Clinical trial · Interventional
Cryo Balloon for Residual Barrett's Esophagus
CryoBalloon Focal Ablation System for Residual Barretts Esophagus Post Ablation; a Pilot Study.
NCT02230410CI-TRIAL-00056472CryoballooncompletedN/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)
This study is being done to see if treating residual Barrett's Esophagus after previously having undergone Radiofrequency ablation or Endoscopic Mucosal resection can be eliminated with focal cryotherapy.
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 |
|---|---|---|---|
| Barrett's Esophagus | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CryoBalloon Focal Ablation | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- focal cryo ablation
- description
- Subjects with residual barrett's esophagus (less than 3 cm) post ablation will under go one CryoBalloon Focal Ablation treatment
- interventionNames
- Device: CryoBalloon Focal Ablation
Primary outcomes (1)
- measure
- Eradication of Barrett's Esophagus
- timeFrame
- 3 months post Cryoballon Focal Ablation
- description
- Number of subjects to have eradication of barrett's esophagus after Cryoballoon Focal Ablation
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: * Age \> 18 years old * Able to provide informed consent * Patients with unifocal or multifocal BE with 2 cm who have failed at least 2 serial RFA or other endoscopic therapy such as Endoscopic Mucosal resection, Exclusion criteria: * Age younger than 18 years old * Presence of esophageal varices * Esophageal stricture precluding passage of an endoscope * Inability to provide informed consent * Esophageal cancer (T2 and above) * Coagulopathy with INR \> 2.0, thrombocytopenia with platelet counts \< 50,000 * Pregnancy (if required a pregnancy test would be performed as part of routine clinical care)
References
Publications (0)
Data not yet available
No reference posted for this study.