trūFreeze® Palliative Esophageal Cancer

• ClinicalTrials.gov Identifier: NCT03243734
• Recruitment Status: Active, not recruiting
• First Posted: August 9, 2017
• Last Update Posted: July 25, 2022
• Sponsor: US Endoscopy Group Inc.
• Information provided by (Responsible Party): US Endoscopy Group Inc.

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Esophageal Cancer	Device: trūFreeze® System spray cryotherapy	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 51 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: A Prospective Single Arm Multicenter Study Evaluating the Effects of Spray Cryotherapy in Patients With Persistent Local Esophageal Cancer
• Actual Study Start Date: November 6, 2017
• Actual Primary Completion Date: July 13, 2022
• Estimated Study Completion Date: May 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Change from baseline EORTC at 14 days post cryotherapy procedure [ Time Frame: 14 days post spray cryotherapy ]
   Validated Cancer Specific Quality of Life Questionnaire
2. Change from baseline dysphagia scale at 14 days post cryotherapy procedure [ Time Frame: 14 days post spray cryotherapy ]
   Dysphagia Severity Scale

Secondary Outcome Measures :

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

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Locations

United States, Arizona

Cancer Treatment Centers of America Western Regional Medical Center

Goodyear, Arizona, United States, 85338

United States, California

University of California at Irvine

Orange, California, United States, 92868

United States, Georgia

Emory University

Atlanta, Georgia, United States, 30322

United States, Indiana

Parkview Comprehensive Cancer Center

Fort Wayne, Indiana, United States, 46845

United States, Michigan

Spectrum Health

Grand Rapids, Michigan, United States, 49546

United States, New Hampshire

Dartmouth-Hotchcock Medical Center

Lebanon, New Hampshire, United States, 03756

United States, New York

North Shore-Long Island Jewish Medical Center

Manhasset, New York, United States, 11030

University of Rochester

Rochester, New York, United States, 14642

United States, North Carolina

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States, 27599

United States, Virginia

Virginia Commonwealth University

Richmond, Virginia, United States, 23298

Sponsors and Collaborators

US Endoscopy Group Inc.

Investigators

• Principal Investigator: Nicholas Shaheen, MD; University of North Carolina, Chapel Hill

More Information

• Responsible Party: US Endoscopy Group Inc.
• ClinicalTrials.gov Identifier: NCT03243734
• Other Study ID Numbers: 017
• First Posted: August 9, 2017
• Last Update Posted: July 25, 2022
• Last Verified: July 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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

Keywords provided by US Endoscopy Group Inc.:

spray cryotherapy; quality of life; symptom reduction; esophageal malignancies; liquid nitrogen; ablation

Additional relevant MeSH terms:

Esophageal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases