Evaluation of Effect of CryoBalloon Focal Ablation System on Human Esophageal Barrett's Epithelium

Completed

Conditions studied: Barrett's Esophagus

In brief

This is a feasibility study without a primary study hypothesis or statistical comparison.

Key facts

Study ID

NCT01633411

Run by

Pentax Medical

People needed

39

Starts

2011-12-01

Expected to finish

2014-06-01

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…

• Patients scheduled for ablation, EMR, and/or surveillance for BE (with or without dysplasia). Patient is 18 to 80 years of age at the time of consent (inclusive).
• Patient has provided written Informed Consent (IC) using an Informed Consent Form (ICF) 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 is deemed operable per standard institutional criteria.

You may not qualify if…

• Patient with endoscopically active inflammation in the treatment zone
• Esophageal stenosis preventing advancement of a therapeutic endoscope and/or within 4 cm of treatment zone.
• Patient has a known history of unresolved drug or alcohol dependency that would limit ability to comprehend or follow instructions related to informed consent, post treatment instructions or follow-up guidelines.
• Patient refuses or is unable to provide written informed consent.
• Patients that are pregnant.

Where it is running

• University of Southern California — Los Angeles, California, United States
• John Hopkins — Baltimore, Maryland, United States
• Columbia Medical Center — New York, New York, United States
• University of Rochester — Rochester, New York, United States
• Allegheny-Singer Research Institute — Pittsburgh, Pennsylvania, United States
• Academic Medical Center Amsterdam — Amsterdam, Netherlands
• St. Antonius Hospital — Nieuwegein, Netherlands
• Universitair Medisch Centrum Utrecht — Utrecht, Netherlands

Full record on ClinicalTrials.gov

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