trūFreeze® Palliative Esophageal Cancer

Esophageal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03243734
• Other study ID #: 017
• Status: Completed
• Phase: N/A
• Start date: November 6, 2017
• Est. completion date: March 6, 2024

Study information

• Verified date: September 2023
• Source: US Endoscopy Group Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: March 6, 2024
• Est. primary completion date: July 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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.

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms

Intervention

Device:
• truFreeze® System spray cryotherapy
Subjects where truFreeze® System spray cryotherapy is performed

Locations

Country	Name	City	State
United States	Emory University	Atlanta	Georgia
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Parkview Comprehensive Cancer Center	Fort Wayne	Indiana
United States	Cancer Treatment Centers of America Western Regional Medical Center	Goodyear	Arizona
United States	Spectrum Health	Grand Rapids	Michigan
United States	Dartmouth-Hotchcock Medical Center	Lebanon	New Hampshire
United States	North Shore-Long Island Jewish Medical Center	Manhasset	New York
United States	University of California at Irvine	Orange	California
United States	Virginia Commonwealth University	Richmond	Virginia
United States	University of Rochester	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
US Endoscopy Group Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline EORTC at 14 days post cryotherapy procedure	Validated Cancer Specific Quality of Life Questionnaire	14 days post spray cryotherapy
Primary	Change from baseline dysphagia scale at 14 days post cryotherapy procedure	Dysphagia Severity Scale	14 days post spray cryotherapy
Secondary	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
Secondary	Overall Survival	SCT to death	up to 2 years post SCT procedure
Secondary	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