Coronary Artery DiseaseRADIQALNCT06944509
RADIQAL Study (Radiation Dose and Image Quality Trial)
A study testing treatment with the Azurion system with Xres5 and Azurion with Clairy IQ in people with Coronary Artery Disease, run by Philips Clinical & Medical Affairs Global at 6 sites in 4 countries.
Trial summary
The Azurion R4.0 is developed by Philips Medical Systems Nederland B.V., a Philips Healthcare company. The Azurion is an interventional X-ray system which is used for live X-ray imaging during invasive cardiac procedures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- treatment with the Azurion system with Xres5 and Azurion with Clairy IQ
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 824 participants
- Where
- 6 sitesin 4 countries
- Study dates
- 14 May 2025to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject will be undergoing a diagnostic angiography and/or coronary intervention /elective PCI.
- Subject is able to give written informed consent.
- Subject is 18 years of age or older, or of legal age to give informed consent per state or national law.
Who cannot join
- Subject with known contrast allergy that cannot be adequately premedicated.
- Subject with previous contraindication for diagnostic angiography and/or diagnostic/elective PCI.
- Subject participates in a potentially confounding drug or device study during the course of the study.
- All vulnerable subjects such as pregnant or breast-feeding women, or any other subject who meets an exclusion criteria according to applicable national laws, if any.
- Subject unwilling or unable to comply with the protocol and/or unable to understand verbal and/or written informed consent.
- Expected use of non-standard contrast concentrations (e.g. dilution of contrast).
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
United States3 sites
Emory University Hospital
Atlanta, Georgia, 30322
University of Colorado
Denver, Colorado, 80204
NYP Columbia
New York, New York, 80045
About this study
The Azurion R4.0 is developed by Philips Medical Systems Nederland B.V., a Philips Healthcare company. The Azurion is an interventional X-ray system which is used for live X-ray imaging during invasive cardiac procedures. The proposed Azurion R4.0 includes new x-ray image postprocessing (Xres5) compared to its predecessor, which was equipped with ClarityIQ image post-processing (Xres4).
Azurion R4.0 is a cleared device for EU-MDR regulated countries, submission for FDA510K clearance in the US is pending. Sites in the US will only be activated in the study after FDA clearance.
Read more
This is a prospective, randomized, unblinded, comparative, international, multi-center clinical investigation. Randomization will be 1:1 between Xres5 and ClarityIQ (Xres4). Stratification will be performed per site on intended procedure type (based on clinical presentation) and patient BMI.
Primary objective is to demonstrate that in coronary procedures, Xres5 can reduce overall patient radiation dose compared to the current ClarityIQ without affecting procedural performance.
It is expected that 824 subjects are necessary to collect sufficient data for the evaluation of the objectives of this clinical study. The enrollment period is expected to last for 12 months. The study will be executed in Spain, Czech republic, Denmark and the US.
Read the detailed description
The study procedures consist of three main steps: 1) patient screening and written informed consent, 2) baseline assessment and randomization and 3) treatment with the Azurion system with Xres5 [intervention] or the standard of care (ClarityIQ/Xres4) [control]. Patients will be randomly assigned to either the intervention group or the control group (using the standard of care) in a 1:1 ratio. The coronary procedure will be conducted as per institutional standards and at the discretion of the operator, but the standard image processing will be based on the randomization result. If randomized to the intervention group (Xres5), it will always be possible for the operator to cross over to the standard of care imaging processing (Clarity IQ). For the study sites in EU the primary staff in the intervention room will be wearing electronic staff dosimeters which will log the radiation exposure per staff member per procedure.
After the procedure, characteristics of the patient and procedure are captured in an eCRF. The imaging runs will be uploaded in the cloud after de-identification. After the study the radiation dose (DAP and Air Kerma) will be read out from the system.
The study procedures will end after the coronary procedure is completed. There will be no modifications in the standard of care patient treatment or follow-up.
