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


Sponsor

Lifetech Scientific (Shenzhen) Co., Ltd.

Enrollment

132 participants

Start Date

Jun 21, 2024

Study Type

OBSERVATIONAL

Conditions

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


Eligibility

Min Age: 18 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is following up on patients who have had a minimally invasive vascular procedure using the Cera Vascular Plug System — a small device used to block (embolize) blood vessels in the body when needed, such as to stop bleeding or prevent blood flow to a tumor or abnormal vessel. **You may be eligible if...** - You are between 18 and 85 years old - You need or have recently needed a procedure to block a blood vessel (arterial or venous embolization) in your peripheral vascular system - Your expected lifespan is more than 1 year - You are willing to attend follow-up visits as required by the study **You may NOT be eligible if...** - You are pregnant or planning to become pregnant - You are allergic to nickel, stainless steel, PTFE (a common plastic), titanium, or contrast dye - You have uncontrolled blood clotting problems - You have an active systemic infection - You cannot tolerate anesthesia - You have connective tissue disorders (like Ehlers-Danlos syndrome) or arterial inflammation conditions - You are participating in another medical device or drug trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICECera™ 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)

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NCT06099015


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