Study of CryoSpray Ablation of Low Grade or High Grade Dysplasia Within Barrett's Esophagus

Stopped early · Phase 4

Conditions studied: Barrett's Esophagus, High Grade Dysplasia, Low Grade Dysplasia

In brief

The purpose of this study is to evaluate the safety and effectiveness of the CryoSpray Ablation System to treat esophageal low grade dysplasia (LGD) or high grade dysplasia (HGD) within Barrett's Esophagus (BE).

Key facts

Study ID

NCT00526786

Run by

CSA Medical, Inc.

People needed

78

Starts

2007-09-01

Expected to finish

2009-09-01

Last updated by the study team

2014-03-14

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Karnofsky performance status of 50-100%
• 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).

You may not qualify if…

• Pregnant, not practicing adequate contraception, intending to become pregnant, or lactating at any time during the study (approximately 2 years).
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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