- Conditions
- Coronary Artery Disease
- Being tested
- treatment with the Azurion system with Xres5, Azurion with Clairy IQ
- Keywords
- invasive diagnostic procedures, diagnostic coronary angiographies, percutaneous coronary interventions, invasive coronary angiography, coronary artery disease
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
treatment with the Azurion system with Xres5Device
treatment with the Azurion system with Xres5
Azurion with Clairy IQOther
Azurion system with the standard of care (ClarityIQ/Xres4)
| Study group | Role | What they receive |
|---|---|---|
| Intervention (Xres5) | Experimental | treatment with the Azurion system with Xres5 Receives: Device: treatment with the Azurion system with Xres5 |
| Control (ClarityIQ) | Active comparator | the standard of care (ClarityIQ/Xres4) Receives: Other: Azurion with Clairy IQ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient radiation dose and procedural performance (ClarityIQ vs Xres5)
- Cumulative Dose Area Product (DAP) [Gycm2]
Total patient group - All procedure types
Measured: during study procedure
Patient radiation dose and procedural performance (ClarityIQ vs Xres5)
- Cumulative Air Kerma (AK) [Gy]
Total patient group - All procedure types
Measured: during study procedure
Patient radiation dose and procedural performance (ClarityIQ vs Xres5)
- Time System in Use* [minutes]
Total patient group - All procedure types
Measured: during study procedure
Secondary outcomes (16)
Patient radiation dose and procedural performance - High BMI (ClarityIQ vs Xres5)
- Cumulative DAP [Gycm2]
High BMI patients (BMI ≥ 30 kg/m2) - All procedures types
Measured: During study procedure
Patient radiation dose and procedural performance - High BMI (ClarityIQ vs Xres5)
- Cumulative Air Kerma [Gy]
High BMI patients (BMI ≥ 30 kg/m2) - All procedures types
Measured: During study procedure
Patient radiation dose and procedural performance - High BMI (ClarityIQ vs Xres5)
- Time System in Use* [minutes]
High BMI patients (BMI ≥ 30 kg/m2) - All procedures types
Measured: During study procedure
Patient radiation dose and procedural performance in diagnostic procedures (ClarityIQ vs Xres5)
- Cumulative DAP [Gycm2]
Total patient group - ICA procedures
Measured: During study procedure
Patient radiation dose and procedural performance in diagnostic procedures (ClarityIQ vs Xres5)
- Cumulative Air Kerma [Gy]
Total patient group - ICA procedures
Measured: During study procedure
Patient radiation dose and procedural performance in diagnostic procedures (ClarityIQ vs Xres5)
- Time System in Use* [minutes]
Total patient group - ICA procedures
Measured: During study procedure
Patient radiation dose and procedural performance in interventional procedures (ClarityIQ vs Xres5)
- Cumulative DAP [Gycm2]
Total patient group - PCI and ICA+PCI procedures
Measured: During study procedure
Patient radiation dose and procedural performance in interventional procedures (ClarityIQ vs Xres5)
- Cumulative Air Kerma [Gy]
Total patient group - PCI and ICA+PCI procedures
Measured: During study procedure
Patient radiation dose and procedural performance in interventional procedures (ClarityIQ vs Xres5)
- Time System in Use* [minutes]
Total patient group - PCI and ICA+PCI procedures
Measured: During study procedure
Coronary Cine Radiation Dose and procedural performance (ClarityIQ vs Xres5)
- Cumulative Cine Air Kerma [Gy]
Total patient group - All procedure types - Coronary Cine Data
Measured: During study procedure
Coronary Cine Radiation Dose and procedural performance (ClarityIQ vs Xres5)
- Cumulative Cine DAP [Gycm2]
Total patient group - All procedure types - Coronary Cine Data
Measured: During study procedure
Coronary Cine Radiation Dose and procedural performance (ClarityIQ vs Xres5)
- Time System in Use* [minutes]
Total patient group - All procedure types - Coronary Cine Data
Measured: During study procedure
Coronary Cine Radiation Dose and procedural performance - High BMI (ClarityIQ vs Xres5)
- Cumulative Cine Air Kerma [Gy]
High BMI patients (BMI ≥ 30 kg/m2) - All procedure types - Coronary Cine Data
Measured: During study procedure
Coronary Cine Radiation Dose and procedural performance - High BMI (ClarityIQ vs Xres5)
- Cumulative Cine DAP [Gycm2]
High BMI patients (BMI ≥ 30 kg/m2) - All procedure types - Coronary Cine Data
Measured: During study procedure
Coronary Cine Radiation Dose and procedural performance - High BMI (ClarityIQ vs Xres5)
- Time System in Use* [minutes]
High BMI patients (BMI ≥ 30 kg/m2) - All procedure types - Coronary Cine Data
Measured: During study procedure
Ultra-low dose cine fluoro rate (Xres5)
- Air Kerma rate per acquisitions [mGy/minutes]
Xres5 cases - Total Patient group - All procedure types
Measured: During study procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2025
- Study start14 May 2025
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective, randomized, unblinded, comparative, international, multi-center clinical investigation.
