Evaluating a new cryoballoon treatment for Barrett's Esophagus

Clinical Trial to Evaluate Safety and Efficacy of the C2 Cryoballoon 180° Ablation System for the Treatment of Dysplastic Barrett's Esophagus: CBAS180 De-escalation Study

This study is testing a new cryoballoon treatment to see if it can safely help people with Barrett's esophagus feel better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 62 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: St. Antonius Hospital (Academic / other)
• Locations: 6 sites (Eindhoven, Noord-Brabant and 5 other locations)
• Trial ID: NCT05740189 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the efficacy and safety of the C2 CryoBalloon 180° Ablation System (CBAS180) for treating dysplastic Barrett's esophagus. The study involves a multicenter, prospective intervention approach, where patients will receive two consecutive doses of cryoballoon ablation during an upper endoscopy. The first phase will treat 25 patients with the lowest dose, followed by an interim analysis before treating an additional 25 patients with a higher dose. The follow-up phase will monitor patient outcomes post-treatment.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 with flat type Barrett's esophagus and an indication for ablation therapy.

Not a fit: Patients who have previously undergone endoscopic ablation therapy or have advanced disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a safer and more effective option for patients with dysplastic Barrett's esophagus.

How similar studies have performed: Previous studies using cryoballoon ablation have shown promising results, indicating potential for success with this new approach.

Eligibility criteria

Inclusion Criteria:

1. Flat type BE esophagus, with an indication for ablation therapy, defined as:

   1. Diagnosis of LGD or HGD in BE (confirmed by BE expert pathologist) or;
   2. Residual BE with any grade of dysplasia after endoscopic resection (by means of EMR or ESD) to treat non-flat BE, ≥6 weeks prior to enrolling the patient to this study. The ER pathology should indicate endoscopic treatment (i.e. only mucosal invasion or limited submucosal invasion (sm1), no lymphovascular infiltration, free vertical resection margins and not poorly differentiated).
2. Prague Classification Score of C≤3 and M≥1.
3. Patients should be ablation-naïve, meaning they have not undergone any previous endoscopic ablation therapy of the esophagus.
4. Older than 18 years of age at time of consent.
5. Fit for endoscopic therapy 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 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 \>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.

Where this trial is running

Eindhoven, Noord-Brabant and 5 other locations

• Catharina Hospital — Eindhoven, Noord-Brabant, Netherlands (Recruiting)
• Amsterdam UMC — Amsterdam, Noord-Holland, Netherlands (Recruiting)
• St Antonius hospital — Nieuwegein, Utrecht, Netherlands (Recruiting)
• Erasmus MC — Rotterdam, Zuid-Holland, Netherlands (Recruiting)
• UMC Groningen — Groningen, Netherlands (Recruiting)
• UMC Utrecht — Utrecht, Netherlands (Recruiting)

Study contacts

• Study coordinator: Koen Munters, Msc

Conditions Barrett's Esophagus; Ablation Therapy; Cryotherapy; Cryoballoon Ablation