Clinical Trials Directory

Trials / Completed

CompletedNCT04048694

Comparative Study of Calculating the X-ray Dose to the Skin of the Patient Exposed

Comparative Study of Calculating the Dose to the Skin by the Dosemap® Software and Its Measurement in Vivo by Gafchromic Movie

Status
Completed
Phase
Study type
Observational
Enrollment
100 (actual)
Sponsor
University Hospital, Brest · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The main objective is to estimate the precision of the calculation by the software DoseMap ® towards the in vivo measure by gafchromic movie.

Detailed description

The procedures of Interventional Cardiology are realized under exposure in the X-rays which can be sometimes important for the patient according to the nature of the procedure. The estimation of the dose in the skin following a procedure of interventional cardiology is difficult. The knowledge of this dose allows to anticipate the appearance of determinist effects, and so to activate a dermatological follow-up of the exposed patient in case of overtaking of a dose threshold. Unfortunately, it is impossible to measure it directly and the thresholds of exposures are fixed from the measure of the kerma in the air accumulated at the exit of the tube with X-ray, what remains very indistinct. Since a few years the manufacturers propose tools allowing an estimation of the dose the skin of the patient. The DoseMap software ® allows to consider this dose from the data of exposure supplied by the system. To do it, it uses a modelling simplified of the patient to feign the deposit of dose in the latter. It seems to us interesting to verify the precision of this simulation by comparing it with a measure of the in vivo dose.

Conditions

Timeline

Start date
2016-04-11
Primary completion
2016-10-27
Completion
2016-10-27
First posted
2019-08-07
Last updated
2019-08-07

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT04048694. Inclusion in this directory is not an endorsement.