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Completed

NCT Number: NCT00747448

CryoSpray Ablation (TM) GI Patient Registry

The purpose of this study is to create a patient registry to collect and analyze post-510K approval information on subjects treated endoscopically with the CryoSpray Ablation™ System.

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Key information

Conditions

Barrett's Esophagus Barrett Esophagus Digestive System Diseases Digestive System Neoplasms Esophageal Cancer Esophageal Diseases Esophageal Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Neoplasms Neoplasms by Site Precancerous Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Scripps Research Institute, La Jolla, California, United States

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About this study

The proposed registry is a prospective, multi-center study of patients that are being currently undergoing CryoSpray Ablation™. It will also be used to catalogue retrospective data from records of patients already treated with the device. A maximum of 40 investigational sites will participate in this study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The study population consists of patients who are being treated, or were treated, with the CryoSpray Ablation™ System for malignant or pre-malignant conditions of the esophagus, including:
  • Barrett's esophagus with or without dysplasia
  • Squamous dysplasia of the esophagus
  • Esophageal cancer, any stage

Exclusion criteria

  • Subjects with esophageal lesions whose pathology was not one of the above.
  • Subjects with one of the above conditions who were not treated with the CryoSpray Ablation™ System.

Treatment and study plan

Primary outcomes

  1. Primary objectives of the study are to enable analysis of patient outcomes 2 years after final treatment and report on the effectiveness of the device in eradicating, decreasing or downgrading of the lesions.

    Time frame: 2 years post treatment

Sponsors and collaborators

Lead sponsor

CSA Medical, Inc.

Industry

Registry information

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Sep 5, 2008
Registry last updated
Feb 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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