CryoSpray Ablation (TM) GI Patient Registry
Study Details
Study Description
Brief Summary
The purpose of this study is to create a patient registry to collect and analyze post-510K approval information on subjects treated endoscopically with the CryoSpray Ablation™ System.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
The proposed registry is a prospective, multi-center study of patients that are being currently undergoing CryoSpray Ablation™. It will also be used to catalogue retrospective data from records of patients already treated with the device. A maximum of 40 investigational sites will participate in this study.
Study Design
Outcome Measures
Primary Outcome Measures
- Primary objectives of the study are to enable analysis of patient outcomes 2 years after final treatment and report on the effectiveness of the device in eradicating, decreasing or downgrading of the lesions. [2 years post treatment]
Eligibility Criteria
Criteria
Inclusion Criteria:
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The study population consists of patients who are being treated, or were treated, with the CryoSpray Ablation™ System for malignant or pre-malignant conditions of the esophagus, including:
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Barrett's esophagus with or without dysplasia
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Squamous dysplasia of the esophagus
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Esophageal cancer, any stage
Exclusion Criteria:
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Subjects with esophageal lesions whose pathology was not one of the above.
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Subjects with one of the above conditions who were not treated with the CryoSpray Ablation™ System.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The Scripps Research Institute | LaJolla | California | United States | 92037 |
| 2 | University of Maryland Medical Center | Baltimore | Maryland | United States | 21201 |
| 3 | Syosset Hospital | Lake Success | New York | United States | 10042 |
| 4 | University of North Carolina-Chapel Hill | Chapel Hill | North Carolina | United States | 27599 |
| 5 | Cleveland Clinic Foundation | Cleveland | Ohio | United States | 44195 |
| 6 | Rhode Island Hospital | Providence | Rhode Island | United States | 02903 |
Sponsors and Collaborators
- CSA Medical, Inc.
Investigators
- Study Director: Ann Murphy Legg, RN, CSA Medical, Inc.
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.
- 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.
- 17-00030