Clinical trial · Interventional
Evaluation of Safety and Dose Response Using C2 CryoBalloon™ Swipe Ablation System for Barrett's Esophagus
Clinical Trial to Evaluate Safety and Dose Response Using the C2 CryoBalloon™ Swipe Ablation System for the Treatment of Barrett's Esophagus
NCT03097666CI-TRIAL-00057993completedN/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™ Swipe Ablation System ("CryoBalloon Swipe") used at increasing doses.
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 SWIPE ABLATION SYSTEM | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- C2 Cryoballoon Swipe Ablation System
- description
- C2 Cryoballoon Swipe Ablation System
- interventionNames
- Device: C2 CRYOBALLOON SWIPE ABLATION SYSTEM
Primary outcomes (2)
- measure
- 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.
- measure
- Efficacy: Percent Eradication by therapeutic dose
- timeFrame
- 8 weeks
- description
- Eradication percentage of BE confirmed by histological evidence of eradication of BE, after treatment with the therapeutic dose.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients with flat-type (Paris type 0-IIb) BE esophagus, with an indication for ablation therapy, meaning: * Diagnosis of LGD or HGD in BE (confirmed by baseline histopathological analysis), OR * Residual BE with any grade of dysplasia after endoscopic resection 2. Prague Classification Score C≤3 3. Patients should be ablative-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. Provides written informed consent on the IRB-approved informed consent form 7. Willing and able to comply with follow-up requirements Exclusion Criteria: 1. Esophageal stenosis or stricture preventing advancement of a therapeutic endoscope. 2. Any endoscopically visualized lesion such as ulcers, masses or nodules. 3. History of locally advanced (\>T1a) esophageal cancer 4. History of esophageal varices 5. Prior distal esophagectomy 6. Active esophagitis LA grade B or higher 7. Severe medical comorbidities precluding endoscopy 8. Uncontrolled coagulopathy 9. Pregnant or planning to become pregnant during period of study 10. Patient refuses or is unable to provide written informed consent 11. Participation in another study with investigational drug within the 30 days preceding or during the present study 12. General poor health, multiple co-morbidities placing the patient at risk or otherwise unsuitable for trial participation
References
Publications (1)
- DERIVEDSunakawa H, Yoda Y, Nonaka S, Suzuki H, Abe S, Ishiguro Y, Ikeno T, Wakabayashi M, Sato A, Nakajo K, Kadota T, Yano T. Prospective multicenter trial of the cryoballoon ablation system for superficial esophageal squamous cell carcinoma on post-endoscopic resection scars: a CRYO-SCAR study (EPOC1902). Gastrointest Endosc. 2024 Sep;100(3):429-437. doi: 10.1016/j.gie.2024.02.018. Epub 2024 Feb 29. PMID 38431103