CryoSpray Ablation (TM) GI Patient Registry

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CSA Medical, Inc.
ClinicalTrials.gov Identifier:
NCT00747448
First received: September 4, 2008
Last updated: January 8, 2014
Last verified: January 2014
  Purpose

The purpose of this study is to create a patient registry to collect and analyze post-510K approval information on subjects treated endoscopically with the CryoSpray Ablation™ System.


Condition
Barrett's Esophagus With or Without Dysplasia
Squamous Dysplasia of the Esophagus
Esophageal Cancer (Any Stage)

Study Type: Observational
Study Design: Observational Model: Case-Only
Official Title: CryoSpray Ablation (TM) GI Patient Registry

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Primary objectives of the study are to enable analysis of patient outcomes 2 years after final treatment and report on the effectiveness of the device in eradicating, decreasing or downgrading of the lesions. [ Time Frame: 2 years post treatment ] [ Designated as safety issue: No ]

Enrollment: 199
Study Start Date: May 2009
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Detailed Description:

The proposed registry is a prospective, multi-center study of patients that are being currently undergoing CryoSpray Ablation™. It will also be used to catalogue retrospective data from records of patients already treated with the device. A maximum of 40 investigational sites will participate in this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The study population consists of patients who are being treated, or were treated, with the CryoSpray Ablation™ System for malignant or pre-malignant conditions of the esophagus, including:

  1. Barrett's esophagus with or without dysplasia
  2. Squamous dysplasia of the esophagus
  3. Esophageal cancer, any stage, as evidenced by histology.
Criteria

Inclusion Criteria:

  • The study population consists of patients who are being treated, or were treated, with the CryoSpray Ablation™ System for malignant or pre-malignant conditions of the esophagus, including:

    • Barrett's esophagus with or without dysplasia
    • Squamous dysplasia of the esophagus
    • Esophageal cancer, any stage

Exclusion Criteria:

  • Subjects with esophageal lesions whose pathology was not one of the above.
  • Subjects with one of the above conditions who were not treated with the CryoSpray Ablation™ System.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00747448

Locations
United States, California
The Scripps Research Institute
LaJolla, California, United States, 92037
United States, Maryland
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201
United States, New York
Syosset Hospital
Lake Success, New York, United States, 10042
United States, North Carolina
University of North Carolina-Chapel Hill
Chapel Hill, North Carolina, United States, 27599
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Sponsors and Collaborators
CSA Medical, Inc.
Investigators
Study Director: Ann Murphy Legg, RN CSA Medical, Inc.
  More Information

Additional Information:
Publications:
Responsible Party: CSA Medical, Inc.
ClinicalTrials.gov Identifier: NCT00747448     History of Changes
Other Study ID Numbers: 17-00030
Study First Received: September 4, 2008
Last Updated: January 8, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by CSA Medical, Inc.:
Barrett's Esophagus
High Grade Dysplasia
Low Grade Dysplasia
Squamous Dysplasia
Esophageal Cancer
CryoSpray Ablation
Cryotherapy
Cryospray

Additional relevant MeSH terms:
Barrett Esophagus
Esophageal Neoplasms
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms

ClinicalTrials.gov processed this record on April 16, 2014