This study will evaluate the C2 CryoBalloon™ Full and Swipe Ablation Systems for the ablation of human esophageal epithelium in patients scheduled to undergo esophagectomy for reasons unrelated to the objective of the study
The primary outcomes for the study are the safety and treatment effect of the C2 CryoBalloon™ Ablation System. An esophagectomy will be performed as scheduled following the ablation procedure; histopathological analysis of surgically-resected specimens will be performed.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
10
Tissue Ablation using CryoBalloon™ Full Ablation System
Tissue Ablation using CryoBalloon™ Swipe Ablation System
MD Anderson Cancer Center
Houston, Texas, United States
Swedish Medical Center and Cancer Institute
Seattle, Washington, United States
Safety of the CryoBalloon™ Full and Swipe Ablation System
Number of participants with serious, device-related adverse events after treatment with the CryoBalloon™ Swipe Ablation System
Time frame: 2 weeks
Effect of Ablation to Submucosa at Different Depth of Tissue Ablation Using the CryoBalloon™ Full and Swipe Ablation Systems
Evaluated by depth and uniformity of ablation effect in the esophagus based on histopathologic assessment. Dose response by effect of ablation to submucosa: 0: Normal 1. Inflammatory cell infiltration 2. Separation with inflammation 3. Edema and Necrosis
Time frame: 2 weeks
Device Performance: Average Procedure Time
Average Procedure time as measured from start to finish of ablation.
Time frame: Minutes from start to end of procedure
Device Performance: Ease of Deployment of Device
Likert Scale measuring physician satisfaction. 0 (worst) to 10 (best)
Time frame: Minutes, from start to end of procedure
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