Clinical trial · Interventional
C2 CryoBalloon™ 180 Ablation System Dose De-escalation Study.
Clinical Trial To Evaluate Safety and Efficacy of the C2 CyroBalloon™ 180 Ablation System for the Treatment of Dysplastic Barrett's Esophagus: CBAS180 De-escalation Study
NCT03311451CI-TRIAL-00112445active 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)
The primary objective is to determine the safety and efficacy of the C2 CryoBalloon 180 Ablation System ("CryoBalloon 180") used at decreasing doses in ablation naïve patients with low- or high-grade dysplastic Barrett's Esophagus (BE) or with residual BE after resection of dysplasia or early adenocarcinoma.
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 |
|---|---|---|---|
| C2 CryoBalloon 180° Ablation System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- C2 CryoBalloon 180 Ablation System
- description
- C2 CryoBalloon 180 Ablation System will be used to ablate visible Barrett's esophagus
- interventionNames
- Device: C2 CryoBalloon 180° Ablation System
Primary outcomes (2)
- measure
- Efficacy: Dose response
- timeFrame
- 10 weeks
- description
- Dose response (efficacy) is defined as eradication percentage of BE confirmed by histological evidence of eradication of BE, after treatment with the therapeutic dose.
- measure
- Safety: Incidence of Dose-related SAEs
- timeFrame
- 30 days
- description
- Safety will be evaluated by the incidence of Dose-related SAEs. Dose-related SAEs include pain in the treatment area, or any stricture (symptomatic or asymptomatic) preventing passage of the diagnostic endoscope at follow-up EGD.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with flat- type BE esophagus, with an indication for ablation therapy, defined as: * Diagnosis of LGD or HGD in BE (confirmed by central pathology review), OR * Residual BE with any grade of dysplasia 6 weeks after endoscopic resection 2. Prague Classification Score C≤3 and ≥M1 3. Patients should be ablation-naïve (no previous ablation therapy of the esophagus) 4. Older than 18 years of age at time of consent 5. Operable per institution's standards 6. Patient provides written informed consent on the IRB-approved informed consent form 7. Patient is willing and able to comply with follow-up requirements. Exclusion Criteria: 1. Esophageal stenosis preventing advancement of a therapeutic endoscope 2. Any endoscopically visualized lesion such as ulcers, masses or nodules. Neoplastic nodules must first be treated with ER ≥6 weeks prior to planned treatment under this protocol. 3. Prior ER of more than 2cm in length and/or \>50% of the esophageal lumen circumference 4. History of locally advanced (\>SM1) esophageal cancer 5. History of esophageal varices 6. Prior distal esophagectomy 7. Active esophagitis LA grade B or higher 8. Severe medical comorbidities precluding endoscopy 9. Uncontrolled coagulopathy 10. Pregnant or planning to become pregnant during period of study 11. Patient refuses or is unable to provide written informed consent 12. Participation in another study with investigational drug within the 30 days preceding or during the present study, interfering with participation in the current study 13. General poor health, multiple co-morbidities placing the patient at risk or otherwise unsuitable for trial participation
References
Publications (0)
Data not yet available
No reference posted for this study.