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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
2028-06-30
Last Updated
2026-05-26
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 (9)
Klinikum Bad Hersfeld GmbH
Bad Hersfeld, Germany
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
Adana City Hospital
Adana, Turkey (Türkiye)
Ankara University Hospital
Ankara, Turkey (Türkiye)
Bilkent City Hospital
Ankara, Turkey (Türkiye)
Bilkent City Hospital
Ankara, Turkey (Türkiye)