Clinical Trials Directory

Trials / Recruiting

RecruitingNCT06099015

Cera™ Vascular Plug System Post-Market Clinical Follow-Up

Cera™ Vascular Plug System Post-Market Clinical Follow-Up: A Multi-center, Prospective, Observational, Single-arm, Open-label, Post-market Study

Status
Recruiting
Phase
—
Study type
Observational
Enrollment
132 (estimated)
Sponsor
Lifetech Scientific (Shenzhen) Co., Ltd. · Industry
Sex
All
Age
18 Years – 85 Years
Healthy volunteers
Not accepted

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

Detailed 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.

Conditions

Interventions

TypeNameDescription
DEVICECera™ Vascular Plug SystemThe 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.

Timeline

Start date
2024-06-21
Primary completion
2026-12-01
Completion
2027-12-01
First posted
2023-10-25
Last updated
2026-03-27

Locations

4 sites across 1 country: Italy

Source: ClinicalTrials.gov record NCT06099015. Inclusion in this directory is not an endorsement.