Clinical trial · Interventional
Multi-center Clinical Study to Evaluate the C2 CryoBalloon Focal Ablation System
Multi-center Clinical Study to Evaluate the C2 CryoBalloon Focal Ablation System for the Treatment of Patients With Previously Untreated Dysplastic Barrett's Epithelium
NCT02514525CI-TRIAL-00084590ColdPlayIIIactive not recruitingN/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 efficacy and safety of the CryoBalloon Focal Ablation System for the treatment of previously-untreated ("treatment naïve") Barrett's Esophagus (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 Esophagus | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CryoBalloon Ablation System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- CryoBalloon Ablation System
- description
- Cryoablation treatment of patients with previously untreated (treatment naïve) Barrett's epithelium.
- interventionNames
- Device: CryoBalloon Ablation System
Primary outcomes (4)
- measure
- Incidence of serious, CryoBalloon Ablation System-related adverse events
- timeFrame
- 12 months
- measure
- Percentage of patients with baseline LGD who have complete eradication of all dysplasia
- timeFrame
- 12 months
- measure
- percentage of patients with baseline HGD who have complete eradication of all dysplasia
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria:
* Low- or high-grade non-nodular, previously untreated ("treatment naïve") dysplastic BE, confirmed by histopathological analysis. If nodular BE or Intramuscosal Cancer (ImCA) is identified during patient screening, this may be treated with Endoscopic Mucosal Resection (EMR) ≥6 weeks prior to treatment under this protocol. If previous EMR was performed, follow-up endoscopy must be negative for nodular BE. Patients with ImCA must be at low risk for recurrence, confirmed by EMR pathology results negative for positive margin, poorly differentiated carcinoma, and lymphovascular invasion.
* BE length ≤6cm excluding visible BE islands, and Prague Classification C ≥0 / M ≥1
* Older than 18 years of age at time of consent
* Operable per institution's standards
* Provides written informed consent on the approved informed consent form
* Willing and able to comply with study requirements for follow-up
Exclusion Criteria:
* Non-dysplastic or indefinite for dysplasia BE, confirmed by histopathological analysis
* Esophageal stenosis/stricture preventing advancement of a therapeutic endoscope (patients may have the stenosis/stricture dilated and then be treated with CryoBalloon ablation under this protocol at a subsequent procedure ≥2 weeks later)
* Symptomatic untreated strictures
* Any endoscopically-visualized abnormalities such as ulcers, masses or nodules. Neoplastic nodules must first be treated with EMR ≥6 weeks prior to planned treatment under this protocol.
* History of esophageal cancer more extensive than T1a or not meeting criteria for low risk of recurrence (confirmed by EMR pathology results negative for positive margin, poorly differentiated carcinoma, and lymphovascular invasion)
* History of esophageal varices
* Large (\>4cm) hiatal hernia
* Prior distal esophagectomy
* Any clinical or histological suspicion of esophageal adenocarcinoma invading into the submucosa by endoscopic mucosal resection (EMR), or confirmed T1a cancer with positive deep margin by EMR
* Active esophagitis grade B or higher
* Severe medical comorbidities precluding endoscopy
* Uncontrolled coagulopathy
* Pregnant or planning to become pregnant during period of study participation
* Patient refuses or is unable to provide written informed consent
* Life expectancy ≤3 years, as judged by the site investigator
* General poor health, multiple co-morbidities placing the patient at risk or otherwise unsuitable for trial participationReferences
Publications (2)
- DERIVEDCanto MI, Trindade AJ, Chak A, Dumot JA, Iyer PG, Khara HS, Diehl DL, Corbett FS, Shin EJ, McKinley M, Waxman I, Infantolino A, Tofani CJ, Chang KJ, Lightdale CJ, Goldblum JR, Voltaggio L, Montgomery EA, Abrams JA, Shaheen NJ. Durability of cryoballoon ablation for eradication of neoplastic Barrett's esophagus: a multicenter prospective cohort study (with video). Gastrointest Endosc. 2026 Jun;103(6):1153-1162.e1. doi: 10.1016/j.gie.2025.11.030. Epub 2025 Nov 21. PMID 41275893
- DERIVEDCanto MI, Trindade AJ, Abrams J, Rosenblum M, Dumot J, Chak A, Iyer P, Diehl D, Khara HS, Corbett FS, McKinley M, Shin EJ, Waxman I, Infantolino A, Tofani C, Samarasena J, Chang K, Wang B, Goldblum J, Voltaggio L, Montgomery E, Lightdale CJ, Shaheen NJ. Multifocal Cryoballoon Ablation for Eradication of Barrett's Esophagus-Related Neoplasia: A Prospective Multicenter Clinical Trial. Am J Gastroenterol. 2020 Nov;115(11):1879-1890. doi: 10.14309/ajg.0000000000000822. PMID 33156107