CryoSpray Ablation (TM) GI Patient Registry

CSA Medical, Inc.199 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

199

Conditions

Barrett's Esophagus Esophageal Cancer

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (6)

The Scripps Research Institute

La Jolla, California, United States

University of Maryland Medical Center

Baltimore, Maryland, United States

Syosset Hospital

Lake Success, New York, United States

University of North Carolina-Chapel Hill

Chapel Hill, North Carolina, United States

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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