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

Completed

• Conditions: C.Surgical Procedure

• Registration Number: NCT03241290
• Lead Sponsor: University Hospital, Grenoble

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.

Study Timeline

• Study Start: 2017-05-29
• Study First Submitted: 2017-07-03
• Study First Submitted QC: 2017-08-04
• Study First Posted: 2017-08-07
• Primary Completion: 2018-12-11
• Study Completion: 2019-01-30
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-28
• Last Update Posted: 2019-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Digital scale of image quality	up to 5 hours	Digital scale of image quality completed for each acquisition by the surgeon

Trial Locations

Locations (1)

University Hospital, Grenoble; 🇫🇷 Grenoble, France