Actively Recruiting

Age: 2Years +
All Genders
NCT04927156

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

Led by Balt Extrusion · Updated on 2025-09-18

10000

Participants Needed

12

Research Sites

1055 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 2Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Provision of a signed, written and dated informed consent or non-opposition (where applicable)
Not Eligible

You will not qualify if you...

  • 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.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 12 locations

1

CHU Angers

Angers, France

Actively Recruiting

2

Chu Bordeaux

Bordeaux, France

Actively Recruiting

3

CHU Grenoble Alpes

La Tronche, France

Actively Recruiting

4

Hôpital Roger Salengro

Lille, France

Actively Recruiting

5

Kremlin Bicêtre - APHP

Paris, France

Actively Recruiting

6

Chu Tours

Tours, France, 37000

Actively Recruiting

7

Halle

Halle, Germany

Actively Recruiting

8

Hospital: Fundacion Jimenez Diaz

Madrid, Spain, 28222

Actively Recruiting

9

Hospital Clinico Universitario San Carlos

Madrid, Spain

Terminated

10

Unversitario Central de Asturias

Oviedo, Spain, 33011

Actively Recruiting

11

Hospital Universitario Marqués de Valdecilla (HUMV)

Santander, Spain

Actively Recruiting

12

Hospital Universitario Miguel Servet

Zaragoza, Spain

Not Yet Recruiting

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Research Team

C

Clinical Affairs Department

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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