Esophageal Cancer Clinical Trial

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Clinical Study to Evaluate CryoBalloonâ„¢ Full and Swipe Ablation Systems for Ablation of Human Esophageal Epithelium

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Summary

This study will evaluate the C2 CryoBalloonâ„¢ 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

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Full Description

The primary outcomes for the study are the safety and treatment effect of the C2 CryoBalloonâ„¢ Ablation System. An esophagectomy will be performed as scheduled following the ablation procedure; histopathological analysis of surgically-resected specimens will be performed.

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Eligibility Criteria

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

Study is for people with:

Esophageal Cancer

Estimated Enrollment:

10

Study ID:

NCT02729753

Recruitment Status:

Completed

Sponsor:

Pentax Medical

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There are 2 Locations for this study

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MD Anderson Cancer Center
Houston Texas, 77030, United States
Swedish Medical Center and Cancer Institute
Seattle Washington, 98122, United States

How clear is this clinincal trial information?

Study is for people with:

Esophageal Cancer

Estimated Enrollment:

10

Study ID:

NCT02729753

Recruitment Status:

Completed

Sponsor:


Pentax Medical

How clear is this clinincal trial information?

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