NCT03097666

Evaluation of Safety and Dose Response Using C2 CryoBalloon™ Swipe Ablation System for Barrett's Esophagus

Clinical Trial to Evaluate Safety and Dose Response Using the C2 CryoBalloon™ Swipe Ablation System for the Treatment of Barrett's Esophagus

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Pentax Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective is to determine the safety and efficacy of the C2 CryoBalloon™ Swipe Ablation System ("CryoBalloon Swipe") used at increasing doses.

Detailed description

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.

Conditions

• Barrett Esophagus

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-03-20
• Primary completion: 2018-11-01
• Completion: 2018-11-01
• First posted: 2017-03-31
• Last updated: 2022-04-22

Locations

3 sites across 1 country: Netherlands

Regulatory

• FDA-regulated device study