Clinical Study to Evaluate the CryoBalloon™ Full and Swipe Ablation Systems for Ablation of Human Esophageal Epithelium
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Pentax Medical
- Enrollment
- 10
- Locations
- 2
- Primary Endpoint
- Safety of the CryoBalloon™ Full and Swipe Ablation System
Study Overview
Brief Summary
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
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Minimum of one 3cm area of non-ulcerated columnar-lined esophagus or squamous-lined tissue suitable for ablation
- •Older than 18 years of age
- •Requires a clinically necessary esophagectomy for esophageal cancer or other indications.
Exclusion Criteria
- •Patient has esophageal narrowing limiting access to the intended sites of ablation
Arms & Interventions
CryoBalloon™ Full Ablation System
To evaluate CryoBalloon™ Full Ablation System for the ablation of 360 degrees of human esophageal epithelium in patients scheduled to undergo esophagectomy.
Intervention: CryoBalloon™ Full Ablation System (Device)
CryoBalloon™ Swipe Ablation System
To evaluate CryoBalloon™ Swipe Ablation System for the ablation of 90 degrees of human esophageal epithelium in patients scheduled to undergo esophagectomy.
Intervention: CryoBalloon™ Swipe Ablation System (Device)
Outcomes
Primary Outcomes
Safety of the CryoBalloon™ Full and Swipe Ablation System
Time Frame: 2 weeks
Number of participants with serious, device-related adverse events after treatment with the CryoBalloon™ Swipe Ablation System
Effect of Ablation to Submucosa at Different Depth of Tissue Ablation Using the CryoBalloon™ Full and Swipe Ablation Systems
Time Frame: 2 weeks
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
Secondary Outcomes
- Device Performance: Average Procedure Time(Minutes from start to end of procedure)
- Device Performance: Ease of Deployment of Device(Minutes, from start to end of procedure)