Monitoring of Fluoroscopy Time on the Dose Delivered to the Patient During Vertebral Cementoplasty Procedures (CIMVER)

December 7, 2023 updated by: University Hospital, Strasbourg, France

Interest of Continuous Monitoring of the Fluoroscopy Time on the Dose Delivered to the Patient During Vertebral Cementoplasty Gestures With a Flat Panel Detector

The interventional radiology department of the Strasbourg University Hospital performs approximately 1,000 vertebral cementoplasties per year. This is one of the most practiced procedures in the department and therefore exposes the professionals in the room to significant annual cumulative doses of irradiation.

The objective of the study is to evaluate the interest of continuous visual monitoring of the fluoroscopy time by the operator on the dose delivered to the patient during an interventional radiology procedure performed under fluoroscopic control. The chosen reference examination is a single-level vertebral cementoplasty, a standardized examination that is frequent enough to allow easy data collection

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

30

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
      • Strasbourg, France, 67091
        • Recruiting
        • Service d'Imagerie Interventionnelle - CHU de Strasbourg - France
        • Sub-Investigator:
          • Afshin GANGI, MD, PhD
        • Sub-Investigator:
          • Julien GARNON, MD
        • Contact:
        • Principal Investigator:
          • Roberto Luigi CAZZATO, MD
        • Principal Investigator:
          • Ian LEONARD-LORANT, MD
        • Sub-Investigator:
          • Pierre AULOGE, MD
        • Sub-Investigator:
          • Pierre DE MARINI, 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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patient (≥18 years old) cared for at the HUS in interventional service for the realization of a vertebral cementoplasty of a single level

Description

Inclusion criteria:

  • Adult patient (≥18 years old)
  • Man or woman
  • Patient cared for at the HUS in interventional service for the realization of a vertebral cementoplasty of a single level between 01/06/2020 and 30/09/2020
  • Subject who has not expressed his opposition, after being informed, to the reuse of his data for the purposes of this research.

Exclusion criteria:

  • Patient who expressed their opposition to the reuse of their data for research purposes
  • Vertebroplasties of more than one level
  • History of spinal surgery or vertebroplasty near the level concerned

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Assess the interest of continuous visual monitoring of the fluoroscopy time by the operator on the dose delivered to the patient during an interventional radiology procedure performed under fluoroscopic control
Time Frame: up to 1 month
up to 1 month

Collaborators and Investigators

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

Sponsor

University Hospital, Strasbourg, France

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)

October 6, 2020

Primary Completion (Estimated)

December 1, 2023

Study Completion (Estimated)

December 31, 2023

Study Registration Dates

First Submitted

November 29, 2022

First Submitted That Met QC Criteria

December 7, 2023

First Posted (Actual)

December 18, 2023

Study Record Updates

Last Update Posted (Actual)

December 18, 2023

Last Update Submitted That Met QC Criteria

December 7, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7993

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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