- Masking
- None (open label)
- Enrolment
- 824 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Philips Clinical & Medical Affairs Global
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06944509
- Sponsor's protocol ID
- IGT-200140-RADIQAL
- Acronym
- RADIQAL
- Status last verified
- Jun 2026
- First submitted
- 7 Apr 2025
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Philips Medical Systems Nederland B.V., "Safety and feasibility study with a new X-ray processing algorithm (Xres5) for coronary procedures"
Gislason-Lee AJ, Keeble C, Malkin CJ, Egleston D, Bexon J, Kengyelics SM, Blackman D, Davies AG. Impact of latest generation cardiac interventional X-ray equipment on patient image quality and radiation dose for trans-catheter aortic valve implantations. Br J Radiol. 2016 Nov;89(1067):20160269. doi: 10.1259/bjr.20160269. Epub 2016 Sep 29.
PubMed 27610932Nakamura S, Kobayashi T, Funatsu A, Okada T, Mauti M, Waizumi Y, Yamada S. Patient radiation dose reduction using an X-ray imaging noise reduction technology for cardiac angiography and intervention. Heart Vessels. 2016 May;31(5):655-63. doi: 10.1007/s00380-015-0667-z. Epub 2015 Apr 4.
PubMed 25840815Hruby A, Hu FB. The Epidemiology of Obesity: A Big Picture. Pharmacoeconomics. 2015 Jul;33(7):673-89. doi: 10.1007/s40273-014-0243-x.
PubMed 25471927Smith IR, Rivers JT. Measures of radiation exposure in cardiac imaging and the impact of case complexity. Heart Lung Circ. 2008 Jun;17(3):224-31. doi: 10.1016/j.hlc.2007.10.004. Epub 2008 Jan 31.
PubMed 18242136Cusma JT, Bell MR, Wondrow MA, Taubel JP, Holmes DR Jr. Real-time measurement of radiation exposure to patients during diagnostic coronary angiography and percutaneous interventional procedures. J Am Coll Cardiol. 1999 Feb;33(2):427-35. doi: 10.1016/s0735-1097(98)00591-9.
PubMed 9973023Fetterly KA, Lennon RJ, Bell MR, Holmes DR Jr, Rihal CS. Clinical determinants of radiation dose in percutaneous coronary interventional procedures: influence of patient size, procedure complexity, and performing physician. JACC Cardiovasc Interv. 2011 Mar;4(3):336-43. doi: 10.1016/j.jcin.2010.10.014.
PubMed 21435613
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RADIQAL Study (Radiation Dose and Image Quality Trial)
- ClinicalTrials.gov ID
- NCT06944509
- Acronym / sponsor ID
- RADIQAL / IGT-200140-RADIQAL
- Conditions
- Coronary Artery Disease
- Keywords
- invasive diagnostic procedures, diagnostic coronary angiographies, percutaneous coronary interventions, invasive coronary angiography, coronary artery disease
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 824 participants (estimated)
- Lead sponsor
- Philips Clinical & Medical Affairs GlobalIndustry (pharma, biotech, devices)
- Study start
- 14 May 2025 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 25 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Azurion R4.0 is developed by Philips Medical Systems Nederland B.V., a Philips Healthcare company. The Azurion is an interventional X-ray system which is used for live X-ray imaging during invasive cardiac procedures. The proposed Azurion R4.0 includes new x-ray image postprocessing (Xres5) compared to its predecessor, which was equipped with ClarityIQ image post-processing (Xres4).
