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

This study has been terminated.
(Business Reasons)
Sponsor:
Information provided by (Responsible Party):
CSA Medical, Inc.
ClinicalTrials.gov Identifier:
NCT00526786
First received: September 5, 2007
Last updated: March 12, 2014
Last verified: March 2014
  Purpose

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).


Condition Intervention Phase
Barrett's Esophagus
High Grade Dysplasia
Low Grade Dysplasia
Device: CryoSpray Ablation System (510(k) NO: K070893)
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Further study details as provided by CSA Medical, Inc.:

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. [ Time Frame: 2 years post treatment ] [ Designated as safety issue: Yes ]

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. [ Time Frame: 2 years post treatment ] [ Designated as safety issue: No ]

Enrollment: 78
Study Start Date: September 2007
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: CryoSpray Ablation System (510(k) NO: K070893)
    no drug interventions specified
    Other Name: 510(k) NO: K070893
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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00526786

Locations
United States, California
University of California -Irvine
Orange, California, United States, 92868
United States, Connecticut
Norwalk Hospital
Norwalk, Connecticut, United States, 06856
United States, Florida
H. Lee Moffitt Cancer Center
Tampa, Florida, United States, 33612
United States, Maryland
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Boston Medical Center
Boston, Massachusetts, United States, 02118
United States, New Jersey
Hoboken Universtiy Medical Center
Hoboken, New Jersey, United States, 07030
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
United States, North Carolina
Universtiy of North Carloina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Duke University Medical Center
Durham, North Carolina, United States, 27708
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
Lancaster Reginal Medical Center
Lancaster, Pennsylvania, United States, 17604
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
United States, Texas
Baylor University
Dallas, Texas, United States, 75246
Sponsors and Collaborators
CSA Medical, Inc.
Investigators
Principal Investigator: Bruce Greenwald, M.D. University of Maryland
  More Information

Additional Information:
Publications:
Responsible Party: CSA Medical, Inc.
ClinicalTrials.gov Identifier: NCT00526786     History of Changes
Other Study ID Numbers: 16-00016-00
Study First Received: September 5, 2007
Last Updated: March 12, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by CSA Medical, Inc.:
Low Grade Dysplasia
High Grade Dysplasia
Barrett's Esophagus
Cryospray ablation
ICE
Cryotherapy
Cryo
CryoSpray

Additional relevant MeSH terms:
Barrett Esophagus
Hyperplasia
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on October 29, 2014