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Navitian Post-Market Clinical Follow-up Study
Multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study to confirm and support the clinical safety and performance of Navitian to meet EU Medical Device regulation (MDR) requirements in all the CONSECUTIVE patients treated with Navitian.
The objective of this multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study is to confirm and support the clinical safety and performance of the Navitian in a NON-SELECTED, Real World population under daily clinical practice when used as intended by the manufacturer to meet EU Medical Device regulation requirements for post-market clinical follow-up.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Centro Hospitalar Vila Nova de Gaia
Vila Nova de Gaia, Portugal
Hospital Universitari Vall D'Hebron
Barcelona, Spain
Hospital Clinic de Barcelona
Barcelona, Spain
Hospital Universitario Juan Ramon Jimenez
Huelva, Spain
Hospital Universitario de Leon
León, Spain
Hospital Universitario Lucus Agusti
Lugo, Spain
Hospital Universitario Marques de Valdecilla
Santander, Spain
Hospital Clinico Universitario de Valladolid
Valladolid, Spain
Start Date
September 26, 2022
Primary Completion Date
July 11, 2024
Completion Date
July 11, 2024
Last Updated
March 5, 2025
102
ACTUAL participants
Navitian
DEVICE
Lead Sponsor
Fundación EPIC
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05788432