Status:
COMPLETED
trūFreeze® Palliative Esophageal Cancer
Lead Sponsor:
US Endoscopy Group Inc.
Conditions:
Esophageal Cancer
Eligibility:
All Genders
18-89 years
Phase:
NA
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 bee...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 6 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 6 2024
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT03243734
Start Date
November 6 2017
End Date
March 6 2024
Last Update
May 8 2024
Active Locations (10)
Enter a location and click search to find clinical trials sorted by distance.
1
Cancer Treatment Centers of America Western Regional Medical Center
Goodyear, Arizona, United States, 85338
2
University of California at Irvine
Orange, California, United States, 92868
3
Emory University
Atlanta, Georgia, United States, 30322
4
Parkview Comprehensive Cancer Center
Fort Wayne, Indiana, United States, 46845