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Spray Cryotherapy for Esophageal Cancer (ICE-CANCER)

NCT01868139 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2022-03-07

Study results available
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Summary

The goal of this study is to evaluate the safety and efficacy of endoscopic spray cryotherapy using the CSA Medical, Inc. truFreeze System for patients with previously untreated early-stage cancer (T1a, N0, M0) who are ineligible or refuse conventional therapy including surgery, chemotherapy, radiation therapy, and endoscopic resection.

It is hypothesized that one of the two following outcomes will occur:

1. Complete response to therapy: complete tumor eradication confirmed through histologic examination of biopsy specimens from the targeted esophageal tissue site;
2. Stable disease: tumor remission is not attained, but disease progression is halted.

Conditions

  • Esophageal Cancer

Interventions

DEVICE

Liquid nitrogen spray cryotherapy with the truFreeze device

Low-pressure liquid nitrogen is sprayed through an upper endoscope on the diseased esophageal tissue to freeze and destroy it. The upper endoscope enables direct visualization of mucosal freeze during spray of the liquid nitrogen onto the mucosa and avoids the need for direct contact with the tissues. The target area is frozen and thawed for several consecutive cycles. The treated tissue becomes necrotic and sloughs, with new, healthy tissue regenerating in its place.

Sponsors & Collaborators

  • University of Maryland, Baltimore

    lead OTHER

Principal Investigators

  • Bruce D Greenwald, MD · University of Maryland

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2014-12-31
Completion
2014-12-31

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 NCT01868139 on ClinicalTrials.gov