Clinical trial · Interventional
Efficacy of CryoBalloon Focal Ablation System on Human Esophageal Barrett's Epithelium
NCT02249975CI-TRIAL-00058118completedN/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 assess the efficacy and performance of the C2 Focal Cryoablation System in patients with BE.
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 |
|---|---|---|---|
| C2 CryoBalloon Focal Ablation System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- C2 CryoBalloon Focal Ablation System
- description
- Cryoballoon ablation will be performed on patients with Barrett's Esophagus.
- interventionNames
- Device: C2 CryoBalloon Focal Ablation System
Primary outcomes (1)
- measure
- Presence of residual Barrett's Esophagus
- timeFrame
- 12 weeks
- description
- Efficacy (% of) Barrett's epithelium fully converted to squamous epithelium upon cryoablation
Secondary outcomes (3)
- measure
- Incidence of adverse events
- timeFrame
- 12 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Criteria Inclusion Criteria * Patients with known Barrett's esophagus, with an indication for ablation therapy during which the cryoablation may be performed. * Patient is 18 to 80 years of age at the time of consent (inclusive). * Patient has provided written Informed Consent (IC) using an Informed Consent Form (ICF) 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 is deemed operable per standard institutional criteria. * BE lesion length \<6cm excluding visible BE islands, and Prague Classification C ≥ 0 / M ≥ 0. * One of the following: Flat LGD, Flat HGD, Residual BE after EMR for visible lesions (containing any degree of dysplasia or low-risk early adenocarcinoma (i.e.: not poorly differentiated, negative vertical (deep) resection margins, absence of (lympho)vascular invasion), Residual BE after a single circumferential RFA (performed for indications listed above: i-iii) * BE lesion within the treatment zone should be flat Exclusion Criteria * Esophageal stenosis preventing advancement of a therapeutic endoscope within 4 cm of treatment zone. * 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. * Patient refuses or is unable to provide written informed consent. * Patients that are pregnant. * Patient with endoscopically active inflammation in the treatment zone. * Endoscopically visible abnormalities such as masses or nodules requiring endoscopic resection.
References
Publications (2)
- RESULTFriedland 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
- DERIVEDvan Munster SN, Overwater A, Haidry R, Bisschops R, Bergman JJGHM, Weusten BLAM. Focal cryoballoon versus radiofrequency ablation of dysplastic Barrett's esophagus: impact on treatment response and postprocedural pain. Gastrointest Endosc. 2018 Nov;88(5):795-803.e2. doi: 10.1016/j.gie.2018.06.015. Epub 2018 Jun 19. PMID 29928869