CryoSpray Ablation (TM) GI Patient Registry
18 Years
N/A
Both
Barrett's Esophagus With or Without Dysplasia, Squamous Dysplasia of the Esophagus, Esophageal Cancer (Any Stage)
Trial Information
CryoSpray Ablation (TM) GI Patient Registry
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.
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.
Type of Study:
Observational
Study Design:
Observational Model: Case-Only
Outcome Measure:
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.
Outcome Time Frame:
2 years post treatment
Safety Issue:
No
Principal Investigator
Paul Manburg, PhD
Investigator Role:
Study Director
Investigator Affiliation:
CSA Medical, Inc.
Authority:
United States: Institutional Review Board
Study ID:
17-00030
NCT ID:
NCT00747448
Start Date:
May 2009
Completion Date:
December 2014
Related Keywords:
- Barrett's Esophagus With or Without Dysplasia
- Squamous Dysplasia of the Esophagus
- Esophageal Cancer (Any Stage)
- Barrett's Esophagus
- High Grade Dysplasia
- Low Grade Dysplasia
- Squamous Dysplasia
- Esophageal Cancer
- CryoSpray Ablation
- Cryotherapy
- Cryospray
- Barrett Esophagus
- Esophageal Diseases
- Esophageal Neoplasms
- Hyperplasia
Name | Location |
|---|---|
| Cleveland Clinic Foundation | Cleveland, Ohio 44195 |
| Rhode Island Hospital | Providence, Rhode Island 02903 |
| University of Maryland Medical Center | Baltimore, Maryland 21201-1595 |
| The Scripps Research Institute | LaJolla, California 92037 |
| Syosset Hospital | Lake Success, New York 10042 |
| University of North Carolina-Chapel Hill | Chapel Hill, North Carolina 27599 |
