We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

trūFreeze® Palliative Esophageal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03243734
Recruitment Status : Recruiting
First Posted : August 9, 2017
Last Update Posted : December 12, 2017
Information provided by (Responsible Party):
CSA Medical, Inc.

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 Phase 4

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 dysphasia 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 and enrollment is anticipated to take 12 months.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
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
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2021

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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 participated in another clinical study for systemic therapy within 6 weeks of baseline.
  • Subject has had previous Spray Cryotherapy for esophageal cancer.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03243734

Contact: Jane Solomon, RN 781-538-4794 jsolomon@csamedical.com
Contact: Ann Murphy-Legg, BS 781-538-4732 alegg@csamedical.com

United States, California
University of California at Irvine Not yet recruiting
Orange, California, United States, 92868
Contact: Douglas O'Connell    714-456-7033    douglaeo@uci.edu   
United States, Indiana
Parkview Comprehensive Cancer Center Recruiting
Fort Wayne, Indiana, United States, 46845
Contact: Christina Zelt, MSN    260-266-4153    christina.zelt@parkview.com   
United States, New York
University of Rochester Recruiting
Rochester, New York, United States, 14642
Contact: Krystle Bittner, MPH    585-275-4711    krystle_bittner@URMC.Rochester.edu   
Contact: Gianni Harris, BS       gianni_harris@urmc.rochester.edu   
Principal Investigator: Vivek Kaul, MD         
Sub-Investigator: Shivangi T Kothari, MD         
United States, North Carolina
University of North Carolina at Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Jacquelyn Covington    919-966-0139    jacquelyn_covington@med.unc.edu   
Contact: Susan Moist, MPH    919-966-7555    susan_moist@med.unc.edu   
Principal Investigator: Nicholas J Shaheen, MD, MBA         
Sponsors and Collaborators
CSA Medical, Inc.
Principal Investigator: Nicholas Shaheen, MD University of North Carolina, Chapel Hill

Responsible Party: CSA Medical, Inc.
ClinicalTrials.gov Identifier: NCT03243734     History of Changes
Other Study ID Numbers: 017
First Posted: August 9, 2017    Key Record Dates
Last Update Posted: December 12, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by CSA Medical, Inc.:
spray cryotherapy
quality of life
symptom reduction
esophageal malignancies
liquid nitrogen

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases