Barrett's Esophagus, Esophageal Cancer
Conditions
Keywords
Barrett's Esophagus, High Grade Dysplasia, Low Grade Dysplasia, Squamous Dysplasia, Esophageal Cancer, CryoSpray Ablation, Cryotherapy, Cryospray
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.
Interventions
None listed
Sponsors
CSA Medical, Inc.
Study design
Observational model
CASE_ONLY
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed