CryoSpray Ablation(tm)Thoracic Patient Registry

Withdrawn

• Conditions: Lung Cancer; Asthma; Sarcoidosis; Chronic Bronchitis; Emphysema; COPD; Mesothelioma

• Registration Number: NCT00785239
• Lead Sponsor: CSA Medical, Inc.

Brief Summary

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

Detailed Description

The proposed registry is a prospective, multi-center study of patients that are currently undergoing CryoSpray Ablation™. A maximum of 50 investigational sites will participate in this study.

The study population consists of patients who are being treated with the CryoSpray Ablation™ System for thoracic diseases. Enrolled subjects must have a signed consent form for data collection.

Study Timeline

• Study First Submitted: 2008-11-04
• Study First Submitted QC: 2008-11-04
• Study First Posted: 2008-11-05
• Study Start: 2009-04
• Primary Completion: 2009-04
• Study Completion: 2009-04
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-23
• Last Update Posted: 2015-06-25

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patients who are being treated with the CryoSpray Ablation™ System for lung and for thoracic diseases.

Exclusion Criteria

• Subjects with thoracic or airway obstructions and diseases who were not treated with the CryoSpray Ablation™ System.
• Subjects under the age of 18 years.
• Subjects unable to provide consent.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary objectives of the study are to enable analysis of patient outcomes 2 years following final treatment and estimate the effectiveness of the device in eradicating, decreasing and downgrading of the diseases.	2 years post-treatment