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

March 12, 2014 updated by: CSA Medical, Inc.

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

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

78

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
2 years post treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
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
2 years post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CSA Medical, Inc.

Investigators

  • Principal Investigator: Bruce Greenwald, M.D., University of Maryland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

September 1, 2009

Study Registration Dates

First Submitted

September 5, 2007

First Submitted That Met QC Criteria

September 5, 2007

First Posted (Estimate)

September 10, 2007

Study Record Updates

Last Update Posted (Estimate)

March 14, 2014

Last Update Submitted That Met QC Criteria

March 12, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-00016-00

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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