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Cryotherapy for Barrett's Esophagus and Early Esophageal Cancers

NCT00650988 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2012-12-24

No results posted yet for this study

Summary

This is a single center study to evaluate the efficacy and safety of a new ablation technique involving the spray of liquid nitrogen through a catheter (cryotherapy) via an upper endoscopy (EGD) to ablate Barrett's esophagus with changes of high-grade dysplasia (HGD) or intramucosal cancer (IMCA) and patients with esophageal cancer limited to the esophageal wall, in whom there are no standard treatment options available.

Conditions

  • Barretts Esophagus
  • Esophageal Cancer

Interventions

PROCEDURE

Cryospray Ablation

Liquid nitrogen spray with a cryospray catheter through an upper endoscope that enables the direct visualization of mucosal freeze (cryoburn) of the mucosa treated which avoids the need for direct tissue contact. Frozen state is defined as mucosa appearing white. Cryofreeze is preformed in cycles of 10 second sprays with a minimal thaw of 60 seconds each spray. This cycle is repeated 4 times in each area of treatment.

Sponsors & Collaborators

  • Case Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • John A. Dumot, D.O. · The Cleveland Clinic

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-09-30
Primary Completion
2008-05-31
Completion
2008-12-31

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 NCT00650988 on ClinicalTrials.gov