Clinical Decision Support SystemICUCockpiAppNCT04748289
ICU Cockpit Apps: Interventional Study With First ICU Cockpit Software Applications
A study testing ICU Cockpit software testing in people with Clinical Decision Support System, run by Emanuela Keller at 1 site in Switzerland.
Trial summary
In neurocritical care, besides the standard intensive care monitoring, even more data are obtained from the very complex pathophysiological changes in brain disease. Medical staff for decision-making cannot integrate the huge amount of clinical data generated every second and visualized on different monitors, anymore. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Clinical Decision Support System
- What is being tested?
- ICU Cockpit software testing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Mar 2021to 9 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients admitted to the Neurointensive Care Unit (NICU)
- Informed Consent by signature from representative / patient
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich
Zurich, Canton of Zurich, CH-8091
About this study
Official title: Integrated Platform for Multimodal Patient Monitoring and Therapy Support in ICU Patients: Interventional Study With First ICU Cockpit Software Applications
In neurocritical care, besides the standard intensive care monitoring, even more data are obtained from the very complex pathophysiological changes in brain disease. Medical staff for decision-making cannot integrate the huge amount of clinical data generated every second and visualized on different monitors, anymore. Lack of data integration and usability is a major reason that only few of the knowledge physicians use in this field is evidence based.
Early warning systems, powered by predictive algorithms that detect critical states before they happen would allow the staff to intervene early and mitigate or even prevent such a critical state.
Read the detailed description
Background:
Since 2014, the project "ICU-Cockpit" has been set up at the Neurointensive Unit of the University Hospital Zurich in collaboration with the University of Zurich and ETH Zurich. State-of-the-art information technology collects, synchronizes and encrypts data from numerous medical devices in real time. The project is aimed at initiating a fundamental development in emergency and intensive medicine - and bringing about a substantial improvement in the way diagnostics, treatment and risk management are handled in everyday clinical practice.
Based on video monitoring, algorithms for early alarm systems and therapy support have been already developed. In order to make the algorithms usable for clinical practice, a user interface (GUI) is currently being developed in cooperation with the University of Applied Sciences Northwestern Switzerland (FHNW), see appendix 15. The GUI allows to visualize and interpret the multimodal patient data in a comprehensive manner.
In 2016, a research project started at the NICU of the University Hospital Zurich started with the title "ICU Cockpit: Integrated platform for multimodal patient monitoring and therapy support in neurocritical care" (BASEC No. 2016-01101). The purpose of the single site project is to set up an integrated platform (scientific prototype of ICU Cockpit software platform) for multimodal patient monitoring and therapy support in neurocritical care, and as a second step to develop and validate algorithms for some first clinical applications. Furthermore, automatic artefacts detections (i.e., number of false and true alarms in ICU Cockpit in comparison to standard monitoring system) are assessed and algorithms are developed for the early detection of epileptic seizures and secondary impairment of cerebral perfusion.
The objective of this current clinical investigation is the verification and validation of the ICU Cockpit software platform and the following three different applications for prognostication and prediction of complications:
- ICU Cockpit COVID-19 for remote monitoring of isolated patients, b) ICU Cockpit Stable State for a comprehensive visualization of vital parameters and as additional aid in early detection of imminent critical complications c) ICU Cockpit Cerebral Ischemia for the prediction of delayed cerebral ischemia in patients with subarachnoid hemorrhage (SAH).
