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

Pentax Medical3 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Esophageal Cancer

Interventions

CryoBalloon Ablation SystemDEVICE

Tissue Ablation using CryoBalloon Ablation System

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Up to two (2) areas of 3 cm each non-ulcerated, columnar lined esophagus or squamous linted tissue suitable for ablation * Older than 18 years of age at the time of consent * Requires a clinically-necessary esophagectomy for esophageal cancer * Patient has provided written informed consent using the Informed Consent Form approved by the Institution's reviewing Medical Ethics Committee (MEC) Exclusion Criteria: * Patient refuses or is unable to provide written informed consent * Patient has esophageal narrowing limiting access to the intended site of ablation

Locations (1)

Academic Medical Centre Amsterdam

Amsterdam, North Holland, Netherlands

Outcomes

Primary Outcomes

Safety of CryoBalloon Ablation System

Incidence of device related serious adverse events

Time frame: through study completion, an average of 2 weeks

Secondary Outcomes

Device Performance

Ease of deployment of the CryoBalloon, procedure time, endoscope compatibility, device malfunction.

Time frame: through study completion, an average of 2 weeks

Data from ClinicalTrials.gov

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