CryoSpray Ablation(tm)Thoracic Patient Registry
Study Details
Study Description
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.
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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
Outcome Measures
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. [2 years post-treatment]
Eligibility Criteria
Criteria
Inclusion Criteria:
Patients who are being treated with the CryoSpray Ablation™ System for lung and for thoracic diseases.
Exclusion Criteria:
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Subjects with thoracic or airway obstructions and diseases who were not treated with the CryoSpray Ablation™ System.
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Subjects under the age of 18 years.
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Subjects unable to provide consent.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- CSA Medical, Inc.
- Reset Medical, Inc.
Investigators
- Principal Investigator: William Krimsky, M.D., Franklin Square Hospital Center
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- Ell C, May A, Gossner L, Pech O, Günter E, Mayer G, Henrich R, Vieth M, Müller 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.
- 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.
- 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.
- 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 MH. Cryotherapy and other newer techniques. Gastrointest Endosc Clin N Am. 2003 Jul;13(3):491-504. Review.
- Pinsonneault C, Fortier J, Donati F. Tracheal resection and reconstruction. Can J Anaesth. 1999 May;46(5 Pt 1):439-55. Review.
- 17-00031