- ICU Cockpit COVID-19 for remote monitoring of isolated patients Having infected more than 100 000 people in 100 countries, the coronavirus disease 2019 (COVID-19) has become a pandemic. In China, up to 10% of patients with COVID-19 became severely ill requiring intensive care treatment mostly due to pneumonia, acute respiratory distress syndrome (ARDS) and multiorgan failure. In Italy, having about 5200 beds in intensive care units (ICUs), already 1028 were already devoted to patients with COVID-19 by March 11. Furthermore, 20% of health-care professionals, at this time, have become already infected, and some have died. For the United States, without self-isolation and for R0 = 2 and R0 = 2.5, respectively, ICU admissions are projected to become 17.4 to 25.7 per 1,000 population, which would significantly exceed the capacity of the existing 100,000 ICU beds in the US. Also, in Switzerland the health care system and especially ICUs are facing extraordinary challenges as human resources for ICU professionals are limited. Advances in medical informatics have the potential to facilitate medical care and save personnel resources not only in the ambulatory sector but in the ICUs especially during epidemics. In intensive and emergency medicine, the situation is compounded by real-time signals from multiple sensors on, as well as inside the human body. In an emergency situation, in particular, it is not possible to integrate this flood of information rapidly into the decision-making process. Remote monitoring of strictly isolated patients especially reduces routes and walking of the staff, the number of close contacts with infected patients and therefore, virus transmission. The safety of patients will be increased by a reduction of stress and burnouts in nurses and medical doctors, which often work in crisis over time.
- ICU Cockpit Stable State As a first application a software called "stable state" has been developed recently. Vital parameters as arterial blood pressure, intracranial pressure and many others are hard to read in a glance due to their high information density. Since the human body is a complexly inter-connected system, these biosignals are also heavily correlated. Experienced clinicians can recognize deviations in the correlational structure of several signals, but it is impossible to grasp the full picture for the huge amount of available data. However, subtle correlational changes may indicate an instable state of a patient before these changes are visible in a specific signal or its compound measure. An algorithm which computes the inter-dependencies in an arbitrary set of signals during a stable phase of the patient was recently developed. This stable state is compared to an on-line estimate of the current state. Correlational changes are didactically reduced and visualized in a Mondrian-like display for quick comparisons of current and past states. The application "stable state" as part of the GUI ICU Cockpit is planned to be implemented as an additional aid in early detection of imminent critical complications.
- ICU Cockpit Cerebral Ischemia Cerebral vasospasm (CVS) is a delayed morphologic narrowing of cerebral arteries, occurring 4 to 10 days after aneurysmal subarachnoid hemorrhage. Classically, CVS has been associated with delayed cerebral ischemia (DCI), which ultimately leads to cerebral infarction associated with morbidity and mortality. This has been sort of a paradigm, and the term CVS has been often misused to describe clinical signs of DCI. The majority of research was focused on the assumption CVS to be solely responsible for DCI. Today, it is well accepted that not all patients with CVS develop DCI. Inversely, DCI can occur in the absence of CVS. Recent review of the literature indicates that CVS is not the only cause of DCI and that the entire picture of DCI is multifactorial. There is an ongoing debate about this issue, however cerebral infarction on imaging studies might be the most appropriate measure of DCI beside functional outcome. Therefore, an algorithm to predict DCI based on a random forest model has been developed, which allows to identify biomarkers for the occurrence 24h to 48 hours before.
- Conditions
- Clinical Decision Support System
- Being tested
- ICU Cockpit software testing
- Keywords
- Secondary brain injuries, COVID-19, Subarachnoid hemorrhage
- Medical subject headings
- COVID-19, Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICU Cockpit software testingDevice
the ICU Cockpit Software Platform is intended to be used for monitoring of patient characteristics and vital physiological parameters in patients at the Neurointensive Care Unit of the University Hospital Zurich.
Furthermore, three different applications for prognostication and prediction of complications will be tested:
- ICU Cockpit COVID-19 for remote monitoring of isolated patients,
- ICU Cockpit Stable State for a comprehensive visualization of vital parameters and as additional aid in early detection of imminent critical complications
- ICU Cockpit Cerebral Ischemia for the prediction of delayed DCI in patients with subarachnoid hemorrhage (SAH).
| Study group | Role | What they receive |
|---|---|---|
| NICU patients | Experimental | All patients admitted to the Neurointensive Care Unit (NICU) Receives: Device: ICU Cockpit software testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Verification of ICU Cockpit software for remote monitoring of isolated patients
Repeatability, reliability, performance of prediction of models results will be testet against ground truth (annotations by experts).
Measured: 2 years
Verification of ICU Cockpit software ICU Cockpit Stable State
Repeatability, reliability, performance of prediction of models results will be testet against ground truth (annotations by experts).
