CryoSpray Ablation(tm)Thoracic Patient Registry
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.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||CryoSpray Ablation(tm)Thoracic Patient Registry|
- 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. [ Time Frame: 2 years post-treatment ] [ Designated as safety issue: No ]
|Study Start Date:||June 2009|
|Estimated Study Completion Date:||November 2012|
|Estimated Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00785239
|Principal Investigator:||William Krimsky, M.D.||Franklin Square Hospital Center|