CryoSpray Ablation(tm)Thoracic Patient Registry
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- CSA Medical, Inc.
- Primary Endpoint
- 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.
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported