Clinical Trial: trūFreeze® Spray Cryotherapy Patient Registry

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational [Patient Registry]

Official Title: trūFreeze® Spray Cryotherapy Patient Registry

Brief Summary: To collect efficacy and outcomes data related to the use of trūFreeze® spray cryotherapy for the treatment of unwanted tissue in the pulmonary and gastrointestinal settings.

Detailed Summary:

This is a prospective, multi-center registry of patients who are currently undergoing spray cryotherapy using the trūFreeze® device. The registry population consists of patients who are being treated using the spray cryotherapy trūFreeze® device for the removal of unwanted tissue, such as malignant or pre-malignant conditions in the pulmonary or gastrointestinal settings.

Patients eligible to participate in the registry will have disease and treatment specific data collected throughout therapy and long-term follow-up. Subjects will be considered to have completed the registry when data from the 5 year follow-up visit has been collected. The beginning of the follow-up period commences with the first endoscopic treatment session.

Subjects may be withdrawn prior to this for any of the following reasons:

  1. Death, or
  2. Lost to Follow-Up, or
  3. Withdrawal of consent, or
  4. Discontinuation by the investigator. Three attempts at contact using two different methods are required prior to determination that the subject is lost to follow-up. Attempts at contact must be with certified letters OR documented telephone contact.

The registry will utilize electronic case report forms using a web-based platform housed at the University of North Carolina at Chapel Hill. Access to the database will be limited to individuals involved in the research registry and will require a unique user ID and password. All access to the database and web-based application will be encrypted (HTTPS) and electronic systems compliant with applicable privacy and security regulations. To maintain patient confidentia
Sponsor: CSA Medical, Inc.

Current Primary Outcome: Collect efficacy and outcome data related to the use of trūFreeze® spray cryotherapy for treatment of unwanted tissue in the pulmonary and gastrointestinal settings. [ Time Frame: 5 years ]

The registry population consists of patients who are being treated using the trūFreeze® spray cryotherapy device for the removal of unwanted tissue, such as malignant or pre-malignant conditions in the pulmonary or gastrointestinal settings.


Original Primary Outcome: Same as current

Current Secondary Outcome: Collect safety data related to the use of trūFreeze® spray cryotherapy for treatment in the pulmonary and gastrointestinal settings. [ Time Frame: 5 years ]

All adverse events occurring during the registry period must be recorded. The clinical course of each event should be followed until resolution, stabilization, or until it has been determined that the registry treatment or participation is not the cause. Serious adverse events that are still ongoing at the end of the Spray Cryotherapy Patient Registry registry period must be followed up to determine the final outcome. Any serious adverse event that occurs after the registry period and is considered to be possibly related to the trūFreeze® spray cryotherapy device or registry participation should be recorded and reported immediately.


Original Secondary Outcome: Same as current

Information By: CSA Medical, Inc.

Dates:
Date Received: February 27, 2013
Date Started: April 2013
Date Completion: December 2018
Last Updated: May 10, 2017
Last Verified: May 2017