Study of CryoSpray Ablation of Low Grade or High Grade Dysplasia Within Barrett's Esophagus (ICE)
Primary Purpose
Barrett's Esophagus, High Grade Dysplasia, Low Grade Dysplasia
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
CryoSpray Ablation System (510(k) NO: K070893)
Sponsored by
About this trial
This is an interventional treatment trial for Barrett's Esophagus focused on measuring Low Grade Dysplasia, High Grade Dysplasia, Barrett's Esophagus, Cryospray ablation, ICE, Cryotherapy, Cryo, CryoSpray
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.
Sites / Locations
- University of California -Irvine
- Norwalk Hospital
- H. Lee Moffitt Cancer Center
- University of Maryland Medical Center
- Boston Medical Center
- Beth Israel Deaconess Medical Center
- Hoboken Universtiy Medical Center
- Columbia University Medical Center
- Universtiy of North Carloina at Chapel Hill
- Duke University Medical Center
- Cleveland Clinic Foundation
- Lancaster Reginal Medical Center
- Thomas Jefferson University Hospital
- University of Pittsburgh Medical Center
- Rhode Island Hospital
- Baylor University
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00526786
Brief Title
Study of CryoSpray Ablation of Low Grade or High Grade Dysplasia Within Barrett's Esophagus
Acronym
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)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Terminated
Why Stopped
Business Reasons
Study Start Date
September 2007 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CSA Medical, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
78 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
CryoSpray Ablation System (510(k) NO: K070893)
Other Intervention Name(s)
510(k) NO: K070893
Intervention Description
no drug interventions specified
Primary Outcome Measure Information:
Title
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.
Time Frame
2 years post treatment
Secondary Outcome Measure Information:
Title
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.
Time Frame
2 years post treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce Greenwald, M.D.
Organizational Affiliation
University of Maryland
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California -Irvine
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Norwalk Hospital
City
Norwalk
State/Province
Connecticut
ZIP/Postal Code
06856
Country
United States
Facility Name
H. Lee Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Hoboken Universtiy Medical Center
City
Hoboken
State/Province
New Jersey
ZIP/Postal Code
07030
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Universtiy of North Carloina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27708
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Lancaster Reginal Medical Center
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17604
Country
United States
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Baylor University
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
8076761
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.
Results Reference
background
PubMed Identifier
8995932
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.
Results Reference
background
PubMed Identifier
10734018
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.
Results Reference
background
PubMed Identifier
10385730
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.
Results Reference
background
PubMed Identifier
14629105
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.
Results Reference
background
PubMed Identifier
16301023
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.
Results Reference
background
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Study of CryoSpray Ablation of Low Grade or High Grade Dysplasia Within Barrett's Esophagus
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