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

Last updated: September 24, 2024
Sponsor: Lifetech Scientific (Shenzhen) Co., Ltd.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hepatic Fibrosis

Skin Wounds

Liver Disorders

Treatment

Cera™ Vascular Plug System

Clinical Study ID

NCT06099015
LT-TS-22CE-04-01
  • Ages 18-85
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. Aged 18 to 85;

  2. Life expectancy > 1 year;

  3. Require arterial or venous embolization in the peripheral vasculature;

  4. Target embolization site(s) allow for safe insertion of the delivery catheter;

  5. Voluntarily sign and date the Informed Consent Form (ICF) prior to any study-relatedactivities commencement;

  6. Willing and able to comply with protocol requirements, including all study visitsand procedures.

Exclusion

Exclusion Criteria:

  1. The subject is pregnant or plan to be pregnant or breast feeding;

  2. The subject has a known allergy or hypersensitivity to any of the device materialsincluding: nickel, stainless steel, polytetrafluoroethylene and titanium nitride;

  3. The subject has a known allergy or hypersensitivity to contrast agent;

  4. The subject has uncorrectable coagulopathy;

  5. The subject has planned use of anticoagulant (e.g. direct thrombin inhibitors,factor Xa inhibitors, vitamin K antagonists) or antiplatelet therapy before, duringand/or after treatment with the study device, which, in the opinion of theInvestigator, would clinically interfere with the study endpoints

  6. The subject has an unresolved systemic infection;

  7. Subject who cannot tolerate general or local anesthesia;

  8. The subject has a connective tissue disorders (e.g. Ehlers-Danlos Syndrome),arteritis (e.g. Takayasu's Disease) or another circulatory disorder;

  9. The subject is participating in other drug or medical device clinical trials;

  10. Any condition (medical or anatomic) making the subject not suitable fortranscatheter embolotherapy according to the opinion of the investigator.

Study Design

Total Participants: 132
Treatment Group(s): 1
Primary Treatment: Cera™ Vascular Plug System
Phase:
Study Start date:
June 21, 2024
Estimated Completion Date:
June 30, 2026

Study 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.

Connect with a study center

  • IRCCS Ospedale San Raffaele

    Milan,
    Italy

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.