CryoSpray Ablation (TM) GI Patient Registry - Full Text View

Sponsor:	CSA Medical, Inc.
Information provided by:	CSA Medical, Inc.
ClinicalTrials.gov Identifier:	NCT00747448

Purpose

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
Barrett's Esophagus With or Without Dysplasia Squamous Dysplasia of the Esophagus Esophageal Cancer (Any Stage)

Study Type:	Observational
Study Design:	Observational Model: Case-Only
Official Title:	CryoSpray Ablation (TM) GI Patient Registry

Resource links provided by NLM:

MedlinePlus related topics: Cancer Esophageal Cancer Esophagus Disorders

U.S. FDA Resources

Further study details as provided by CSA Medical, Inc.:

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. [ Time Frame: 2 years post treatment ] [ Designated as safety issue: No ]

Estimated Enrollment:	500
Study Start Date:	May 2009
Estimated Study Completion Date:	December 2014
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

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, as evidenced by histology.

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00747448

Contacts

Contact: Karen McKenzie	443-524-9673	kmckenzie@csamedical.com
Contact: Ebony Wiggins	443-524-9682	ewiggins@csamedical.com

Locations

United States, California
The Scripps Research Institute	Recruiting
LaJolla, California, United States, 92037
Contact: Patricia Dineen 858-605-7367 Dineen.Patricia@scrippshealth.org
Contact: Franklin C Tsai, M.D. Tsai.Franklin@scrippshealth.org
Principal Investigator: Walter J. Coyle, M.D.
Sub-Investigator: Franklin C. Tsai, M.D.
United States, Maryland
University of Maryland Medical Center	Recruiting
Baltimore, Maryland, United States, 21201
Contact: Andrea Waldt, R.N. 410-328-8731 awaldt@medicine.umaryland.edu
Principal Investigator: Bruce Greenwald, M.D.
United States, New York
Syosset Hospital	Recruiting
Lake Success, New York, United States, 10042
Contact: Kim Gallub, R.N. 516-622-6145 ksharvin@ProHEALTHcare.com
Principal Investigator: Matthew McKinley, M.D.
United States, North Carolina
University of North Carolina-Chapel Hill	Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Melissa Spacek 919-966-7780 Melissa_Brennen@med.unc.edu
Principal Investigator: Nicholas Shaheen, MD, PhD
United States, Ohio
Cleveland Clinic Foundation	Recruiting
Cleveland, Ohio, United States, 44195
Contact: Christine Bodnar, BSA, CCRP 216-444-8524 BODNARC@ccf.org
Contact: Mary Oldenburgh 216-444-8524 OLDENBM@ccf.org
Principal Investigator: John Dumot, D.O.
Sub-Investigator: Gary Falk, M.D.
Sub-Investigator: John Vargo, M.D.
United States, Rhode Island
Rhode Island Hospital	Recruiting
Providence, Rhode Island, United States, 02903
Contact: Jan Clark 401-444-7344 JClark3@Lifespan.org
Principal Investigator: Fadlallah Habr, MD

Sponsors and Collaborators

CSA Medical, Inc.

Investigators

Study Director:

Paul Manburg, PhD

CSA Medical, Inc.

More Information

Additional Information:

This website shows the CryoSpray Ablation (tm) System and explains the procedures. This link exits the ClinicalTrials.gov site

Publications:

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 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.

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.

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.

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

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.

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

Responsible Party:	Karen McKenzie / Clinical and Validations Program Manager, CSA Medical, Inc.
ClinicalTrials.gov Identifier:	NCT00747448 History of Changes
Other Study ID Numbers:	17-00030
Study First Received:	September 4, 2008
Last Updated:	January 24, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by CSA Medical, Inc.:

Barrett's Esophagus
High Grade Dysplasia
Low Grade Dysplasia
Squamous Dysplasia

Esophageal Cancer
CryoSpray Ablation
Cryotherapy
Cryospray

Additional relevant MeSH terms:

Barrett Esophagus
Esophageal Diseases
Esophageal Neoplasms
Hyperplasia
Digestive System Abnormalities
Digestive System Diseases
Gastrointestinal Diseases

Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Pathologic Processes

ClinicalTrials.gov processed this record on February 09, 2012