Asthma, Chronic Bronchitis, COPD, Emphysema, Lung Cancer, Mesothelioma, Sarcoidosis
Conditions
Keywords
Malignant Airway Disease, Benign Airway Disease, Lung Cancer, Emphysema, Chronic Bronchitis, COPD, Asthma, Sarcoidosis, Mesothelioma, CryoSpray Ablation, Cryotherapy, Cryospray, Cryo
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.
Interventions
None listed
Sponsors
Reset Medical, Inc.
CSA Medical, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Outcome results
None listed