Assessement of the C-ARM ARCO FP-Rk521 S in Surgical Conventional Practice

C.Surgical Procedure Clinical Trial

Official title: Prospective Assessment of the Quality of the Image and the Usability of the C-ARM ARCO FP-Rk521S Used in Surgical Conventional Practice

Status Completed

Clinical Trial Summary

THALES-EVAQUAL study assesses the quality of the images generated by C-ARM ARCO FP-Rk521S and its ability to be used during surgery.

Clinical Trial Description

Expected performance of TED developped technology compared to current equipment (intensifier tube) represent a significant improvement; especially in term of image rendering, irradiation dose reduction and ergonomy.

THALES-EVAQUAL is a prospective,monocentric, unrandomized, and uncontrolled study which objective is to assess C-ARM ARCO FP-Rk521S in term of quality of image. It also evaluates its ability to be used during Orthopedic, neurological and neurological surgeries.

Patient included in the study will have a surgery during which C-ARM is used. This study doesn't modify the medical care of the patient.

After each surgery, a digital scale of image quality will be filled by the surgeon for each aquisition. Other feedback questionnaires regarding the suitability of the device and the satisfaction of the surgeon will also be completed. ;

Related Conditions & MeSH terms

• C.Surgical Procedure

• NCT number: NCT03241290
• Study type: Observational
• Source: University Hospital, Grenoble
• Status: Completed
• Start date: May 29, 2017
• Completion date: January 30, 2019