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

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

Study Overview

• Status: Completed
• Conditions: C.Surgical Procedure

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.

• Study Type: Observational
• Enrollment (Actual): 24

Contacts and Locations

Study Locations

• France
  • Grenoble, France, 38700
    • University Hospital, Grenoble

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects who undergo surgery (orthopedic, urological or neurological surgery)

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Use of C-ARM ARCO FP-Rk521S; 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Collaborators: Clinical Investigation Centre for Innovative Technology Network

Publications and helpful links

Helpful Links

• Clinical Investigation Centre for Innovative Technology Network website

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 29, 2017
• Primary Completion (ACTUAL): December 11, 2018
• Study Completion (ACTUAL): January 30, 2019

Study Registration Dates

• First Submitted: July 3, 2017
• First Submitted That Met QC Criteria: August 4, 2017
• First Posted (ACTUAL): August 7, 2017

Study Record Updates

• Last Update Posted (ACTUAL): March 29, 2019
• Last Update Submitted That Met QC Criteria: March 28, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Radiological; C-arm; Medical Imaging Device
• Other Study ID Numbers: 38RC17.010; 2017-A00103-50 (OTHER: ID RCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No