Clinical trial NCT00785239: CryoSpray Ablation(tm)Thoracic Patient Registry
Official title: CryoSpray Ablation(tm)Thoracic Patient Registry
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Lung Cancer
Emphysema
Chronic Bronchitis
COPD
Asthma
Sarcoidosis
Mesothelioma
Keywords: Malignant Airway Disease
Benign Airway Disease
Lung Cancer
Emphysema
Chronic Bronchitis
COPD
Asthma
Sarcoidosis
Mesothelioma
CryoSpray Ablation
Cryotherapy
Cryospray
Cryo
Lead sponsor: CSA Medical, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Reset Medical, Inc.
First posted: 2008-11-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: 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.
timeFrame: 2 years post-treatment
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Franklin Square Hospital Center
name: William Krimsky, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1016/j.gie.2005.05.008.
citation: 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. doi: 10.1016/s0016-5107(99)70352-4.
citation: 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. doi: 10.1016/s0016-5085(00)70136-3.
citation: 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. doi: 10.1016/0016-5085(94)90123-6.
citation: 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.
citation: Johnston MH. Cryotherapy and other newer techniques. Gastrointest Endosc Clin N Am. 2003 Jul;13(3):491-504. doi: 10.1016/s1052-5157(03)00044-8.
citation: 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. doi: 10.1186/1477-7819-5-34.
citation: Pinsonneault C, Fortier J, Donati F. Tracheal resection and reconstruction. Can J Anaesth. 1999 May;46(5 Pt 1):439-55. doi: 10.1007/BF03012943.
citation: 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. doi: 10.1183/09031936.02.00290202.