Azurion R4.0 is a cleared device for EU-MDR regulated countries, submission for FDA510K clearance in the US is pending. Sites in the US will only be activated in the study after FDA clearance.
This is a prospective, randomized, unblinded, comparative, international, multi-center clinical investigation. Randomization will be 1:1 between Xres5 and ClarityIQ (Xres4). Stratification will be performed per site on intended procedure type (based on clinical presentation) and patient BMI.
Primary objective is to demonstrate that in coronary procedures, Xres5 can reduce overall patient radiation dose compared to the current ClarityIQ without affecting procedural performance.
It is expected that 824 subjects are necessary to collect sufficient data for the evaluation of the objectives of this clinical study. The enrollment period is expected to last for 12 months. The study will be executed in Spain, Czech republic, Denmark and the US.
Detailed description
The study procedures consist of three main steps: 1) patient screening and written informed consent, 2) baseline assessment and randomization and 3) treatment with the Azurion system with Xres5 [intervention] or the standard of care (ClarityIQ/Xres4) [control]. Patients will be randomly assigned to either the intervention group or the control group (using the standard of care) in a 1:1 ratio. The coronary procedure will be conducted as per institutional standards and at the discretion of the operator, but the standard image processing will be based on the randomization result. If randomized to the intervention group (Xres5), it will always be possible for the operator to cross over to the standard of care imaging processing (Clarity IQ). For the study sites in EU the primary staff in the intervention room will be wearing electronic staff dosimeters which will log the radiation exposure per staff member per procedure.
After the procedure, characteristics of the patient and procedure are captured in an eCRF. The imaging runs will be uploaded in the cloud after de-identification. After the study the radiation dose (DAP and Air Kerma) will be read out from the system.
The study procedures will end after the coronary procedure is completed. There will be no modifications in the standard of care patient treatment or follow-up.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a prospective, randomized, unblinded, comparative, international, multi-center clinical investigation.
| Arm | Type | Receives |
|---|---|---|
| Intervention (Xres5) | Experimental | Device: treatment with the Azurion system with Xres5treatment with the Azurion system with Xres5 |
| Control (ClarityIQ) | Active comparator | Other: Azurion with Clairy IQthe standard of care (ClarityIQ/Xres4) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject will be undergoing a diagnostic angiography and/or coronary intervention /elective PCI.
- Subject is able to give written informed consent.
- Subject is 18 years of age or older, or of legal age to give informed consent per state or national law.
Key exclusion criteria (6 listed)
- Subject with known contrast allergy that cannot be adequately premedicated.
- Subject with previous contraindication for diagnostic angiography and/or diagnostic/elective PCI.
- Subject participates in a potentially confounding drug or device study during the course of the study.
- All vulnerable subjects such as pregnant or breast-feeding women, or any other subject who meets an exclusion criteria according to applicable national laws, if any.
- Subject unwilling or unable to comply with the protocol and/or unable to understand verbal and/or written informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| treatment with the Azurion system with Xres5treatment with the Azurion system with Xres5 | Device | Intervention (Xres5) |
| Azurion with Clairy IQAzurion system with the standard of care (ClarityIQ/Xres4) | Other | Control (ClarityIQ) |
Primary outcome
Patient radiation dose and procedural performance (ClarityIQ vs Xres5)
Time frame: during study procedure
- Cumulative Dose Area Product (DAP) [Gycm2] Total patient group - All procedure types
Patient radiation dose and procedural performance (ClarityIQ vs Xres5)
Time frame: during study procedure
- Cumulative Air Kerma (AK) [Gy] Total patient group - All procedure types
Patient radiation dose and procedural performance (ClarityIQ vs Xres5)
Time frame: during study procedure
- Time System in Use* [minutes] Total patient group - All procedure types
