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

Not Applicable

Completed

• Conditions: Esophageal Cancer
• Interventions: Device: CryoBalloon Ablation System

• Registration Number: NCT02729727
• Lead Sponsor: Pentax Medical

Brief 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.

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-03-14
• Study First Submitted QC: 2016-03-31
• Study First Posted: 2016-04-06
• Primary Completion: 2016-06-24
• Study Completion: 2016-06-30
• Status Verified: 2018-01
• Last Update Submitted: 2022-04-21
• Last Update Posted: 2022-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	CryoBalloon Ablation System	To evaluate safety and treatment effect of the CryoBalloon Ablation System for the Ablation of human esophageal epithelium in patients scheduled to undergo esophagectomy

Primary Outcome Measures

Name	Time	Method
Safety of CryoBalloon Ablation System	through study completion, an average of 2 weeks	Incidence of device related serious adverse events

Secondary Outcome Measures

Name	Time	Method
Device Performance	through study completion, an average of 2 weeks	Ease of deployment of the CryoBalloon, procedure time, endoscope compatibility, device malfunction.

Trial Locations

Locations (1)

Academic Medical Centre Amsterdam; 🇳🇱 Amsterdam, North Holland, Netherlands