Measured: 2 years
Verification of ICU Cockpit software Cerebral Ischemia
Prediction score estimated by the app ICU Cockpit Cerebral Ischemia compared to probability estimation by medical experts in surveys.
Measured: 2 years
Adverse events, complaints and use-errors reporting
Reporting of adverse events (incl. device deficiencies), complaints as well as use-errors.
Measured: 2 years
Usability testing
Usability testing by distributing the Software Usability Questionnaire to involved medical staff (n=65).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2021
- Study start1 Mar 2021
- Primary completion9 Apr 2026
- Study completion9 Apr 2026
Why it stopped: new follow-up study will start in 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Clinical Decision Support SystemStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open labelled, single centre clinical investigation, with the new ICU Cockpit Software Platform (medical device).
- Masking
- None (open label)
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emanuela Keller
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Emanuela Keller, University of Zurich
- Investigators
- Emanuela Keller, MD, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04748289
- Sponsor's protocol ID
- 2020-02177
- Acronym
- ICUCockpiApp
- Status last verified
- Apr 2026
- First submitted
- 27 Jan 2021
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Callaway E, Cyranoski D, Mallapaty S, Stoye E, Tollefson J. The coronavirus pandemic in five powerful charts. Nature. 2020 Mar;579(7800):482-483. doi: 10.1038/d41586-020-00758-2. No abstract available.
PubMed 32203366Yang X, Yu Y, Xu J, Shu H, Xia J, Liu H, Wu Y, Zhang L, Yu Z, Fang M, Yu T, Wang Y, Pan S, Zou X, Yuan S, Shang Y. Clinical course and outcomes of critically ill patients with SARS-CoV-2 pneumonia in Wuhan, China: a single-centered, retrospective, observational study. Lancet Respir Med. 2020 May;8(5):475-481. doi: 10.1016/S2213-2600(20)30079-5. Epub 2020 Feb 24.
PubMed 32105632Hollander JE, Carr BG. Virtually Perfect? Telemedicine for Covid-19. N Engl J Med. 2020 Apr 30;382(18):1679-1681. doi: 10.1056/NEJMp2003539. Epub 2020 Mar 11. No abstract available.
PubMed 32160451Vergouwen MD, Ilodigwe D, Macdonald RL. Cerebral infarction after subarachnoid hemorrhage contributes to poor outcome by vasospasm-dependent and -independent effects. Stroke. 2011 Apr;42(4):924-9. doi: 10.1161/STROKEAHA.110.597914. Epub 2011 Feb 10.
PubMed 21311062
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Platform for Multimodal Patient Monitoring and Therapy Support in ICU Patients: Interventional Study With First ICU Cockpit Software Applications
- ClinicalTrials.gov ID
- NCT04748289
- Acronym / sponsor ID
- ICUCockpiApp / 2020-02177
- Conditions
- Clinical Decision Support System
- Keywords
- Secondary brain injuries, COVID-19, Subarachnoid hemorrhage
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: new follow-up study will start in 2026
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Emanuela KellerUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 9 Apr 2026 (actual)
- Study completion
- 9 Apr 2026 (actual)
- First posted
- 10 Feb 2021 (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.
In neurocritical care, besides the standard intensive care monitoring, even more data are obtained from the very complex pathophysiological changes in brain disease. Medical staff for decision-making cannot integrate the huge amount of clinical data generated every second and visualized on different monitors, anymore. Lack of data integration and usability is a major reason that only few of the knowledge physicians use in this field is evidence based.
Early warning systems, powered by predictive algorithms that detect critical states before they happen would allow the staff to intervene early and mitigate or even prevent such a critical state.
Detailed description
Background:
Since 2014, the project "ICU-Cockpit" has been set up at the Neurointensive Unit of the University Hospital Zurich in collaboration with the University of Zurich and ETH Zurich. State-of-the-art information technology collects, synchronizes and encrypts data from numerous medical devices in real time. The project is aimed at initiating a fundamental development in emergency and intensive medicine - and bringing about a substantial improvement in the way diagnostics, treatment and risk management are handled in everyday clinical practice.
