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

Pentax Medical

Status: Completed

Conditions: Esophageal Cancer

Treatments: Device: CryoBalloon™ Full Ablation System; Device: CryoBalloon™ Swipe Ablation System

Study type: Interventional

Funder types: Industry

Identifiers

NCT02729753

CP0014

Details and patient eligibility

About

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

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

CryoBalloon™ Full Ablation System

Other group

Description:

To evaluate CryoBalloon™ Full Ablation System for the ablation of 360 degrees of human esophageal epithelium in patients scheduled to undergo esophagectomy.

Treatment:

Device: CryoBalloon™ Full Ablation System

CryoBalloon™ Swipe Ablation System

Other group

Description:

To evaluate CryoBalloon™ Swipe Ablation System for the ablation of 90 degrees of human esophageal epithelium in patients scheduled to undergo esophagectomy.

Treatment:

Device: CryoBalloon™ Swipe Ablation System