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Study of CryoSpray Ablation of Low Grade or High Grade Dysplasia Within Barrett's Esophagus

NCT00526786 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2014-03-14

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and effectiveness of the CryoSpray Ablation System to treat esophageal low grade dysplasia (LGD) or high grade dysplasia (HGD) within Barrett's Esophagus (BE).

Conditions

  • Barrett's Esophagus
  • High Grade Dysplasia
  • Low Grade Dysplasia

Interventions

DEVICE

CryoSpray Ablation System (510(k) NO: K070893)

no drug interventions specified

Sponsors & Collaborators

  • CSA Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Bruce Greenwald, M.D. · University of Maryland

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2009-09-30
Completion
2009-09-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00526786 on ClinicalTrials.gov