Trials / Completed
CompletedNCT03241290
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
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 24 (actual)
- Sponsor
- University Hospital, Grenoble · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Timeline
- Start date
- 2017-05-29
- Primary completion
- 2018-12-11
- Completion
- 2019-01-30
- First posted
- 2017-08-07
- Last updated
- 2019-03-29
Locations
1 site across 1 country: France
Source: ClinicalTrials.gov record NCT03241290. Inclusion in this directory is not an endorsement.