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Completed

NCT Number: NCT03241290

Assessement of the C-ARM ARCO FP-Rk521 S 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital, Grenoble

Grenoble, 38700, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Digital scale of image quality

    Time frame: up to 5 hours

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

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Collaborators

  • Clinical Investigation Centre for Innovative Technology Network

Registry information

Official study title

Prospective Assessment of the Quality of the Image and the Usability of the C-ARM ARCO FP-Rk521S Used in Surgical Conventional Practice

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Aug 7, 2017
Registry last updated
Mar 29, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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