TAMBE Japan Post-Marketing Surveillance
Launched by W.L.GORE & ASSOCIATES ·
Trial Information
Current as of November 13, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a medical device called the TAMBE system, which is designed to treat a serious condition where a part of the large artery near the heart, called the thoracoabdominal aorta, becomes weakened and bulges out (known as an aneurysm). The goal of this study is to see how safe and effective this device is when used in real-world medical practice after it has already been approved for use.
The trial is open to all adults who have this type of aneurysm, although specific age details are not yet provided. Participants can expect to receive treatment using the TAMBE device, which includes a special graft that helps reinforce the weakened artery and restore normal blood flow. Since this study is still in the early stages and not yet recruiting, people interested should stay in touch with their doctors to learn more when the trial begins. This study is important because it helps doctors understand how well the TAMBE device works and how safe it is when used outside of tightly controlled research settings.
Gender
ALL
Eligibility criteria
About W.L.Gore & Associates
W.L. Gore & Associates is a pioneering medical device company renowned for its innovative contributions to the field of healthcare, particularly in vascular grafts, surgical meshes, and interventional devices. With a strong commitment to research and development, the company leverages advanced materials science to create products that enhance patient outcomes and improve the quality of care. W.L. Gore & Associates is dedicated to conducting clinical trials that rigorously evaluate the safety and efficacy of its products, ensuring compliance with regulatory standards and fostering collaboration with healthcare professionals worldwide. Through this commitment to excellence, the company aims to address unmet medical needs and advance the frontier of medical technology.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported