Actively Recruiting

Age: 18Years - 85Years
All Genders
NCT06099015

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

Led by Lifetech Scientific (Shenzhen) Co., Ltd. · Updated on 2026-04-23

132

Participants Needed

9

Research Sites

179 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 18 to 85 years
  • Life expectancy greater than 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 prior to any study-related activities
  • Willing and able to comply with all protocol requirements, including study visits and procedures
Not Eligible

You will not qualify if you...

  • Pregnant, planning to become pregnant, or breastfeeding
  • Known allergy or hypersensitivity to device materials including nickel, stainless steel, polytetrafluoroethylene, or titanium nitride
  • Known allergy or hypersensitivity to contrast agent
  • Uncorrectable coagulopathy
  • Planned use of anticoagulant or antiplatelet therapy that could interfere with study endpoints
  • Unresolved systemic infection
  • Unable to tolerate general or local anesthesia
  • Connective tissue disorders such as Ehlers-Danlos Syndrome, arteritis like Takayasu's Disease, or other circulatory disorders
  • Currently participating in other drug or medical device clinical trials
  • Any medical or anatomic condition making the subject unsuitable for transcatheter embolotherapy according to the investigator

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 9 locations

1

Klinikum Bad Hersfeld GmbH

Bad Hersfeld, Germany

Not Yet Recruiting

2

ASST Grande Ospedale Metropolitano Niguarda

Milan, Italy

Actively Recruiting

3

IRCCS Ospedale San Raffaele

Milan, Italy

Actively Recruiting

4

A.O.U. Città della Salute e Della Scienza di Torino

Turin, Italy

Actively Recruiting

5

Ospedale di Circolo

Varese, Italy

Actively Recruiting

6

Adana City Hospital

Adana, Turkey (Türkiye)

Actively Recruiting

7

Ankara University Hospital

Ankara, Turkey (Türkiye)

Actively Recruiting

8

Bilkent City Hospital

Ankara, Turkey (Türkiye)

Actively Recruiting

9

Bilkent City Hospital

Ankara, Turkey (Türkiye)

Actively Recruiting

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Research Team

R

Rae Gong

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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