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A Dose-Optimization Study for the Initial Treatment of Dysplastic Barrett's Esophagus With trūFreeze™ Spray Cryotherapy

NCT01845454 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2016-04-29

No results posted yet for this study

Summary

The primary objective of this study is to determine the percentage segment regression after spray cryotherapy in a dose-escalation study performed in patients with dysplastic Barrett's Esophagus (BE) using trūFreeze™ spray cryotherapy within the currently recommended therapeutic range.

Secondary objectives are the determination of safety related outcomes such as esophageal stricture.

Conditions

  • Barrett's Esophagus

Interventions

DEVICE

trūFreeze™ Spray Cryotherapy

The trūFreeze™ System consists of a console containing a holding tank for medical grade liquid nitrogen and a spray tip CSATM Catheter. The physician uses the console to initiate and control the flow and duration of the cryogen spray. The liquid nitrogen is propelled through a spray CSATM Catheter to the selected site by pressure in the holding tank and freezing techniques are monitored by direct visualization with an endoscope. Once the freezing is completed, the cryogen flow is terminated and the thawing system may be engaged to allow accessory removal. If multiple cycles are used, thawing is initiated at the end of the procedure.

Sponsors & Collaborators

  • CSA Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Nicholas Shaheen, MD, MPH · UNC Chapel Hill

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2014-11-30
Completion
2015-01-31

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 NCT01845454 on ClinicalTrials.gov