trūFreeze® Palliative Esophageal Cancer

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