Study of CryoSpray Ablation of Low Grade or High Grade Dysplasia Within Barrett's Esophagus
NCT ID: NCT00526786
Last Updated: 2014-03-14
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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TERMINATED
PHASE4
78 participants
INTERVENTIONAL
2007-09-30
2009-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Interventions
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CryoSpray Ablation System (510(k) NO: K070893)
no drug interventions specified
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Life expectancy greater than 5 years
* Hematopoietic, Hepatic and Renal lab clearance
* Previous endoscopy with histological confirmation of LGD or HGD within BE
* For Group 2, deemed inoperable based on the following criteria: co-morbid conditions such as severe heart, lung, kidney or liver disease; or refusal of surgical intervention after a thorough unbiased discussion of surgery.
* For Group 2, endoscopic ultrasound (EUS) evaluation demonstrating no evidence of invasion or metastatic lymph node involvement (T0N0M0 by EUS).
Exclusion Criteria
* Esophageal stricture preventing passage of endoscope or catheter.
* Active esophagitis
* EMR performed less than 8 weeks prior to CSA treatment.
* EMR performed on greater than 90% circumference of any area of the esophagus.
* Any previous esophageal surgery, except fundoplication without complications.
* Known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to informed consent, post-treatment instructions, or follow-up guidelines.
* Concurrent enrollment in an investigational drug or device trial that clinically interferes with the LCS Dysplasia endpoints.
* Psychiatric or other illness deemed by the investigator as an inability to comply with this protocol.
* Medically unfit or other contraindication to tolerate upper endoscopy.
* Inability to tolerate therapy with a proton pump inhibitor (PPI).
* Refusal or inability to give consent.
* Other active malignancy (except nonmelanoma skin cancer or another cancer for which patient is deemed disease-free).
* Concurrent chemotherapy.
* Prior radiation therapy which involved the esophagus.
* Prior adenocarcinoma involving the esophagus or stomach.
* Prior or concurrent ablation therapy including, but not limited to, photodynamic therapy, multipolar electro coagulation, argon plasma coagulation, laser treatment, radio frequency, etc.
18 Years
85 Years
ALL
No
Sponsors
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CSA Medical, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Bruce Greenwald, M.D.
Role: PRINCIPAL_INVESTIGATOR
University of Maryland
Locations
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University of California -Irvine
Orange, California, United States
Norwalk Hospital
Norwalk, Connecticut, United States
H. Lee Moffitt Cancer Center
Tampa, Florida, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Boston Medical Center
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Hoboken Universtiy Medical Center
Hoboken, New Jersey, United States
Columbia University Medical Center
New York, New York, United States
Universtiy of North Carloina at Chapel Hill
Chapel Hill, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Lancaster Reginal Medical Center
Lancaster, Pennsylvania, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Baylor University
Dallas, Texas, United States
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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16-00016-00
Identifier Type: -
Identifier Source: org_study_id
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