The primary objective is to determine the safety and efficacy of the C2 CryoBalloon™ Swipe Ablation System ("CryoBalloon Swipe") used at increasing doses.
The procedure will be performed on an outpatient basis, and the CryoBalloon Swipe will be used for all ablations following the instructions for use provided with the product. Patients who meet the eligibility criteria will be assigned to one of the treatment groups and doses, depending on the order of their enrollment: In phase I, the first 6 patients will be treated with Dose 1 (lowest). All patients will have to undergo 8 week (±1 week) follow-up EGD to evaluate efficacy of the dose before the study continues. If the follow-up endoscopies show that Dose 1 eradicates ≥80% of the treated BE (by median percentage) and no SAE's are reported, this dose is defined as the therapeutic dose and enrollment will proceed to phase II. If Dose 1 eradicates \<80% of the treated BE, enrollment in Phase I will continue at the next highest dose. Treatment doses will be escalated in this manner until the earlier of a dose-related Serious Adverse Event (SAE) or determination of the therapeutic dose based on endoscopic exam. When the therapeutic dose is determined, the study will proceed to Phase II to generate additional safety and efficacy data. Phase II Phase II will confirm the safety and efficacy of the therapeutic dose found in Phase I. \--------------------------------------------------------------- Dose-related SAEs include pain in the treatment area greater than 6 (on VAS) on 24 hours and seven (7) days post-treatment; symptomatic stricture requiring an additional EGD with endoscopic dilation before the first follow-up EGD; symptomatic stricture at follow-up EGD; or any stricture (symptomatic or asymptomatic) preventing passage of the diagnostic endoscope at follow-up EGD. Any other serious adverse events within 30 days after treatment will also be evaluated by the Data and Safety Monitoring Board (DSMB) for relationship to the dose and severity. When a Dose-related serious adverse event occurs, the Holding Rule will be invoked and enrollment at that dose will be held until the DSMB has evaluated the event.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
The C2 CryoBalloon Swipe Ablation System ("CryoBalloon Swipe") is a cryosurgical device with a nitrous oxide cooled balloon probe that is compatible with upper gastrointestinal diagnostic endoscopes.
AMC Medical Research B.V.
Amsterdam, Netherlands
St. Antonius Hospital Nieuwegein
Amsterdam, Netherlands
Catharina Ziekenhuis te Eindhoven
Eindhoven, Netherlands
Dose-related SAEs
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.
Time frame: 30 days
Efficacy: Percent Eradication by therapeutic dose
Eradication percentage of BE confirmed by histological evidence of eradication of BE, after treatment with the therapeutic dose.
Time frame: 8 weeks
Incidence of AEs
Incidence of all serious and non-serious adverse events up to 30 days post-treatment.
Time frame: up to 30 days post-treatment
Post-procedure pain
Post-procedure pain in the area of the cryoablation treatment (scored on a 0 to 10 point VAS)
Time frame: 24 hours and 7 days post-procedure
Efficacy: Percent Regression
Regression percentage at the first follow-up endoscopy, after 1 treatment with the therapeutic dose.
Time frame: 8 weeks
Efficacy: Treatment
Efficacy of treatment with CryoBalloon Swipe ablation system, defined as the proportion of patients with ≥80% regression of BE after 1 treatment.
Time frame: 8 weeks
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