Clinical trial · Interventional
Evaluation of Effect of CryoBalloon Focal Ablation System on Human Esophageal Epithelium
NCT02534233CI-TRIAL-00093000ColdPlay2completedN/AResults postedClinicalTrials.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)
Assess Cryoablation (CryoBalloon Ablation cryotherapy) for treatment of Dysplastic Barrett's Esophagus, Esophageal Squamous Dysplasia and early Esophageal Cancer. The cryoablation treatment will be offered as an alternative to standard ablation therapies such as Radiofrequency Ablation, Argon Plasma Coagulation and carbon dioxide Cryotherapy).
Conditions
Conditions (3)
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 |
| Esophageal Squamous Dysplasia | Esophageal Squamous Intraepithelial Neoplasia | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CryoBalloon | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CryoBalloon ablation
- description
- Patients having ablation of dysplastic tissue in esophagus.
- interventionNames
- Device: CryoBalloon
Primary outcomes (3)
- measure
- Number of Participants With Complete Eradication of Esophageal Dysplasia
- timeFrame
- 12 months
- description
- Evaluate histopathology of esophageal tissue for absence of Barrett's esophagus or squamous dysplasia after cryoablation treatments (assess for complete eradication of dysplasia).
- measure
- Treatment-related Adverse Events Assessed by Pain Scale
- timeFrame
- 1 day post treatment (day 2), 1 week post treatment (day 8), and 1 month (day 31)
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients recommended for ablation of either Barrett's esophagus with dysplasia or esophageal squamous dysplasia, scheduled for upper endoscopy. Exclusion Criteria: * Patient unable to undergo endoscopy, * Patients with visible esophageal mass.
References
Publications (2)
- RESULTCanto MI, Shaheen NJ, Almario JA, Voltaggio L, Montgomery E, Lightdale CJ. Multifocal nitrous oxide cryoballoon ablation with or without EMR for treatment of neoplastic Barrett's esophagus (with video). Gastrointest Endosc. 2018 Sep;88(3):438-446.e2. doi: 10.1016/j.gie.2018.03.024. Epub 2018 Apr 5. PMID 29626424
- RESULTCanto MI, Abrams JA, Kunzli HT, Weusten B, Komatsu Y, Jobe BA, Lightdale CJ. Nitrous oxide cryotherapy for treatment of esophageal squamous cell neoplasia: initial multicenter international experience with a novel portable cryoballoon ablation system (with video). Gastrointest Endosc. 2018 Feb;87(2):574-581. doi: 10.1016/j.gie.2017.07.013. Epub 2017 Jul 16. PMID 28720474