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Enrolling By Invitation
NCT07639853
Case-Specific Health Care Professional Clinical Survey for Concerto Versa™ Detachable Coils
Conditions: Arteriovenous Malformation, Gastrointestinal Bleed, Gastric Varices, Hemorrhoid, Pelvic Venous Disorders, Peripheral Aneurysms, Portal Vein Embolization, Type II Endoleak, Varicocele, Hemorrhage
Sex: All
Ages: 22 Years – N/A
Healthy volunteers: No
Enrollment: 30
Sponsor: Medtronic Endovascular
Location: Del Sol Medical Center El Paso Texas
Summary
The purpose of the Case-Specific Health Care Professional (HCP) Clinical Survey for Concerto Versa™ Detachable Coils, also known as the Concerto Versa HCP Clinical Assessment, is to collect early clinical data from HCPs to assess clinical safety and performance of the Concerto Versa™ Detachable Coils, when used in accordance with approved device labeling per the Instructions for Use (IFU). Data collected will generate clinical evidence to quantitatively assess clinical safety and device performance for the purpose of obtaining European Union Medical Device Regulation (EU MDR) approval.
Eligibility Criteria
Inclusion Criteria:
1. Patient treated with Concerto Versa™ Detachable Coil is age ≥ 22 years at the time of procedure.
2. Use of Concerto Versa™ Detachable Coil in accordance with the device labeling.
3. Reporting of case within 72 hours of index procedure.
Source: ClinicalTrials.gov (NCT07639853). StuddyBuddy aggregates publicly available trial information.
