trūFreeze® Spray Cryotherapy Patient Registry
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
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Subjects may be withdrawn prior to this for any of the following reasons: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 confidentiality, all subjects will be assigned a registry identification number, and
this will be the only link between subject identity and treatment information. Read-only
access will be provided to any personnel who is not an administrator or responsible for data
All data requested on the case report form must be recorded. All missing data must be
explained. The system allows sites to directly enter data electronically, however sites are
still responsible for ensuring they have source documents that support all data entered
electronically that are separate and verifiable. The registry system will maintain an audit
trail that captures when electronic entries are changed, what the change was, and who made
The investigators will ensure the capability for inspections of applicable registry-related
facilities (e.g. pharmacy, diagnostic laboratory, etc.). The registry will be monitored by
the sponsor, and allow auditing by the Institutional Review Board, government regulatory
bodies, and University compliance and quality assurance groups of all registry related
documents (e.g. source documents, regulatory documents, data collection instruments,
registry data, etc.).
Observational [Patient Registry]
Observational Model: Cohort, Time Perspective: Prospective
Collect efficacy and outcome data related to the use of trūFreeze® spray cryotherapy for treatment of unwanted tissue in the pulmonary and gastrointestinal settings.
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.
United States: Food and Drug Administration
|University of North Carolina at Chapel Hill||Chapel Hill, North Carolina 27599|
|Walter Reed National Military Medical Center||Bethesda, Maryland 20889|