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trūFreeze® esophageal cancer: A prospective single-arm multicenter study evaluating the effects of spray cryotherapy in patients with persistent local esophageal cancer

Description

The purpose of this trial is to study the effects of the trūFreeze® Spray Cryotherapy System in subjects who have been diagnosed with persistent local esophageal cancer and who are not surgical candidates or have completed or declined systemic therapy.

Status

Accepting new patients

Primary Study Objective(s)

The study's primary objective is to describe the changes in symptoms and quality of life before and after treatment.

Core eligibility

Note: This is only a partial list of eligibility criteria.

Including patients who:

  • Are 18 to 89 years old
  • Can read, understand and sign a written informed consent document to participate in the study
  • Has persistent esophageal cancer with local luminal involvement and who is not a candidate for surgery or who has completed or declined systemic therapy
  • Can tolerate an endoscopic procedure

Excluding patients who:

  • Are pregnant, nursing or plan to get pregnant during the study duration
  • Have an esophageal stent in situ at the time of study enrollment
  • Have been deemed by the treating investigator to have a contraindication for an endoscopy or spray cryotherapy procedure
  • Have received radiation within the past six weeks
  • Have received chemotherapy within the past two weeks
  • Have participated in another clinical trial for systemic therapy within six weeks of baseline
  • Have had previous spray cryotherapy for esophageal cancer