16 secondary outcomes
Patient radiation dose and procedural performance - High BMI (ClarityIQ vs Xres5)
Time frame: During study procedure
Patient radiation dose and procedural performance - High BMI (ClarityIQ vs Xres5)
Time frame: During study procedure
Patient radiation dose and procedural performance - High BMI (ClarityIQ vs Xres5)
Time frame: During study procedure
Patient radiation dose and procedural performance in diagnostic procedures (ClarityIQ vs Xres5)
Time frame: During study procedure
Patient radiation dose and procedural performance in diagnostic procedures (ClarityIQ vs Xres5)
Time frame: During study procedure
Patient radiation dose and procedural performance in diagnostic procedures (ClarityIQ vs Xres5)
Time frame: During study procedure
Patient radiation dose and procedural performance in interventional procedures (ClarityIQ vs Xres5)
Time frame: During study procedure
Patient radiation dose and procedural performance in interventional procedures (ClarityIQ vs Xres5)
Time frame: During study procedure
Patient radiation dose and procedural performance in interventional procedures (ClarityIQ vs Xres5)
Time frame: During study procedure
Coronary Cine Radiation Dose and procedural performance (ClarityIQ vs Xres5)
Time frame: During study procedure
Coronary Cine Radiation Dose and procedural performance (ClarityIQ vs Xres5)
Time frame: During study procedure
Coronary Cine Radiation Dose and procedural performance (ClarityIQ vs Xres5)
Time frame: During study procedure
Coronary Cine Radiation Dose and procedural performance - High BMI (ClarityIQ vs Xres5)
Time frame: During study procedure
Coronary Cine Radiation Dose and procedural performance - High BMI (ClarityIQ vs Xres5)
Time frame: During study procedure
Coronary Cine Radiation Dose and procedural performance - High BMI (ClarityIQ vs Xres5)
Time frame: During study procedure
Ultra-low dose cine fluoro rate (Xres5)
Time frame: During study procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- BackgroundPhilips Medical Systems Nederland B.V., "Safety and feasibility study with a new X-ray processing algorithm (Xres5) for coronary procedures"
- Background: PubMed 27610932Gislason-Lee AJ, Keeble C, Malkin CJ, Egleston D, Bexon J, Kengyelics SM, Blackman D, Davies AG. Impact of latest generation cardiac interventional X-ray equipment on patient image quality and radiation dose for trans-catheter aortic valve implantations. Br J Radiol. 2016 Nov;89(1067):20160269. doi: 10.1259/bjr.20160269. Epub 2016 Sep 29.
- Background: PubMed 25840815Nakamura S, Kobayashi T, Funatsu A, Okada T, Mauti M, Waizumi Y, Yamada S. Patient radiation dose reduction using an X-ray imaging noise reduction technology for cardiac angiography and intervention. Heart Vessels. 2016 May;31(5):655-63. doi: 10.1007/s00380-015-0667-z. Epub 2015 Apr 4.
- Background: PubMed 25471927Hruby A, Hu FB. The Epidemiology of Obesity: A Big Picture. Pharmacoeconomics. 2015 Jul;33(7):673-89. doi: 10.1007/s40273-014-0243-x.
- Background: PubMed 18242136Smith IR, Rivers JT. Measures of radiation exposure in cardiac imaging and the impact of case complexity. Heart Lung Circ. 2008 Jun;17(3):224-31. doi: 10.1016/j.hlc.2007.10.004. Epub 2008 Jan 31.
- Background: PubMed 9973023Cusma JT, Bell MR, Wondrow MA, Taubel JP, Holmes DR Jr. Real-time measurement of radiation exposure to patients during diagnostic coronary angiography and percutaneous interventional procedures. J Am Coll Cardiol. 1999 Feb;33(2):427-35. doi: 10.1016/s0735-1097(98)00591-9.
- Background: PubMed 21435613Fetterly KA, Lennon RJ, Bell MR, Holmes DR Jr, Rihal CS. Clinical determinants of radiation dose in percutaneous coronary interventional procedures: influence of patient size, procedure complexity, and performing physician. JACC Cardiovasc Interv. 2011 Mar;4(3):336-43. doi: 10.1016/j.jcin.2010.10.014.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing treatment with the Azurion system with Xres5 and Azurion with Clairy IQ in people with Coronary Artery Disease, run by Philips Clinical & Medical Affairs Global at 6 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States, Czechia, Denmark, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient radiation dose and procedural performance (ClarityIQ vs Xres5) (time frame: during study procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06944509, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026; AzTrials last refreshed its copy on 31 Oct 2026.