. Antonius Hospital, Nieuwegein

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Pentax Medical

INDUSTRY

NCT02249975 - Efficacy of CryoBalloon Focal Ablation System on Human Esophageal Barrett's Epithelium | Biotech Hunter | Biotech Hunter