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NCT00747448 Clinical Trial

CryoSpray Ablation (TM) GI Patient Registry

Esophageal Cancer Clinical Trial

Official title:
CryoSpray Ablation (TM) GI Patient Registry

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00747448
Other study ID # 17-00030
Secondary ID
Status Completed
Phase N/A
First received September 4, 2008
Last updated February 1, 2016
Start date May 2009
Est. completion date June 2013

Study information
Verified date February 2016
Source CSA Medical, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 199
Est. completion date June 2013
Est. primary completion date June 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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:

- Barrett's esophagus with or without dysplasia

- Squamous dysplasia of the esophagus

- Esophageal cancer, any stage

Exclusion Criteria:

- Subjects with esophageal lesions whose pathology was not one of the above.

- Subjects with one of the above conditions who were not treated with the CryoSpray Ablation™ System.

Study Design

Observational Model: Case-Only

Related Conditions & MeSH terms

Locations
Country Name City State
United States University of Maryland Medical Center Baltimore Maryland
United States University of North Carolina-Chapel Hill Chapel Hill North Carolina
United States Cleveland Clinic Foundation Cleveland Ohio
United States The Scripps Research Institute LaJolla California
United States Syosset Hospital Lake Success New York
United States Rhode Island Hospital Providence Rhode Island

Sponsors (1)
Lead Sponsor Collaborator
CSA Medical, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (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. — View 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. — View 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. — View Citation

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. — View 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. — View 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. — View Citation

Johnston MH. Cryotherapy and other newer techniques. Gastrointest Endosc Clin N Am. 2003 Jul;13(3):491-504. Review. — View Citation

Pinsonneault C, Fortier J, Donati F. Tracheal resection and reconstruction. Can J Anaesth. 1999 May;46(5 Pt 1):439-55. Review. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary 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 No
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