Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

CryoSpray Ablation(tm)Thoracic Patient Registry

This study has been withdrawn prior to enrollment.
(Business Reasons)
Reset Medical, Inc.
Information provided by:
CSA Medical, Inc. Identifier:
First received: November 4, 2008
Last updated: May 27, 2009
Last verified: May 2009

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.

Lung Cancer
Chronic Bronchitis

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: CryoSpray Ablation(tm)Thoracic Patient Registry

Resource links provided by NLM:

Further study details as provided by CSA Medical, Inc.:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 500
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)
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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.


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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00785239

Sponsors and Collaborators
CSA Medical, Inc.
Reset Medical, Inc.
Principal Investigator: William Krimsky, M.D. Franklin Square Hospital Center
  More Information

Additional Information:

Responsible Party: Karen McKenzie, Reset Medical, Inc. Identifier: NCT00785239     History of Changes
Other Study ID Numbers: 17-00031
Study First Received: November 4, 2008
Last Updated: May 27, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by CSA Medical, Inc.:
Malignant Airway Disease
Benign Airway Disease
Lung Cancer
Chronic Bronchitis
CryoSpray Ablation

Additional relevant MeSH terms:
Bronchitis, Chronic
Bronchial Diseases
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Respiratory Tract Infections processed this record on March 03, 2015