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

NCT ID: NCT02729753

Last Updated: 2022-04-22

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2016-10-30

Brief Summary

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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

Detailed Description

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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.

Conditions

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Esophageal Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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CryoBalloon™ Full Ablation System

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

Group Type OTHER

CryoBalloon™ Full Ablation System

Intervention Type DEVICE

Tissue Ablation using CryoBalloon™ Full Ablation System

CryoBalloon™ Swipe Ablation System

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

Group Type OTHER

CryoBalloon™ Swipe Ablation System

Intervention Type DEVICE

Tissue Ablation using CryoBalloon™ Swipe Ablation System

Interventions

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CryoBalloon™ Full Ablation System

Tissue Ablation using CryoBalloon™ Full Ablation System

Intervention Type DEVICE

CryoBalloon™ Swipe Ablation System

Tissue Ablation using CryoBalloon™ Swipe Ablation System

Intervention Type DEVICE

Other Intervention Names

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CryoBalloon Ablation System (360) CryoBalloon Ablation System (90)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pentax Medical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Brian Louie, MD

Role: PRINCIPAL_INVESTIGATOR

Swedish Medical Center and Cancer Institute

Locations

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MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Swedish Medical Center and Cancer Institute

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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CP0014

Identifier Type: -

Identifier Source: org_study_id

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