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NCT06099015Recruiting

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

Source: ClinicalTrials.gov · Last updated 12 Jun 2026

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Study type
Observational
Enrollment
132 (estimated)
First submitted
17 Oct 2023
Start date
Jun 2024
Primary completion date
Jun 2027
Lead sponsor
Lifetech Scientific (Shenzhen) Co., Ltd.
NCT number
NCT06099015

What you commit to

  • Study type: Observational
  • Planned participants: 132
  • From Jun 2024 to the primary completion date, Jun 2027
  • 8 sites in 3 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • The subject has planned use of anticoagulant (e.g. direct thrombin inhibitors, factor Xa inhibitors, vitamin K antagonists) or antiplatelet therapy before, during and/or after treatment with the study device, which, in the opinion of the Investigator, would clinically interfere with the study endpoints
  • The subject is participating in other drug or medical device clinical trials;

Other illness

  • The subject has a known allergy or hypersensitivity to any of the device materials including: nickel, stainless steel, polytetrafluoroethylene and titanium nitride;
  • The subject has a known allergy or hypersensitivity to contrast agent;
  • The subject has an unresolved systemic infection;
  • The subject has a connective tissue disorders (e.g. Ehlers-Danlos Syndrome), arteritis (e.g. Takayasu's Disease) or another circulatory disorder;
  • Any condition (medical or anatomic) making the subject not suitable for transcatheter embolotherapy according to the opinion of the investigator.

Other

  • The subject is pregnant or plan to be pregnant or breast feeding;
  • The subject has uncorrectable coagulopathy;
  • Subject who cannot tolerate general or local anesthesia;

Who the study is looking for

  • Aged 18 to 85;
  • Life expectancy \> 1 year;
  • Require arterial or venous embolization in the peripheral vasculature;
  • Target embolization site(s) allow for safe insertion of the delivery catheter;
  • Voluntarily sign and date the Informed Consent Form (ICF) prior to any study-related activities commencement;
  • Willing and able to comply with protocol requirements, including all study visits and procedures.
  • Patients for whom the doctor has decided to use the Cera Vascular Plug System, regardless of the study.

Age in the registry: 18 years to 85 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (8)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Klinikum Bad Hersfeld GmbH
Coordinator of this site? Confirm its status
Bad HersfeldGermanyRecruiting
ASST Grande Ospedale Metropolitano Niguarda
Coordinator of this site? Confirm its status
MilanItalyRecruiting
IRCCS Ospedale San Raffaele
Coordinator of this site? Confirm its status
MilanItalyRecruiting
A.O.U. Città della Salute e della Scienza di Torino
Coordinator of this site? Confirm its status
TurinItalyRecruiting
Ospedale di Circolo
Coordinator of this site? Confirm its status
VareseItalyRecruiting
Adana City Hospital
Coordinator of this site? Confirm its status
AdanaTurkey (Türkiye)Recruiting
Bilkent City Hospital
Coordinator of this site? Confirm its status
AnkaraTurkey (Türkiye)Recruiting
Ankara University Hospital
Coordinator of this site? Confirm its status
AnkaraTurkey (Türkiye)Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.