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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06174077
Other study ID # 7993
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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