Clinical trial · Interventional
trūFreeze® Palliative Esophageal Cancer
A Prospective Single Arm Multicenter Study Evaluating the Effects of Spray Cryotherapy in Patients With Persistent Local Esophageal Cancer
NCT03243734CI-TRIAL-00076914completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| trūFreeze® System spray cryotherapy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- trūFreeze® System spray cryotherapy
- description
- trūFreeze® System spray cryotherapy as clinically indicated for symptom relief
- interventionNames
- Device: trūFreeze® System spray cryotherapy
Primary outcomes (2)
- measure
- Change from baseline EORTC at 14 days post cryotherapy procedure
- timeFrame
- 14 days post spray cryotherapy
- description
- Validated Cancer Specific Quality of Life Questionnaire
- measure
- Change from baseline dysphagia scale at 14 days post cryotherapy procedure
- timeFrame
- 14 days post spray cryotherapy
- description
- Dysphagia Severity Scale
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 89 Years
Show eligibility criteria text
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 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.
References
Publications (0)
Data not yet available
No reference posted for this study.