NCT02249975

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Pentax Medical · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the efficacy and performance of the C2 Focal Cryoablation System in patients with BE.

Detailed description

The purpose of this study is to assess the efficacy and performance of the C2 Focal Cryoablation System in patients with BE. The study will involve up to 50 subjects with each subject receiving cryoablation therapy of all visible BE using the C2 System Focal Ablation System. Length of ablation will be 10 seconds. The ablations will be performed on Barrett's epithelium with a maximal length of 6 cm. At the time of endoscopic follow up, biopsies of the treated area will be taken and submitted for analysis according to Histopathology Protocol. This study is: * Prospective * Multi-center * Non-randomized

Conditions

• Barrett's Esophagus

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2015-01-01
• Primary completion: 2016-12-29
• Completion: 2017-10-04
• First posted: 2014-09-26
• Last updated: 2022-04-28

Locations

2 sites across 1 country: Netherlands