NCT01684826

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

September 1, 2012

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

September 11, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 13, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
1 year until next milestone

Results Posted

Study results publicly available

November 1, 2013

Completed
Last Updated

March 8, 2022

Status Verified

March 1, 2022

Enrollment Period

2 months

First QC Date

September 11, 2012

Results QC Date

August 26, 2013

Last Update Submit

March 7, 2022

Conditions

Vascular Diseases

Keywords

X-raysImage processingCardiovascular procedure

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Radiation Dose Measurements: Dose Area Product (DAP)

    Participants were followed for the duration of the procedure

Other Outcomes (1)

  • Radiation Dose Measurements: Air Kerma (AK)

    Participants were followed for the duration of the procedure

Study Arms (2)

ClarityIQ

EXPERIMENTAL

Angiographic run with new algorithm and low dose (50% dose)

Radiation: Angiographic run with new algorithm and low dose (50% dose)

AlluraXper

EXPERIMENTAL

Angiographic run with predecessor algorithm and dose (100% dose)

Radiation: Angiographic run with predecessor algorithm and dose (100%)

Interventions

Angiographic run with new algorithm and low dose (50% dose)RADIATION

Angiographic run with new algorithm and low dose (50% lower dose compared to Xper)

Also known as: ClarityIQ
ClarityIQ
Angiographic run with predecessor algorithm and dose (100%)RADIATION

Angiographic run with predecessor algorithm and dose (100% dose)

Also known as: AlluraXper
AlluraXper

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients older than 18 years of age undergoing coronary angiography

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud University Nijmegen Medical Center

Nijmegen, 6500HB, Netherlands

Location

MeSH Terms

Conditions

Vascular Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Results Point of Contact

Title
Frank Everaerts
Organization
Philips
frank.everaerts@philips.com
+31630728782

Study Officials

  • Harry Suryapranata, Prof Dr.

    Radboud University Nijmegen Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 11, 2012

First Posted

September 13, 2012

Study Start

September 1, 2012

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

March 8, 2022

Results First Posted

November 1, 2013

Record last verified: 2022-03

Locations

NL(1)