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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 Ablationâ„¢ System.
The proposed registry is a prospective, multi-center study of patients that are being currently undergoing CryoSpray Ablationâ„¢. 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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
The study population consists of patients who are being treated, or were treated, with the CryoSpray Ablationâ„¢ System for malignant or pre-malignant conditions of the esophagus, including:
Exclusion Criteria:
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The study population consists of patients who are being treated, or were treated, with the CryoSpray Ablationâ„¢ System for malignant or pre-malignant conditions of the esophagus, including:
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| Name | Affiliation | Role |
|---|---|---|
| Ann Murphy Legg, RN | CSA Medical, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Scripps Research Institute | La Jolla | California | 92037 | United States | ||
| University of Maryland Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16301023 | Background | 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. | |
| 10385730 | Background | 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. |
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| ID | Term |
|---|---|
| D001471 | Barrett Esophagus |
| D004938 | Esophageal Neoplasms |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| Baltimore |
| Maryland |
| 21201 |
| United States |
| Syosset Hospital | Lake Success | New York | 10042 | United States |
| University of North Carolina-Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| 10734018 | Background | 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. |
| 8076761 | Background | 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. |
| 8995932 | Background | 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. |
| 14629105 | Background | 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. |
| 17367523 | Background | 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. |
| 10349923 | Background | 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. |
| D004066 |
| Digestive System Diseases |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D006258 | Head and Neck Neoplasms |