Know Cancer

or
forgot password

CryoSpray Ablation (TM) GI Patient Registry


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

Thank you

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 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