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Evaluation of Balloon-based Cryoablation of Human Esophageal Epithelium | Clinical Trials | Clareo Health

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Evaluation of Balloon-based Cryoablation of Human Esophageal Epithelium

NCT01293448•Pentax Medical

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate a cryoablation technique used to ablate human esophageal mucosa.

Detailed Description

The purpose of this study is to evaluate the histological results of a cryoablation technique used to ablate human esophageal mucosa. The performance and safety of the cryoablation technique will also be evaluated.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patient must have a minimum of 2.0 cm of non-ulcerated, non-inflammatory columnar-lined esophagus or squamous esophageal lined tissue suitable for ablation. A patient may be treated with up to 2 zones of ablation.
•Patient is 18 to 80 years of age at the time of consent (inclusive).
•Patient has provided written Informed Consent Form (IFC) using a form that has been approved by the Institution's reviewing IRB/EC.
•Patient is willing and able to comply with all Clinical Investigation Plan (CIP) requirements.
•Patient's esophagectomy is clinically necessary due to reasons unrelated to this study.
•Patient is deemed operable per standard institutional criteria.

Exclusion Criteria

•Patient has a known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to IFC, post treatment instructions or follow-up guidelines.
•Patient refuses or is unable to provide written informed consent. - -
•Patient has or is currently undergoing endoscopic ablation therapy within 4 cm from the proposed treatment area including, but not limited to cryospray therapy, laser treatment, photodynamic therapy, multi-polar electro coagulation, endoscopic mucosal resection, radiofrequency ablation or argon plasma coagulation.
•Patient has esophageal narrowing limiting access to the intended site of ablation.
•Patient is undergoing or has recently undergone chemotherapy (within 15 days or WBC below normal by institutional criteria or standards).
•Patient is undergoing or has recently undergone radiation therapy which involved the esophagus (within 15 days or WBC below normal by institutional criteria or standards).

Locations (4)

University of Southern California

Los Angeles, California, United States

University of Rochester

Rochester, New York, United States

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

AMC

Amsterdam, AZ, Netherlands

Key Dates

Start Date

December 1, 2010

Primary Completion Date

January 1, 2012

Completion Date

January 1, 2012

Last Updated

April 28, 2022

Enrollment

ACTUAL participants

Conditions

Barrett's EsophagusEsophageal Cancer

Interventions

Cryoballoon Ablation

DEVICE

Resilience and Equity in Aging, Cancer, and Health (REACH)

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Gastric CancerColon Cancer+4 more

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RECRUITINGPHASE3

Using 18F-FAPI PET to Detect Metastatic Disease in Patients That Have Gastric or Esophageal Cancer.

NCT07217704

Esophageal CancerGastric Cancer (GC)+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 28, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Evaluation of Balloon-based Cryoablation of Human Esophageal Epithelium

Inclusion Criteria

Exclusion Criteria

Resilience and Equity in Aging, Cancer, and Health (REACH)

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