trūFreeze® Palliative Esophageal Cancer
Completed · Not applicable
Conditions studied: Esophageal Cancer
In brief
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.
Key facts
- Study ID
- NCT03243734
- Run by
- US Endoscopy Group Inc.
- People needed
- 49
- Starts
- 2017-11-06
- Expected to finish
- 2024-03-06
- Last updated by the study team
- 2024-05-08
Who can join
Age: 18 and older, up to 89. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Cancer Treatment Centers of America Western Regional Medical Center — Goodyear, Arizona, United States
- University of California at Irvine — Orange, California, United States
- Emory University — Atlanta, Georgia, United States
- Parkview Comprehensive Cancer Center — Fort Wayne, Indiana, 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 Rochester — Rochester, New York, United States
- University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
- Virginia Commonwealth University — Richmond, Virginia, United States
Full record on ClinicalTrials.gov
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