Status:
COMPLETED
Assessement of the C-ARM ARCO FP-Rk521 S in Surgical Conventional Practice
Lead Sponsor:
University Hospital, Grenoble
Collaborating Sponsors:
Clinical Investigation Centre for Innovative Technology Network
Conditions:
C.Surgical Procedure
Eligibility:
All Genders
18+ years
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 reductio...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 29 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 30 2019
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03241290
Start Date
May 29 2017
End Date
January 30 2019
Last Update
March 29 2019
Active Locations (1)
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1
University Hospital, Grenoble
Grenoble, France, 38700