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Clinical Trial 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


Clinical Trial Description

Lifetech Cera™ Vascular Plug System is indicated for arterial and venous embolization in the peripheral vasculature. This study, planned under the MDR requirements, aims to confirm the safety and performance of the Lifetech Cera™ Vascular Plug System, identify previously unknown side-effects, monitor the identified side-effects (related to the procedures or to the medical devices), identify and analyse emergent risks. The Study intends to enroll 132 subjects. The estimated enrollment period is 1 year, and the expected duration of each subject's participation is 1 year (i.e., the follow-up period). Final report shall be completed in 2026. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06099015
Study type Observational
Source Lifetech Scientific (Shenzhen) Co., Ltd.
Contact Rae Gong
Phone (86-755)-86026250-6957
Email gongrui@lifetechmed.com
Status Not yet recruiting
Phase
Start date June 2024
Completion date June 2026

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