Evaluation of Safety and Dose Response Using C2 CryoBalloon™ Swipe Ablation System for Barrett's Esophagus
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|ClinicalTrials.gov Identifier: NCT03097666|
Recruitment Status : Active, not recruiting
First Posted : March 31, 2017
Last Update Posted : September 14, 2018
|Condition or disease||Intervention/treatment||Phase|
|Barrett Esophagus||Device: C2 CRYOBALLOON SWIPE ABLATION SYSTEM||Not Applicable|
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 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 (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Patients with previously untreated (by means of ablation therapy) flat type Barrett's Esophagus (BE) (extent BE ≤C3) with Low-Grade Dysplasia (LGD) or High-Grade Dysplasia (HGD), or residual BE after removal of early adenocarcinoma|
|Masking:||None (Open Label)|
|Official Title:||Clinical Trial to Evaluate Safety and Dose Response Using the C2 CryoBalloon™ Swipe Ablation System for the Treatment of Barrett's Esophagus|
|Actual Study Start Date :||March 20, 2017|
|Estimated Primary Completion Date :||November 1, 2018|
|Estimated Study Completion Date :||November 1, 2018|
C2 Cryoballoon Swipe Ablation System
C2 Cryoballoon Swipe Ablation System
Device: C2 CRYOBALLOON SWIPE ABLATION SYSTEM
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.
- Dose-related SAEs [ Time Frame: 30 days ]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.
- Efficacy: Percent Eradication by therapeutic dose [ Time Frame: 8 weeks ]Eradication percentage of BE confirmed by histological evidence of eradication of BE, after treatment with the therapeutic dose.
- Incidence of AEs [ Time Frame: up to 30 days post-treatment ]Incidence of all serious and non-serious adverse events up to 30 days post-treatment.
- Post-procedure pain [ Time Frame: 24 hours and 7 days post-procedure ]Post-procedure pain in the area of the cryoablation treatment (scored on a 0 to 10 point VAS)
- Efficacy: Percent Regression [ Time Frame: 8 weeks ]Regression percentage at the first follow-up endoscopy, after 1 treatment with the therapeutic dose.
- Efficacy: Treatment [ Time Frame: 8 weeks ]Efficacy of treatment with CryoBalloon Swipe ablation system, defined as the proportion of patients with ≥80% regression of BE after 1 treatment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03097666
|AMC Medical Research B.V.|
|St. Antonius Hospital Nieuwegein|
|Catharina Ziekenhuis te Eindhoven|