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CryoSpray Ablation (TM) GI Patient Registry

18 Years
Open (Enrolling)
Barrett's Esophagus With or Without Dysplasia, Squamous Dysplasia of the Esophagus, Esophageal Cancer (Any Stage)

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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:


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:


Principal Investigator

Paul Manburg, PhD

Investigator Role:

Study Director

Investigator Affiliation:

CSA Medical, Inc.


United States: Institutional Review Board

Study ID:




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



Cleveland Clinic FoundationCleveland, Ohio  44195
Rhode Island HospitalProvidence, Rhode Island  02903
University of Maryland Medical CenterBaltimore, Maryland  21201-1595
The Scripps Research InstituteLaJolla, California  92037
Syosset HospitalLake Success, New York  10042
University of North Carolina-Chapel HillChapel Hill, North Carolina  27599