NCT02729727

Clinical Study to Evaluate CryoBalloon™ Ablation System in Patients Undergoing Esophagectomy

Clinical Study to Evaluate the CryoBalloon™ Full Ablation System for the Ablation of Human Esophageal Epithelium in Patients Undergoing Esophagectomy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: Pentax Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and treatment effect of the CryoBalloon™ Full Ablation System for the ablation of human esophageal epithelium in patients scheduled to undergo esophagectomy

Detailed description

The primary outcomes for the study are the safety and treatment effect of the CryoBalloon™ Ablation System. An esophagectomy will be performed as scheduled following the ablation procedure; histopathological analysis of surgically-resected specimens will be performed to determine the treatment effect.

Conditions

• Esophageal Cancer

Interventions

Type	Name	Description
DEVICE	CryoBalloon Ablation System	Tissue Ablation using CryoBalloon Ablation System

Timeline

• Start date: 2016-03-01
• Primary completion: 2016-06-24
• Completion: 2016-06-30
• First posted: 2016-04-06
• Last updated: 2022-04-28

Locations

1 site across 1 country: Netherlands