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

University Hospital, Grenoble24 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

C.Surgical Procedure

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subject having signed the non-objection form; * Requiring one of the following surgical procedures: * Urology: soft ureteroscopy, uteroscopy, sacral neuromodulation, JJ sent placement. * Orthopedics: vertebroplasty, gamma nail placement, sacro-iliac screw fixation. * Neurology: spinal surgery Exclusion Criteria: * Subject who refuse to participate in the study; * Who are under legal protection measure or unable to express their consent (guardianship, curatorship); * Deprived of liberty by judicial or administrative decision.

Locations (1)

University Hospital, Grenoble

Grenoble, France

Outcomes

Primary Outcomes

Digital scale of image quality

Digital scale of image quality completed for each acquisition by the surgeon

Time frame: up to 5 hours

Data from ClinicalTrials.gov

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