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

Status: Recruiting
Location: See all (9) locations...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 85
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Germany
Klinikum Bad Hersfeld GmbH
RECRUITING
Bad Hersfeld
Italy
ASST Grande Ospedale Metropolitano Niguarda
RECRUITING
Milan
IRCCS Ospedale San Raffaele
RECRUITING
Milan
A.O.U. Città della Salute e Della Scienza di Torino
RECRUITING
Turin
Ospedale di Circolo
RECRUITING
Varese
Turkey
Adana City Hospital
RECRUITING
Adana
Ankara University Hospital
RECRUITING
Ankara
Bilkent City Hospital
RECRUITING
Ankara
Bilkent City Hospital
RECRUITING
Ankara
Contact Information
Primary
Rae Gong
gongrui@lifetechmed.com
(86-755)-86026250-6957
Time Frame
Start Date: 2024-06-21
Estimated Completion Date: 2028-06-30
Participants
Target number of participants: 132
Treatments
Cera Vascular Plug Subjects
Patients who need arterial or venous embolization in the peripheral vasculature.
Sponsors
Leads: Lifetech Scientific (Shenzhen) Co., Ltd.

This content was sourced from clinicaltrials.gov