Clinical trial · Interventional
Evaluation of Balloon-based Cryoablation of Human Esophageal Epithelium
NCT01293448CI-TRIAL-00058104completedN/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)
The purpose of this study is to evaluate a cryoablation technique used to ablate human esophageal mucosa.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Barrett's Esophagus | — | UNRESOLVED | — |
| Esophageal Cancer | Malignant Esophageal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cryoballoon Ablation | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intervention
- description
- CryoBalloon ablation of esophageal tissue in patients scheduled for esophagectomy for reasons unrelated to the objective of the study.
- interventionNames
- Device: Cryoballoon Ablation
Primary outcomes (1)
- measure
- Treatment effect
- timeFrame
- Within 30 days of ablation procedure
- description
- The primary outcome measure is to evaluate the histological results (depth of injury) of a cryoballoon ablation system.
Secondary outcomes (2)
- measure
- Post-ablation symptoms
- timeFrame
- Within 7 days of ablation procedure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Patient must have a minimum of 2.0 cm of non-ulcerated, non-inflammatory columnar-lined esophagus or squamous esophageal lined tissue suitable for ablation. A patient may be treated with up to 2 zones of ablation. * Patient is 18 to 80 years of age at the time of consent (inclusive). * Patient has provided written Informed Consent Form (IFC) using a form that has been approved by the Institution's reviewing IRB/EC. * Patient is willing and able to comply with all Clinical Investigation Plan (CIP) requirements. * Patient's esophagectomy is clinically necessary due to reasons unrelated to this study. * Patient is deemed operable per standard institutional criteria. Exclusion Criteria: * Patient has a known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to IFC, post treatment instructions or follow-up guidelines. * Patient refuses or is unable to provide written informed consent. - - * Patient has or is currently undergoing endoscopic ablation therapy within 4 cm from the proposed treatment area including, but not limited to cryospray therapy, laser treatment, photodynamic therapy, multi-polar electro coagulation, endoscopic mucosal resection, radiofrequency ablation or argon plasma coagulation. * Patient has esophageal narrowing limiting access to the intended site of ablation. * Patient is undergoing or has recently undergone chemotherapy (within 15 days or WBC below normal by institutional criteria or standards). * Patient is undergoing or has recently undergone radiation therapy which involved the esophagus (within 15 days or WBC below normal by institutional criteria or standards).
References
Publications (0)
Data not yet available
No reference posted for this study.