Clinical trial · Interventional
Clinical Study to Evaluate CryoBalloon™ Ablation System in Patients Undergoing Esophagectomy
Clinical Study to Evaluate the CryoBalloon™ Full Ablation System for the Ablation of Human Esophageal Epithelium in Patients Undergoing Esophagectomy
NCT02729727CI-TRIAL-00058112completedN/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)
To evaluate the safety and treatment effect of the CryoBalloon™ Full Ablation System for the ablation of human esophageal epithelium in patients scheduled to undergo esophagectomy
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 |
|---|---|---|---|
| CryoBalloon Ablation System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Single Arm
- description
- To evaluate safety and treatment effect of the CryoBalloon Ablation System for the Ablation of human esophageal epithelium in patients scheduled to undergo esophagectomy
- interventionNames
- Device: CryoBalloon Ablation System
Primary outcomes (1)
- measure
- Safety of CryoBalloon Ablation System
- timeFrame
- through study completion, an average of 2 weeks
- description
- Incidence of device related serious adverse events
Secondary outcomes (1)
- measure
- Device Performance
- timeFrame
- through study completion, an average of 2 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Up to two (2) areas of 3 cm each non-ulcerated, columnar lined esophagus or squamous linted tissue suitable for ablation * Older than 18 years of age at the time of consent * Requires a clinically-necessary esophagectomy for esophageal cancer * Patient has provided written informed consent using the Informed Consent Form approved by the Institution's reviewing Medical Ethics Committee (MEC) Exclusion Criteria: * Patient refuses or is unable to provide written informed consent * Patient has esophageal narrowing limiting access to the intended site of ablation
References
Publications (0)
Data not yet available
No reference posted for this study.