Clinical trial NCT00526786: Study of CryoSpray Ablation of Low Grade or High Grade Dysplasia Within Barrett's Esophagus
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)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Barrett's Esophagus
High Grade Dysplasia
Low Grade Dysplasia
Keywords: Low Grade Dysplasia
High Grade Dysplasia
Barrett's Esophagus
Cryospray ablation
ICE
Cryotherapy
Cryo
CryoSpray
Lead sponsor: CSA Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2007-09-10
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: 2 years post treatment
Secondary outcomes:
measure: 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.
timeFrame: 2 years post treatment
Other outcomes:
Locations:
city: Orange
country: United States
facility: University of California -Irvine
state: California
city: Norwalk
country: United States
facility: Norwalk Hospital
state: Connecticut
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center
state: Florida
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
city: Hoboken
country: United States
facility: Hoboken Universtiy Medical Center
state: New Jersey
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Chapel Hill
country: United States
facility: Universtiy of North Carloina at Chapel Hill
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Lancaster
country: United States
facility: Lancaster Reginal Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Dallas
country: United States
facility: Baylor University
state: Texas
Study officials:
affiliation: University of Maryland
name: Bruce Greenwald, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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. doi: 10.1016/0016-5085(94)90123-6.
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.
citation: 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.
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. doi: 10.1016/s0016-5107(99)70352-4.
citation: 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.
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. doi: 10.1016/j.gie.2005.05.008.