Clinical Study to Evaluate CryoBalloon™ Full and Swipe Ablation Systems for Ablation of Human Esophageal Epithelium

Not Applicable

Completed

• Conditions: Esophageal Cancer
• Interventions: Device: CryoBalloon™ Swipe Ablation System; Device: CryoBalloon™ Full Ablation System

• Registration Number: NCT02729753
• Lead Sponsor: Pentax Medical

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 Timeline

• Study First Submitted: 2016-03-09
• Study First Submitted QC: 2016-03-31
• Study Start: 2016-04
• Study First Posted: 2016-04-06
• Primary Completion: 2016-10-24
• Study Completion: 2016-10-30
• Results First Submitted: 2018-03-27
• Status Verified: 2018-09
• Results First Submitted QC: 2018-09-12
• Results First Posted: 2018-10-12
• Last Update Submitted: 2022-04-21
• Last Update Posted: 2022-04-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CryoBalloon™ Swipe Ablation System	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.
CryoBalloon™ Full Ablation System	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.

Primary Outcome Measures

Name	Time	Method
Safety of the CryoBalloon™ Full and Swipe Ablation System	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	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 Outcome Measures

Name	Time	Method
Device Performance: Average Procedure Time	Minutes from start to end of procedure	Average Procedure time as measured from start to finish of ablation.
Device Performance: Ease of Deployment of Device	Minutes, from start to end of procedure	Likert Scale measuring physician satisfaction. 0 (worst) to 10 (best)

Trial Locations

Locations (2)

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Swedish Medical Center and Cancer Institute; 🇺🇸 Seattle, Washington, United States