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

Barrett's Esophagus Clinical Trial

— ICE  

Official title:

A Prospective, Multi-center, Longitudinal Cohort Study of CryoSpray Ablation of Low Grade or High Grade Dysplasia Within Barrett's Esophagus (LCS Dysplasia)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00526786
• Other study ID #: 16-00016-00
• Status: Terminated
• Phase: Phase 4
• First received: September 5, 2007
• Last updated: March 12, 2014
• Start date: September 2007
• Est. completion date: September 2009

Study information

• Verified date: March 2014
• Source: CSA Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Description:

The study will consist of an estimated 200 subjects with HGD or LGD within BE who are deemed inoperable or refuse standard surgical treatment. A maximum of 20 investigational sites will participate with a maximum of ten subjects per site.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 78
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Barrett Esophagus
• Barrett's Esophagus
• High Grade Dysplasia
• Hyperplasia
• Low Grade Dysplasia

Intervention

Device:
• CryoSpray Ablation System (510(k) NO: K070893)
no drug interventions specified

Locations

Country	Name	City	State
United States	University of Maryland Medical Center	Baltimore	Maryland
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Boston Medical Center	Boston	Massachusetts
United States	Universtiy of North Carloina at Chapel Hill	Chapel Hill	North Carolina
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Baylor University	Dallas	Texas
United States	Duke University Medical Center	Durham	North Carolina
United States	Hoboken Universtiy Medical Center	Hoboken	New Jersey
United States	Lancaster Reginal Medical Center	Lancaster	Pennsylvania
United States	Columbia University Medical Center	New York	New York
United States	Norwalk Hospital	Norwalk	Connecticut
United States	University of California -Irvine	Orange	California
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	H. Lee Moffitt Cancer Center	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
CSA Medical, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (6)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The eradication of LGD and HGD within BE at 24 months after the final treatment. The primary safety endpoint is the incidence of all adverse events.		2 years post treatment
Secondary	1.Eradication of all BE by 24 months after the final treatment. 2.The proportion of lesions that decreased in length by the 24-month follow-up. 3.The proportion of lesions where severity was downgraded by the 24-month follow-up.		2 years post treatment

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