CBAS180 De-escalation Study

Last updated: September 26, 2024
Sponsor: Koen Munters
Overall Status: Active - Recruiting

Phase

N/A

Condition

Barrett's Esophagus

Heartburn

Esophageal Disorders

Treatment

C2 CryoBalloon 180° Ablation System

Clinical Study ID

NCT05740189
NL73252.000.22
  • Ages > 18
  • All Genders

Study Summary

Evaluate the efficacy and safety of the C2 CryoBalloon 180° Ablatie Systeem (CBAS180) at decremental doses for the treatment of dysplastic Barrett's epithelium.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

  2. Diagnosis of LGD or HGD in BE (confirmed by BE expert pathologist) or;

  3. Residual BE with any grade of dysplasia after endoscopic resection (by means ofEMR or ESD) to treat non-flat BE, ≥6 weeks prior to enrolling the patient tothis study. The ER pathology should indicate endoscopic treatment (i.e. onlymucosal invasion or limited submucosal invasion (sm1), no lymphovascularinfiltration, free vertical resection margins and not poorly differentiated).

  4. Prague Classification Score of C≤3 and M≥1.

  5. Patients should be ablation-naïve, meaning they have not undergone any previousendoscopic ablation therapy of the esophagus.

  6. Older than 18 years of age at time of consent.

  7. Fit for endoscopic therapy per institution's standards.

  8. Provides written informed consent on the IRB-approved informed consent form.

  9. Willing and able to comply with follow-up requirements.

Exclusion

Exclusion Criteria:

  1. Esophageal stenosis preventing advancement of a therapeutic endoscope.

  2. Any endoscopically visualized lesion such as ulcers, masses or nodules. Neoplasticnodules must first be treated with ER ≥6 weeks prior to planned treatment under thisprotocol.

  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.

Study Design

Total Participants: 62
Treatment Group(s): 1
Primary Treatment: C2 CryoBalloon 180° Ablation System
Phase:
Study Start date:
February 19, 2023
Estimated Completion Date:
January 15, 2026

Study Description

Cryoballoon ablation is a relatively new ablation technique for the treatment of dysplastic Barrett's esophagus (BE). Previous studies with this technique have shown that treatment is safe and effective. When compared to other ablation techniques, cryoballon ablation has several potential advantages, including less pain and less complications such as stricture formation after treatment. Recently, a cryoballoon ablation system has become available which enables treatment of larger esophageal surfaces. Although a recent clinical study with this new device has shown promising results, the lowest possible dose that optimally balances safety and efficacy is still unknown.

This study is a multicenter, prospective, intervention study consisting of two phases: the treatment phase and the follow-up phase.

During the treatment phase, patients will undergo an upper endoscopy during which CBAS180 treatment will be performed. Treatment consists of two CBAS180 applications, starting just below the gastroesophageal junction (GEJ), resulting in a circumferential ablation of 3cm in length. During the treatment phase, two doses will be tested consecutively starting with the lowest dose (i.e. 1.2mm/sec). For each dose a total of 25 patients will be included. An interim analysis will be performed after treatment of the first 25 patients with the lowest dose of 1.2mm/sec, before proceeding to treatment of the additional 25 patients with a higher dose of 1.1mm/sec.

The follow-up phase starts after CBAS180 treatment and ends after first follow-up endoscopy at 10 weeks (±2 weeks) after treatment. Therefore, the study duration will be approximately 3 months for each individual patient. The investigators expect to report the primary outcome for all participating patients within 2 years.

Connect with a study center

  • Catharina Hospital

    Eindhoven, Noord-Brabant
    Netherlands

    Active - Recruiting

  • Amsterdam UMC

    Amsterdam, Noord-Holland
    Netherlands

    Active - Recruiting

  • St Antonius hospital

    Nieuwegein, Utrecht
    Netherlands

    Active - Recruiting

  • Erasmus MC

    Rotterdam, Zuid-Holland
    Netherlands

    Active - Recruiting

  • UMC Groningen

    Groningen,
    Netherlands

    Active - Recruiting

  • UMC Utrecht

    Utrecht,
    Netherlands

    Active - Recruiting

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