NCT02729753

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Pentax Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Esophageal Cancer

Interventions

Type	Name	Description
DEVICE	CryoBalloon™ Full Ablation System	Tissue Ablation using CryoBalloon™ Full Ablation System
DEVICE	CryoBalloon™ Swipe Ablation System	Tissue Ablation using CryoBalloon™ Swipe Ablation System

Timeline

• Start date: 2016-04-01
• Primary completion: 2016-10-24
• Completion: 2016-10-30
• First posted: 2016-04-06
• Last updated: 2022-04-22
• Results posted: 2018-10-12

Locations

2 sites across 1 country: United States