CryoSpray Ablation (TM) GI Patient Registry

CSA Medical

Status: Completed

Conditions: Esophageal Cancer; Barrett's Esophagus

Study type: Observational

Funder types: Industry

Identifiers

NCT00747448

17-00030

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 199 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.