A Prospective Single Arm Multicenter Study Evaluating the Effects of Spray Cryotherapy in Patients With Persistent Local Esophageal Cancer

Status: Active, not recruiting
Location: See all (10) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Prospective, open label, non-controlled single arm, multi-center study The primary objective is to study the effects of the trūFreeze® Spray Cryotherapy System in a population of subjects who have been diagnosed with persistent local esophageal cancer and who are not surgical candidates or have completed or declined systemic therapy.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 89
Healthy Volunteers: No
View:

• Males and females of 18 to 89 years of age.

• Subject is able to read, understand, and sign a written Informed Consent to participate in the study.

• Subject has persistent esophageal cancer with local luminal involvement and who is not a surgical candidate or has completed or declined systemic therapy.

• Subject is able to tolerate endoscopy

Locations
United States
Arizona
Cancer Treatment Centers of America Western Regional Medical Center
Goodyear
California
University of California at Irvine
Orange
Georgia
Emory University
Atlanta
Indiana
Parkview Comprehensive Cancer Center
Fort Wayne
Michigan
Spectrum Health
Grand Rapids
North Carolina
University of North Carolina at Chapel Hill
Chapel Hill
New Hampshire
Dartmouth-Hotchcock Medical Center
Lebanon
New York
North Shore-Long Island Jewish Medical Center
Manhasset
University of Rochester
Rochester
Virginia
Virginia Commonwealth University
Richmond
Time Frame
Start Date: November 6, 2017
Estimated Completion Date: May 2023
Participants
Target number of participants: 51
Treatments
Experimental: trūFreeze® System spray cryotherapy
trūFreeze® System spray cryotherapy as clinically indicated for symptom relief
Related Therapeutic Areas
Sponsors
Leads: US Endoscopy Group Inc.

This content was sourced from clinicaltrials.gov

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