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Cera™ Vascular Plug System Post-Market Clinical Follow-Up
Sponsor: Lifetech Scientific (Shenzhen) Co., Ltd.
Summary
The objective of the study is to collect and evaluate clinical data on patients of the Lifetech Cera™ Vascular Plug System to: * confirm the performance * confirm the safety * identify previously unknown side-effects * monitor the identified side-effects (related to the procedures or to the medical devices) * identify and analyse emergent risks
Official title: Cera™ Vascular Plug System Post-Market Clinical Follow-Up: A Multi-center, Prospective, Observational, Single-arm, Open-label, Post-market Study
Key Details
Gender
All
Age Range
18 Years - 85 Years
Study Type
OBSERVATIONAL
Enrollment
132
Start Date
2024-06-21
Completion Date
2027-12
Last Updated
2026-03-27
Healthy Volunteers
No
Conditions
Interventions
Cera™ Vascular Plug System
The Cera™ Vascular Plug System is composed of Cera™ Vascular Plug and its accessory Introducer Kit. The Cera™ Vascular Plug is a self-expandable, cylindrical Ni-Ti wire mesh device.
Locations (4)
ASST Grande Ospedale Metropolitano Niguarda
Milan, Italy
IRCCS Ospedale San Raffaele
Milan, Italy
A.O.U. Città della Salute e Della Scienza di Torino
Turin, Italy
Ospedale di Circolo
Varese, Italy