CryoSpray Ablation (TM) GI Patient Registry

Status:	Completed
Conditions:	Cancer, Cancer, Gastrointestinal, Hematology
Therapuetic Areas:	Gastroenterology, Hematology, Oncology
Healthy:	No
Age Range:	18 - Any
Updated:	4/21/2016
Start Date:	May 2009
End Date:	June 2013

The purpose of this study is to create a patient registry to collect and analyze post-510K
approval information on subjects treated endoscopically with the CryoSpray Ablation™ System.

The proposed registry is a prospective, multi-center study of patients that are being
currently undergoing CryoSpray Ablation™. It will also be used to catalogue retrospective
data from records of patients already treated with the device. A maximum of 40
investigational sites will participate in this study.

Inclusion Criteria:

- The study population consists of patients who are being treated, or were treated,
with the CryoSpray Ablation™ System for malignant or pre-malignant conditions of the
esophagus, including:

- Barrett's esophagus with or without dysplasia

- Squamous dysplasia of the esophagus

- Esophageal cancer, any stage

Exclusion Criteria:

- Subjects with esophageal lesions whose pathology was not one of the above.

- Subjects with one of the above conditions who were not treated with the CryoSpray
Ablation™ System.

We found this trial at

sites

Rhode Island Hospital

593 Eddy Street
Providence, Rhode Island 02903

401-444-4000