Evaluation of Balloon-based Cryoablation of Human Esophageal Epithelium

Pentax Medical

Status

Completed

Conditions

Esophageal Cancer

Barrett's Esophagus

Treatments

Device: Cryoballoon Ablation

Study type

Interventional

Funder types

Industry

Identifiers

NCT01293448

CP-0001.A

Details and patient eligibility

About

The purpose of this study is to evaluate a cryoablation technique used to ablate human esophageal mucosa.

Full description

The purpose of this study is to evaluate the histological results of a cryoablation technique used to ablate human esophageal mucosa. The performance and safety of the cryoablation technique will also be evaluated.

Enrollment

21 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient must have a minimum of 2.0 cm of non-ulcerated, non-inflammatory columnar-lined esophagus or squamous esophageal lined tissue suitable for ablation. A patient may be treated with up to 2 zones of ablation.
Patient is 18 to 80 years of age at the time of consent (inclusive).
Patient has provided written Informed Consent Form (IFC) using a form 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's esophagectomy is clinically necessary due to reasons unrelated to this study.
Patient is deemed operable per standard institutional criteria.

Exclusion criteria

Patient has a known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to IFC, post treatment instructions or follow-up guidelines.
Patient refuses or is unable to provide written informed consent. - -
Patient has or is currently undergoing endoscopic ablation therapy within 4 cm from the proposed treatment area including, but not limited to cryospray therapy, laser treatment, photodynamic therapy, multi-polar electro coagulation, endoscopic mucosal resection, radiofrequency ablation or argon plasma coagulation.
Patient has esophageal narrowing limiting access to the intended site of ablation.
Patient is undergoing or has recently undergone chemotherapy (within 15 days or WBC below normal by institutional criteria or standards).
Patient is undergoing or has recently undergone radiation therapy which involved the esophagus (within 15 days or WBC below normal by institutional criteria or standards).