Clinical trial · Observational
Evaluation of Effect of CryoBalloon Focal Ablation System on Human Esophageal Barrett's Epithelium
NCT01633411CI-TRIAL-00058138completedClinicalTrials.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 is a feasibility study without a primary study hypothesis or statistical comparison.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CryoBalloon Focal Ablation System - 10 seconds | Device | — | UNRESOLVED |
| Focal Cryoballoon Ablation System - 6 seconds | Device | — | UNRESOLVED |
| Focal Cryoballoon Ablation System - 8 seconds | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Cohort A
- description
- Subjects in Cohort A will receive 6 seconds of treatment to dysplastic esophageal tissue using the Focal CryoBalloon Ablation System.
- interventionNames
- Device: Focal Cryoballoon Ablation System - 6 seconds
- label
- Cohort B
- description
- Subjects in Cohort B will receive 8 seconds of treatment to dysplastic esophageal tissue using the Focal CryoBalloon Ablation System.
- interventionNames
- Device: Focal Cryoballoon Ablation System - 8 seconds
- label
- Cohort C
- description
- Subjects in Cohort C will receive 10 seconds of treatment to dysplastic esophageal tissue using the Focal CryoBalloon Ablation System.
- interventionNames
- Device: CryoBalloon Focal Ablation System - 10 seconds
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients scheduled for ablation, EMR, and/or surveillance for BE (with or without dysplasia). Patient is 18 to 80 years of age at the time of consent (inclusive). 2. Patient has provided written Informed Consent (IC) using an Informed Consent Form (ICF) that has been approved by the Institution's reviewing IRB/EC. 3. Patient is willing and able to comply with all Clinical Investigation Plan (CIP) requirements. 4. Patient is deemed operable per standard institutional criteria. Exclusion Criteria: 1. Patient with endoscopically active inflammation in the treatment zone 2. Esophageal stenosis preventing advancement of a therapeutic endoscope and/or within 4 cm of treatment zone. 3. Patient has a known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to informed consent, post treatment instructions or follow-up guidelines. 4. Patient refuses or is unable to provide written informed consent. 5. Patients that are pregnant.
References
Publications (1)
- BACKGROUNDFriedland S, Triadafilopoulos G. A novel device for ablation of abnormal esophageal mucosa (with video). Gastrointest Endosc. 2011 Jul;74(1):182-8. doi: 10.1016/j.gie.2011.03.1119. Epub 2011 Apr 30. PMID 21531411