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

February 15, 2023 updated by: Balt Extrusion

Safety, Performance and Usability of BALT Medical Devices: The EVIDENCE Post Marketing Clinical Follow-up Platform. An International, Multicenter, Prospective, and Retrospective Data Collection

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Angers, France
        • Recruiting
        • CHU Angers
        • Principal Investigator:
          • Anne PASCO PAPON, MD
      • La Tronche, France
        • Recruiting
        • CHU Grenoble Alpes
        • Principal Investigator:
          • Kamel Boubagra, MD
      • Lille, France
        • Recruiting
        • Hopital Roger Salengro
        • Principal Investigator:
          • Nicolas Bricout, MD
        • Sub-Investigator:
          • Estrade
      • Tours, France, 37000
        • Recruiting
        • Chu Tours
        • Contact:
          • Dr Bibi
        • Principal Investigator:
          • Dr Bibi
  • Spain
      • Madrid, Spain
        • Recruiting
        • Hospital Clínico Universitario San Carlos
        • Principal Investigator:
          • Dr Manu Moreu
      • Madrid, Spain, 28222
        • Recruiting
        • Hospital: Fundacion Jimenez Diaz
        • Principal Investigator:
          • Eduardo Crespo, MD
        • Principal Investigator:
          • Claudio Rodriguez, MD
      • Madrid, Spain, 28222
        • Not yet recruiting
        • Hospital: Puerta de Hierro
        • Principal Investigator:
          • Aurelio Vega, MD
        • Principal Investigator:
          • Rocio Gonzalez Costero, MD
      • Oviedo, Spain, 33011
        • Recruiting
        • Unversitario Central de Asturias
      • Santander, Spain
        • Recruiting
        • Hospital Universitario Marqués de Valdecilla (HUMV)
        • Principal Investigator:
          • Andrés Gonzalez Mandly, MD
      • Zaragoza, Spain
        • Not yet recruiting
        • Hospital Universitario Miguel Servet
        • Principal Investigator:
          • Santiago Guelbenzu, MD
        • Principal Investigator:
          • Joaquin Medrano, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

The study population will include the BALT medical devices under consideration used in their respective indications for use during interventions performed at the participating sites.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
BALT medical devices
Device: BALT medical devices

Includes, but is not limited to, the following:

  • Access devices
  • Aneurysm treatment devices
  • Ischemic Stroke and peripheral occlusive diseases treatment devices
  • Arterio-Venous Malformations/fistulas treatment devices

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of occurrence of device-specific safety indicator(s).
Time Frame: From the procedure to 12 months post-procedure depending on the device family.
Specific outcomes will be adapted accordingly for each device family since the intended use will vary according to the device families.
From the procedure to 12 months post-procedure depending on the device family.
Rate of devices achieving its intended use.
Time Frame: From the procedure to 12 months post-procedure depending on the device family.
Specific outcomes will be adapted accordingly for each device family since the intended use will vary according to the device families.
From the procedure to 12 months post-procedure depending on the device family.
Rate of devices achieving its specific performance indicator(s).
Time Frame: From the procedure to 12 months post-procedure depending on the device family.
Specific outcomes will be adapted accordingly for each device family since the intended use will vary according to the device families.
From the procedure to 12 months post-procedure depending on the device family.
Rate of devices in each category of the usability scale (Likert-type scale) for each usability indicator
Time Frame: From the procedure to 12 months post-procedure depending on the device family.
Qualitative measurement of usability for each usability indicator (i.e., good, well adapted, fairly adapted, bad). Specific outcomes will be adapted accordingly for each device family since the intended use will vary according to the device families.
From the procedure to 12 months post-procedure depending on the device family.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Balt Extrusion

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 12, 2021

Primary Completion (Anticipated)

June 1, 2041

Study Completion (Anticipated)

October 1, 2041

Study Registration Dates

First Submitted

June 9, 2021

First Submitted That Met QC Criteria

June 14, 2021

First Posted (Actual)

June 15, 2021

Study Record Updates

Last Update Posted (Estimate)

February 16, 2023

Last Update Submitted That Met QC Criteria

February 15, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIP-202002-BALT DEVICES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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