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
2 other identifiers
observational
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started May 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 29, 2017
CompletedFirst Submitted
Initial submission to the registry
July 3, 2017
CompletedFirst Posted
Study publicly available on registry
August 7, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 11, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2019
CompletedMarch 29, 2019
March 1, 2019
1.5 years
July 3, 2017
March 28, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Digital scale of image quality
Digital scale of image quality completed for each acquisition by the surgeon
up to 5 hours
Study Arms (1)
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.
Eligibility Criteria
Subjects who undergo surgery (orthopedic, urological or neurological surgery)
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital, Grenoble
Grenoble, 38700, France
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
Alexandre Moreau-Gaudry, MD, PhD
University Hospital, Grenoble
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 3, 2017
First Posted
August 7, 2017
Study Start
May 29, 2017
Primary Completion
December 11, 2018
Study Completion
January 30, 2019
Last Updated
March 29, 2019
Record last verified: 2019-03