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

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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03241290

Enrollment

Registered

2017-08-07

Start date

2017-05-29

Completion date

2019-01-30

Last updated

2019-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C.Surgical Procedure

Keywords

C-arm, Medical Imaging Device, Radiological

Brief 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.

Detailed 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Digital scale of image quality	up to 5 hours	Digital scale of image quality completed for each acquisition by the surgeon

Countries

France

Outcome results