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RecruitingNCT06174077CIMVERUpdated Dec 18, 2023

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

An observational study in Vertebra Compression Fracture, sponsored by University Hospital, Strasbourg, France. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-18.

Sponsored by University Hospital, Strasbourg, France · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2023, 2 years 11 months ago, but the record still lists the study as recruiting.
  • Started Oct 2020; still recruiting 6 years 1 month later.
Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
30
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Vertebra Compression Fracture

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Keywords

  • Vertebra Compression Fracture
  • Vertebral cementoplasty
  • Fluoroscopy time
  • Fluoroscopic control
  • Single-level vertebral cementoplasty
03

In context

Fractures, Compression

50 studies on the registry are indexed under Fractures, Compression; 10 are open to participants now.

This study's planned enrollment of 30 is below the median of 100 across 16 observational studies indexed under Fractures, Compression.

Browse Fractures, Compression studies →

Lead sponsor

University Hospital, Strasbourg, France is the lead sponsor of 999 studies on the registry; 358 are open to participants now.

Browse University Hospital, Strasbourg, France studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
30 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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

07

Study locations

1 of 1 sites recruiting
  • Service d'Imagerie Interventionnelle - CHU de Strasbourg - France
    Strasbourg, 67091, France
    Recruiting
    • Roberto Luigi CAZZATO, MD · Contactrobertoluigi.cazzato@chru-strasbourg.fr · 33 3 69 55 16 35
    • Roberto Luigi CAZZATO, MD · Principal investigator
    • Ian LEONARD-LORANT, MD · Principal investigator
    • Afshin GANGI, MD, PhD · Sub investigator
    • Julien GARNON, MD · Sub investigator
    • Pierre AULOGE, MD · Sub investigator
    • Pierre DE MARINI, MD · Sub investigator
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Oct 2020 (actual). Primary completion is estimated for Dec 2023, 38 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 29, 2022
First posted
Dec 18, 2023
StartActual
Oct 6, 2020
Primary completionEst.
Dec 2023
CompletionEst.
Dec 31, 2023
Last update
Dec 18, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06174077
Lead sponsor
University Hospital, Strasbourg, France
Responsible party
Sponsor
First posted
Dec 18, 2023
Start date
Oct 6, 2020
Primary completion
Dec 2023 (estimated)
Completion
Dec 31, 2023 (estimated)
Last update
Dec 18, 2023

Study contacts

Roberto Luigi CAZZATO, MD
Contact
robertoluigi.cazzato@chru-strasbourg.fr
33 3 69 55 16 35

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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