Evaluate the efficacy and safety of the C2 CryoBalloon 180° Ablatie Systeem (CBAS180) at decremental doses for the treatment of dysplastic Barrett's epithelium.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
62
The C2 CryoBalloon 180° Ablation System is a cryosurgical device with a nitrous oxide cooled balloon probe that is compatible with upper gastrointestinal therapeutic endoscopes.
Catharina Hospital
Eindhoven, North Brabant, Netherlands
RECRUITINGAmsterdam UMC
Amsterdam, North Holland, Netherlands
RECRUITINGUMC Groningen
Groningen, Provincie Groningen, Netherlands
Efficacy: Dose response
Efficacy (dose response) will be evaluated by the BE surface regression percentage after 1 circumferential treatment session, as evaluated by the EGD-Adjudication Committee (EGD-AC) and confirmed by histological evidence of eradication of BE.
Time frame: 3 months
Safety: Incidence of Dose-related SAEs
Safety will be evaluated by the incidence of dose-related SAEs. Dose-related SAEs include pain in the treatment area greater than 6 (scored on a 0 to 10-point numeric rating scale (NRS)) at 24 hours post-treatment; symptomatic stricture requiring an additional EGD plus endoscopic dilation before first follow-up EGD; symptomatic stricture requiring endoscopic dilation at follow-up EGD; or any stricture (symptomatic or asymptomatic) preventing passage of the diagnostic endoscope at follow-up EGD.
Time frame: 24hours
Safety: Incidence of Dose-related SAEs
Safety will be evaluated by the incidence of dose-related SAEs. Dose-related SAEs include pain in the treatment area greater than 6 (scored on a 0 to 10-point numeric rating scale (NRS)) at 7 days post-treatment; symptomatic stricture requiring an additional EGD plus endoscopic dilation before first follow-up EGD; symptomatic stricture requiring endoscopic dilation at follow-up EGD; or any stricture (symptomatic or asymptomatic) preventing passage of the diagnostic endoscope at follow-up EGD.
Time frame: 7 days
Safety: Incidence of Dose-related SAEs
Safety will be evaluated by the incidence of dose-related SAEs. Dose-related SAEs include pain in the treatment area greater than 6 (scored on a 0 to 10-point numeric rating scale (NRS)) at 30 days post-treatment; symptomatic stricture requiring an additional EGD plus endoscopic dilation before first follow-up EGD; symptomatic stricture requiring endoscopic dilation at follow-up EGD; or any stricture (symptomatic or asymptomatic) preventing passage of the diagnostic endoscope at follow-up EGD.
Time frame: 30 days
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Erasmus MC
Rotterdam, South Holland, Netherlands
RECRUITINGSt Antonius hospital
Nieuwegein, Utrecht, Netherlands
RECRUITINGUMC Utrecht
Utrecht, Utrecht, Netherlands
RECRUITINGFeasibility: technical succes
Feasibility (technical success) defined as the percentage of patients in whom all BE could be treated as intended by the treating endoscopist.
Time frame: Directly after procedure
Post-procedural pain
Post-procedure pain in the area of the cryoablation treatment (scored on a 0 to 10-point numeric rating scale (NRS)), described as the median pain score directly after treatment.
Time frame: Directly after procedure
Post-procedural pain
Post-procedure pain in the area of the cryoablation treatment (scored on a 0 to 10-point numeric rating scale (NRS)), described as the median pain score 1 day after treatment.
Time frame: 24 hours
Post-procedural pain
Post-procedure pain in the area of the cryoablation treatment (scored on a 0 to 10-point numeric rating scale (NRS)), described as the median pain score 7 days after treatment.
Time frame: 7 days
Post-procedural pain
Post-procedure pain in the area of the cryoablation treatment (scored on a 0 to 10-point numeric rating scale (NRS)), described as the median pain score 30 days after treatment.
Time frame: 30 days
Post-procedure dysphagia
Post-procedure dysphagia (scored on a 0-4 dysphagia score), described as the median dysphagia score directly after treatment.
Time frame: Directly after procedure
Post-procedure dysphagia
Post-procedure dysphagia (scored on a 0-4 dysphagia score), described as the median dysphagia score 1 day after treatment.
Time frame: 24 hours
Post-procedure dysphagia
Post-procedure dysphagia (scored on a 0-4 dysphagia score), described as the median dysphagia score 7 days after treatment.
Time frame: 7 days
Post-procedure dysphagia
Post-procedure dysphagia (scored on a 0-4 dysphagia score), described as the median dysphagia score 30 days after treatment.
Time frame: 30 days
Incidence AE and SAE
Incidence of all serious and non-serious AEs up to 30 days post-treatment.
Time frame: 30 days
BE regression
BE surface regression percentage after 1 circumferential treatment session as assessed by the treating endoscopist.
Time frame: 3 months