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Subjects may be withdrawn prior to this for any of the following reasons:
- Death, or
- Lost to Follow-Up, or
- Withdrawal of consent, or
- 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 ]
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 ]
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