Evaluation of Balloon-based Focal Cryoablation of Human Esophageal Epithelium

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 29

Inclusion Criteria

a) Patients with known high grade dysplasia or early adenocarcinoma in BE.
b) Patients scheduled for ablation- and/or EMR-therapy gastroscopies, during which cryoablation may be performed.
c) Patient is 18 to 80 years of age at the time of consent (inclusive).
d) Patient has provided written Informed Consent (IC) using an Informed Consent Form (ICF) that has been approved by the Institution*s reviewing IRB/EC.
e) Patient is willing and able to comply with all Clinical Investigation Plan (CIP) requirements.
f) Patient is deemed operable per standard institutional criteria.
g) Each patient has a C&M classification of C*2 and/or M*3.
h) Each patient will have one area of BE or one island of BE >1 cm2 where the Cryoballoon Focal Ablation System can be successfully positioned within the BE lesion. Cryoballoon ablation should be performed within 1 cm of the proximal border of the Barrett*s epithelium.
i) BE lesion within the treatment zone should be flat.

Exclusion Criteria

a) Patient with endoscopically active inflammation in the treatment zone
b) Esophageal stenosis preventing advancement of a therapeutic endoscope and/or within 4 cm of treatment zone.
c) Patient has a known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to informed consent, post treatment instructions or follow-up guidelines.
d) Patient refuses or is unable to provide written informed consent.
e) Patients that received prior treatment with any energy-based ablation system.
f) Endoscopically visible abnormalities such as masses or nodules within 4 cm of the treatment zone.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1) Performance of the balloon-based focal cryoablation system<br /><br>2) Adverse events by using the balloon-based focal cryoablation system<br /><br>3) Esophageal stricture formation and assessment of clinical dysphagia after<br /><br>using the balloon-based focal cryoablation system</p><br>

Secondary Outcome Measures