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Study of CryoSpray Ablation(TM)to Determine Treatment Effect, Depth of Injury, and Side Effects in the Esophagus.

NCT00754468 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2015-11-04

Study results available
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Summary

The purpose of this study is to evaluate the treatment effect, depth of injury, and side effects using technology involving the spray of liquid nitrogen through a catheter (CryoSpray AblationTM, "CSA" or "cryospray therapy") onto healthy tissue via esophagogastroduodenoscopy (EGD) using surgical resection specimens from subjects undergoing esophagectomy.

Conditions

  • Barrett's Esophagus
  • Esophageal Cancer

Interventions

DEVICE

Cryo Spray Ablation

Cryo Spray Ablation 4 cycles x 10 seconds treatment

DEVICE

Cryo Spray Ablation

Cryo Spray Ablation 2 cycles x 20 seconds

Sponsors & Collaborators

  • University of Miami

    collaborator OTHER

  • CSA Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Afonso Ribeiro, M.D. · University of Miami Sylvester Comprehensive Cancer Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2012-03-31
Completion
2012-03-31

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 NCT00754468 on ClinicalTrials.gov