CryoSpray Ablation(tm)Thoracic Patient Registry - Full Text View

Purpose

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.

Condition
Lung Cancer Emphysema Chronic Bronchitis COPD Asthma Sarcoidosis Mesothelioma

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:

MedlinePlus related topics: Asthma Cancer Chronic Bronchitis Emphysema Lung Cancer Mesothelioma Sarcoidosis

U.S. FDA Resources

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.

Eligibility

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.

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00785239

Sponsors and Collaborators

CSA Medical, Inc.

Reset Medical, Inc.

Investigators

Principal Investigator:

William Krimsky, M.D.

Franklin Square Hospital Center

More Information

Additional Information:

For more information regarding CryoSpray Ablation This link exits the ClinicalTrials.gov site

Publications:

Johnston MH, Eastone JA, Horwhat JD, Cartledge J, Mathews JS, Foggy JR. Cryoablation of Barrett's esophagus: a pilot study. Gastrointest Endosc. 2005 Dec;62(6):842-8.

Johnston CM, Schoenfeld LP, Mysore JV, Dubois A. Endoscopic spray cryotherapy: a new technique for mucosal ablation in the esophagus. Gastrointest Endosc. 1999 Jul;50(1):86-92.

Ell C, May A, Gossner L, Pech O, Gunter E, Mayer G, Henrich R, Vieth M, Muller H, Seitz G, Stolte M. Endoscopic mucosal resection of early cancer and high-grade dysplasia in Barrett's esophagus. Gastroenterology. 2000 Apr;118(4):670-7.

Champion G, Richter JE, Vaezi MF, Singh S, Alexander R. Duodenogastroesophageal reflux: relationship to pH and importance in Barrett's esophagus. Gastroenterology. 1994 Sep;107(3):747-54.

Eisen GM, Sandler RS, Murray S, Gottfried M. The relationship between gastroesophageal reflux disease and its complications with Barrett's esophagus. Am J Gastroenterol. 1997 Jan;92(1):27-31.

Johnston MH. Cryotherapy and other newer techniques. Gastrointest Endosc Clin N Am. 2003 Jul;13(3):491-504. Review.

Cash BD, Johnston LR, Johnston MH. Cryospray ablation (CSA) in the palliative treatment of squamous cell carcinoma of the esophagus. World J Surg Oncol. 2007 Mar 16;5:34.

Pinsonneault C, Fortier J, Donati F. Tracheal resection and reconstruction. Can J Anaesth. 1999 May;46(5 Pt 1):439-55. Review.

Field JK, Youngson JH. The Liverpool Lung Project: a molecular epidemiological study of early lung cancer detection. Eur Respir J. 2002 Aug;20(2):464-79.

Responsible Party:	Karen McKenzie, Reset Medical, Inc.
ClinicalTrials.gov 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
Emphysema
Chronic Bronchitis
COPD
Asthma

Sarcoidosis
Mesothelioma
CryoSpray Ablation
Cryotherapy
Cryospray
Cryo

Additional relevant MeSH terms:

Asthma
Bronchitis
Bronchitis, Chronic
Emphysema
Pulmonary Emphysema
Pulmonary Disease, Chronic Obstructive
Lung Neoplasms
Mesothelioma
Sarcoidosis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate

Hypersensitivity
Immune System Diseases
Respiratory Tract Infections
Pathologic Processes
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Mesothelial
Lymphoproliferative Disorders
Lymphatic Diseases

ClinicalTrials.gov processed this record on May 22, 2013