Vascular Diseases Clinical Trial
Official title:
Clinical Validation and Evaluation of ClarityIQ Cardiac Image Processing for Cardiac Angiography and Intervention
Verified date | March 2022 |
Source | Philips Clinical & Medical Affairs Global |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
ClarityIQ is a novel X-ray imaging technology, that combines advanced real-time image noise reduction algorithms, with state-of-the-art hardware to reduce patient entrance dose significantly. This is realized by anatomy-specific optimization of the full acquisition chain (grid switch, beam filtering, pulse width, spot size, detector and image processing engine) for every clinical task individually. Furthermore, smaller focal spot sizes and shorter pulses are used, which are known to positively influence image quality . The final effect on the clinical image quality is investigated in this study.
Status | Completed |
Enrollment | 50 |
Est. completion date | November 2012 |
Est. primary completion date | November 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients older than 18 years of age undergoing coronary angiography Exclusion Criteria: - Patients not willing or unable to give consent to participate - Patients already involved in a clinical trial - Patients under the age of 18 - Pregnant women and breastfeeding women - Patients with severe kidney disease (eGFR < 60) |
Country | Name | City | State |
---|---|---|---|
Netherlands | Radboud University Nijmegen Medical Center | Nijmegen |
Lead Sponsor | Collaborator |
---|---|
Philips Clinical & Medical Affairs Global |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Radiation Dose Measurements: Air Kerma (AK) | Percentage of change of ClarityIQ vs. AlluraXper in Air Kerma (AK) calculated by AK/frame. Negative percentage means a reduction in dose for ClarityIQ vs. AlluraXper. | Participants were followed for the duration of the procedure | |
Primary | Image Quality | Overall proportion where diagnostic image quality of ClarityIQ is scored equal or better compared to AlluraXper by the blinded readers. Reading is performed by simultaneous visual comparison of the image quality of AlluraXper and ClarityIQ by multiple blinded reviewers.The images are presented in a randomized order.
The hypothesis is that the overall proportion where diagnostic image quality of ClarityIQ is scored equal or better is = than 0.80. Combined for all raters, the lower bound of the one-sided 95% CI (lower bound of the two-sided 90% CI)is used. |
1 day | |
Secondary | Radiation Dose Measurements: Dose Area Product (DAP) | Percentage of change of ClarityIQ vs. AlluraXper in Dose Area Product (DAP) calculated by DAP/frame. Negative percentage means a reduction in dose for ClarityIQ vs. AlluraXper. | Participants were followed for the duration of the procedure |
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