VIATORR Device Registry

Launched by W.L.GORE & ASSOCIATES · Dec 13, 2022

Keywords

ClinConnect Summary

The VIATORR Device Registry is a clinical trial designed to study the safety and effectiveness of the GORE® VIATORR® TIPS Endoprosthesis, a device used to help patients with chronic liver disease. This trial aims to see how well the device works over a period of three years in real-world situations. Researchers will also gather information about how the treatment affects patients' quality of life after they receive the device.

To participate in this study, patients must be at least 18 years old and be eligible for the GORE® VIATORR® TIPS Endoprosthesis. They should also be able to follow the study requirements and provide informed consent, which means they understand what the study involves. Patients who are pregnant, breastfeeding, or currently involved in another research study cannot participate. If eligible, participants can expect regular check-ups and follow-ups to monitor their health and the device's performance throughout the trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patient is eligible for treatment with the GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion for TIPS creation
• • 2. Patient is ≥18 years of age
• • 3. Capable of complying with protocol requirements, including follow-up
• • 4. Signed informed consent by patient
• Exclusion Criteria:
• • 1. Unable or not willing to sign informed consent
• • 2. Patient is enrolled in an investigational study
• • 3. Patient has been previously enrolled in this registry
• • 4. Pregnant or breastfeeding female at time of informed consent signature
• • 5. Any other condition which in the judgement of the investigator would preclude adequate registry participation

Trial Officials