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

Pentax Medical

Status: Completed

Conditions: Esophageal Cancer

Treatments: Device: CryoBalloon Ablation System

Study type: Interventional

Funder types: Industry

Identifiers

NCT02729727

CP-0008

Details and patient eligibility

About

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

Full 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.

Enrollment: 3 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3 participants in 1 patient group

Single Arm

Other group

Description:

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

Treatment:

Device: CryoBalloon Ablation System