CryoSpray Ablation (TM) GI Patient Registry

Completed

• Conditions: Barrett's Esophagus; Esophageal Cancer

• Registration Number: NCT00747448
• Lead Sponsor: CSA Medical, Inc.

Brief Summary

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.

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.

Study Timeline

• Study First Submitted: 2008-09-04
• Study First Submitted QC: 2008-09-04
• Study First Posted: 2008-09-05
• Study Start: 2009-05
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-01
• Last Update Posted: 2016-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 199

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	2 years post treatment

Trial Locations

Locations (6)

University of Maryland Medical Center; 🇺🇸 Baltimore, Maryland, United States

The Scripps Research Institute; 🇺🇸 LaJolla, California, United States

Syosset Hospital; 🇺🇸 Lake Success, New York, United States

University of North Carolina-Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States

Rhode Island Hospital; 🇺🇸 Providence, Rhode Island, United States