Study Results
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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COMPLETED
199 participants
OBSERVATIONAL
2009-05-31
2013-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
Eligibility Criteria
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Inclusion Criteria
* Barrett's esophagus with or without dysplasia
* Squamous dysplasia of the esophagus
* Esophageal cancer, any stage
Exclusion Criteria
* Subjects with one of the above conditions who were not treated with the CryoSpray Ablation™ System.
18 Years
ALL
No
Sponsors
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CSA Medical, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Ann Murphy Legg, RN
Role: STUDY_DIRECTOR
CSA Medical, Inc.
Locations
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The Scripps Research Institute
La Jolla, California, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Syosset Hospital
Lake Success, New York, United States
University of North Carolina-Chapel Hill
Chapel Hill, North Carolina, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Countries
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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.
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.
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.
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.
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. doi: 10.1016/s1052-5157(03)00044-8.
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.
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.
Other Identifiers
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17-00030
Identifier Type: -
Identifier Source: org_study_id
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