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

Pentax Medical

Status

Completed

Conditions

Barrett's Esophagus

Treatments

Device: C2 CryoBalloon Focal Ablation System

Study type

Interventional

Funder types

Industry

Identifiers

NCT02249975

CP-0004.A

Details and patient eligibility

About

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

Full 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

Enrollment

50 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Criteria Inclusion Criteria

Patients with known Barrett's esophagus, with an indication for ablation therapy during which the cryoablation may be performed.
Patient is 18 to 80 years of age at the time of consent (inclusive).
Patient has provided written Informed Consent (IC) using an Informed Consent Form (ICF) that has been approved by the Institution's reviewing IRB/EC.
Patient is willing and able to comply with all Clinical Investigation Plan (CIP) requirements.
Patient is deemed operable per standard institutional criteria.
BE lesion length <6cm excluding visible BE islands, and Prague Classification C ≥ 0 / M ≥ 0.
One of the following: Flat LGD, Flat HGD, Residual BE after EMR for visible lesions (containing any degree of dysplasia or low-risk early adenocarcinoma (i.e.: not poorly differentiated, negative vertical (deep) resection margins, absence of (lympho)vascular invasion), Residual BE after a single circumferential RFA (performed for indications listed above: i-iii)
BE lesion within the treatment zone should be flat

Exclusion Criteria

Esophageal stenosis preventing advancement of a therapeutic endoscope within 4 cm of treatment zone.
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.
Patient refuses or is unable to provide written informed consent.
Patients that are pregnant.
Patient with endoscopically active inflammation in the treatment zone.
Endoscopically visible abnormalities such as masses or nodules requiring endoscopic resection.