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

Grenoble Alpes University Hospital Center (CHU)

Status: Completed

Conditions: C.Surgical Procedure

Study type: Observational

Funder types: Other; NETWORK

Identifiers

NCT03241290

38RC17.010

2017-A00103-50 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

24 participants in 1 patient group

Use of C-ARM ARCO FP-Rk521S

Description:

C-ARM ARCO FP-Rk521S is mobile X-ray device that combines a X-Ray sensor and a sensor management software used during surgeries for real-time imaging.