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CryoSpray Ablation(tm)Thoracic Patient Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00785239
Recruitment Status : Withdrawn (Business Reasons)
First Posted : November 5, 2008
Last Update Posted : June 25, 2015
Sponsor:
Collaborator:
Reset Medical, Inc.
Information provided by (Responsible Party):
CSA Medical, Inc.

Tracking Information
First Submitted Date November 4, 2008
First Posted Date November 5, 2008
Last Update Posted Date June 25, 2015
Study Start Date April 2009
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 4, 2008)
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 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title CryoSpray Ablation(tm)Thoracic Patient Registry
Official Title CryoSpray Ablation(tm)Thoracic Patient Registry
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 Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population The study population consists of subjects treated with the CryoSpray Ablation™ System in the airway or for thoracic diseases.
Condition
  • Lung Cancer
  • Emphysema
  • Chronic Bronchitis
  • COPD
  • Asthma
  • Sarcoidosis
  • Mesothelioma
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Withdrawn
Actual Enrollment
 (submitted: April 27, 2015)
0
Original Estimated Enrollment
 (submitted: November 4, 2008)
500
Actual Study Completion Date April 2009
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT00785239
Other Study ID Numbers 17-00031
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party CSA Medical, Inc.
Study Sponsor CSA Medical, Inc.
Collaborators Reset Medical, Inc.
Investigators
Principal Investigator: William Krimsky, M.D. Franklin Square Hospital Center
PRS Account CSA Medical, Inc.
Verification Date June 2015