Evaluation of Balloon-based Cryoablation of Human Esophageal Epithelium

Completed · Not applicable

Conditions studied: Barrett's Esophagus, Esophageal Cancer

In brief

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

Key facts

Study ID

NCT01293448

Run by

Pentax Medical

People needed

21

Starts

2010-12-01

Expected to finish

2012-01-01

Last updated by the study team

2022-04-28

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• 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

Full record on ClinicalTrials.gov

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