Safety, Performance and Usability of BALT Medical Devices: The EVIDENCE Post Marketing Clinical Follow-up Platform

Last updated: August 12, 2024
Sponsor: Balt Extrusion
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stroke

Peripheral Arterial Occlusive Disease

Circulation Disorders

Treatment

BALT medical devices

Clinical Study ID

NCT04927156
CIP-202002-BALT DEVICES
  • Ages > 2
  • All Genders

Study Summary

BALT has designed an electronic platform to continue collecting clinical data as part of the post-marketing clinical follow-up of its devices.

This platform is purely exploratory, without hierarchical order of the objectives and associated outcomes.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Provision of a signed, written and dated informed consent or non-opposition (where applicable)

Exclusion Criteria

  • Device(s) used in multiple procedures (two, or more, pathologies treated during the same procedure)

  • Contra-indications of each device as described in the instructions for use.

Study Design

Total Participants: 10000
Treatment Group(s): 1
Primary Treatment: BALT medical devices
Phase:
Study Start date:
July 12, 2021
Estimated Completion Date:
October 31, 2041

Connect with a study center

  • CHU Angers

    Angers,
    France

    Active - Recruiting

  • Chu Bordeaux

    Bordeaux,
    France

    Active - Recruiting

  • CHU Grenoble Alpes

    La Tronche,
    France

    Active - Recruiting

  • Hôpital Roger Salengro

    Lille,
    France

    Active - Recruiting

  • Kremlin Bicêtre - APHP

    Paris,
    France

    Active - Recruiting

  • Chu Tours

    Tours, 37000
    France

    Active - Recruiting

  • Halle

    Halle,
    Germany

    Site Not Available

  • Hospital Universitario de cruces

    Baracaldo, 48903
    Spain

    Site Not Available

  • Hospital Clinico Universitario San Carlos

    Madrid,
    Spain

    Active - Recruiting

  • Hospital: Fundacion Jimenez Diaz

    Madrid, 28222
    Spain

    Active - Recruiting

  • Hospital: Puerta de Hierro

    Madrid, 28222
    Spain

    Site Not Available

  • Unversitario Central de Asturias

    Oviedo, 33011
    Spain

    Active - Recruiting

  • Hospital Universitario Marqués de Valdecilla (HUMV)

    Santander,
    Spain

    Active - Recruiting

  • Hospital Universitario Miguel Servet

    Zaragoza,
    Spain

    Site Not Available

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