CryoSpray Ablation(tm)Thoracic Patient Registry

NCT ID: NCT00785239

Last Updated: 2015-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2009-04-30

Study Completion Date

2009-04-30

Brief Summary

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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

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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.

Conditions

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Lung Cancer Emphysema Chronic Bronchitis COPD Asthma Sarcoidosis Mesothelioma

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Reset Medical, Inc.

INDUSTRY

Sponsor Role collaborator

CSA Medical, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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William Krimsky, M.D.

Role: PRINCIPAL_INVESTIGATOR

Franklin Square Hospital Center

References

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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.

Reference Type BACKGROUND
PMID: 16301023 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10385730 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10734018 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8076761 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8995932 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14629105 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17367523 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10349923 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12212983 (View on PubMed)

Other Identifiers

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17-00031

Identifier Type: -

Identifier Source: org_study_id

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