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

Vertebra Compression Fracture Clinical Trial

— CIMVER  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06174077
• Other study ID #: 7993
• Status: Recruiting
• Start date: October 6, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: December 2023
• Source: University Hospital, Strasbourg, France
• Contact: Roberto Luigi CAZZATO, MD
• Phone: 33 3 69 55 16 35
• Email: robertoluigi.cazzato[@]chru-strasbourg.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Compression
• Vertebra Compression Fracture

Locations

Country	Name	City	State
France	Service d'Imagerie Interventionnelle - CHU de Strasbourg - France	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		up to 1 month