trūFreeze® Palliative Esophageal Cancer

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Esophageal Cancer
• Intervention / Treatment: Device: trūFreeze® System spray cryotherapy

Detailed Description

The use of cryotherapy delivered with the trūFreeze® System via noncontact spray ablates the cancer cells while allowing adjacent normal tissue to regenerate. When the liquid nitrogen is delivered to the malignant lesion the cancer cells undergo ablation induced by intracellular water being frozen in place such that ice crystals are formed. These ice crystals aggregate quickly causing immediate intracellular energy producing organelles to be destroyed leading to a non-viable cell. Subsequent tumor sloughing and absorption of apoptotic cells occurs with a subsequent debulking of the tumor mass. Normal tissue will regenerate as re-epithelialization occurs. The extreme cold of -196 degrees Celsius or a "hard freeze" leads to more extensive primary cell death over a shorter freeze time as compared to cryoprobes. A reduction of overall tumor obstruction in the esophageal lumen can reduce symptoms of dysphagia, delay the time until stent is needed, provide palliative care for patients for whom additional tri-modal therapies are not an option, and may increase quality of life in esophageal cancer patients. The studies conducted to date have provided documentation of the safety and effectiveness of spray cryotherapy (SCT) when used for malignancies in the esophagus. Measures of dysphagia relief have been described in peer reviewed literature. This study aims to provide much needed HRQOL information as well as additional tumor characteristics before and after SCT. A cohort of patients with locally persistent esophageal cancer will be studied in up to twelve (12) centers in the United States to provide important HRQOL data and more a comprehensive understanding of clinical tumor response post SCT. In the proposed study, the trūFreeze® System spray cryotherapy procedure will be performed during endoscopy. Each SCT procedure will be performed endoscopically at clinically indicated intervals of 6 weeks +/- 3 weeks. Total procedure dosimetry will be delivered at the discretion of the Investigator based on tumor location and patient tolerability. After each procedure at defined intervals, patients will be contacted and QOL symptom related information will be collected. If at any point an Investigator determines that a subject is not a candidate for further spray cryotherapy or is unable to tolerate additional procedures, they will be contacted via telephone to ascertain HRQOL information. Subject participation will last up to two years or until death

• Study Type: Interventional
• Enrollment (Estimated): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Goodyear, Arizona, United States, 85338
      • Cancer Treatment Centers of America Western Regional Medical Center
  • California
    • Orange, California, United States, 92868
      • University of California at Irvine
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University
  • Indiana
    • Fort Wayne, Indiana, United States, 46845
      • Parkview Comprehensive Cancer Center
  • Michigan
    • Grand Rapids, Michigan, United States, 49546
      • Spectrum Health
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth-Hotchcock Medical Center
  • New York
    • Manhasset, New York, United States, 11030
      • North Shore-Long Island Jewish Medical Center
    • Rochester, New York, United States, 14642
      • University of Rochester
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina At Chapel Hill
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Subject is pregnant, nursing, or planning to get pregnant during study duration.
• Subjects with an esophageal stent in situ at the time of study enrollment
• Subject, as deemed by treating investigator has contraindication to endoscopy or Spray Cryotherapy Procedure.
• Subject has received radiation within the past 6 weeks
• Subject has received chemotherapy within the past 2 weeks Subject has received immunotherapy within 30 days
• Subject has participated in another clinical study for systemic therapy within 6 weeks of baseline.
• Subject has had previous Spray Cryotherapy for esophageal cancer.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: trūFreeze® System spray cryotherapy; trūFreeze® System spray cryotherapy as clinically indicated for symptom relief	Device: trūFreeze® System spray cryotherapy; Subjects where trūFreeze® System spray cryotherapy is performed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline EORTC at 14 days post cryotherapy procedure	Validated Cancer Specific Quality of Life Questionnaire	14 days post spray cryotherapy
Change from baseline dysphagia scale at 14 days post cryotherapy procedure	Dysphagia Severity Scale	14 days post spray cryotherapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to additional interventional procedure(s) other than spray cryotherapy (e.g. stent placement)	baseline to procedure other than spray cryotherapy	up to 2 years post SCT procedure
Overall Survival	SCT to death	up to 2 years post SCT procedure
Mean change in the amount of residual tumor from baseline to follow-up cryospray delivery session	Describe changes in tumor	up to 2 years post SCT procedure

Collaborators and Investigators

• Sponsor: US Endoscopy Group Inc.
• Investigators: Principal Investigator: Nicholas Shaheen, MD, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2017
• Primary Completion (Actual): July 13, 2022
• Study Completion (Estimated): March 6, 2024

Study Registration Dates

• First Submitted: August 3, 2017
• First Submitted That Met QC Criteria: August 4, 2017
• First Posted (Actual): August 9, 2017

Study Record Updates

• Last Update Posted (Actual): September 18, 2023
• Last Update Submitted That Met QC Criteria: September 15, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: quality of life; ablation; spray cryotherapy; symptom reduction; esophageal malignancies; liquid nitrogen
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Head and Neck Neoplasms; Esophageal Diseases; Esophageal Neoplasms
• Other Study ID Numbers: 017

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No