Based on video monitoring, algorithms for early alarm systems and therapy support have been already developed. In order to make the algorithms usable for clinical practice, a user interface (GUI) is currently being developed in cooperation with the University of Applied Sciences Northwestern Switzerland (FHNW), see appendix 15. The GUI allows to visualize and interpret the multimodal patient data in a comprehensive manner.
In 2016, a research project started at the NICU of the University Hospital Zurich started with the title "ICU Cockpit: Integrated platform for multimodal patient monitoring and therapy support in neurocritical care" (BASEC No. 2016-01101). The purpose of the single site project is to set up an integrated platform (scientific prototype of ICU Cockpit software platform) for multimodal patient monitoring and therapy support in neurocritical care, and as a second step to develop and validate algorithms for some first clinical applications. Furthermore, automatic artefacts detections (i.e., number of false and true alarms in ICU Cockpit in comparison to standard monitoring system) are assessed and algorithms are developed for the early detection of epileptic seizures and secondary impairment of cerebral perfusion.
The objective of this current clinical investigation is the verification and validation of the ICU Cockpit software platform and the following three different applications for prognostication and prediction of complications:
- ICU Cockpit COVID-19 for remote monitoring of isolated patients, b) ICU Cockpit Stable State for a comprehensive visualization of vital parameters and as additional aid in early detection of imminent critical complications c) ICU Cockpit Cerebral Ischemia for the prediction of delayed cerebral ischemia in patients with subarachnoid hemorrhage (SAH).
- ICU Cockpit COVID-19 for remote monitoring of isolated patients Having infected more than 100 000 people in 100 countries, the coronavirus disease 2019 (COVID-19) has become a pandemic. In China, up to 10% of patients with COVID-19 became severely ill requiring intensive care treatment mostly due to pneumonia, acute respiratory distress syndrome (ARDS) and multiorgan failure. In Italy, having about 5200 beds in intensive care units (ICUs), already 1028 were already devoted to patients with COVID-19 by March 11. Furthermore, 20% of health-care professionals, at this time, have become already infected, and some have died. For the United States, without self-isolation and for R0 = 2 and R0 = 2.5, respectively, ICU admissions are projected to become 17.4 to 25.7 per 1,000 population, which would significantly exceed the capacity of the existing 100,000 ICU beds in the US. Also, in Switzerland the health care system and especially ICUs are facing extraordinary challenges as human resources for ICU professionals are limited. Advances in medical informatics have the potential to facilitate medical care and save personnel resources not only in the ambulatory sector but in the ICUs especially during epidemics. In intensive and emergency medicine, the situation is compounded by real-time signals from multiple sensors on, as well as inside the human body. In an emergency situation, in particular, it is not possible to integrate this flood of information rapidly into the decision-making process. Remote monitoring of strictly isolated patients especially reduces routes and walking of the staff, the number of close contacts with infected patients and therefore, virus transmission. The safety of patients will be increased by a reduction of stress and burnouts in nurses and medical doctors, which often work in crisis over time.
- ICU Cockpit Stable State As a first application a software called "stable state" has been developed recently. Vital parameters as arterial blood pressure, intracranial pressure and many others are hard to read in a glance due to their high information density. Since the human body is a complexly inter-connected system, these biosignals are also heavily correlated. Experienced clinicians can recognize deviations in the correlational structure of several signals, but it is impossible to grasp the full picture for the huge amount of available data. However, subtle correlational changes may indicate an instable state of a patient before these changes are visible in a specific signal or its compound measure. An algorithm which computes the inter-dependencies in an arbitrary set of signals during a stable phase of the patient was recently developed. This stable state is compared to an on-line estimate of the current state. Correlational changes are didactically reduced and visualized in a Mondrian-like display for quick comparisons of current and past states. The application "stable state" as part of the GUI ICU Cockpit is planned to be implemented as an additional aid in early detection of imminent critical complications.
- ICU Cockpit Cerebral Ischemia Cerebral vasospasm (CVS) is a delayed morphologic narrowing of cerebral arteries, occurring 4 to 10 days after aneurysmal subarachnoid hemorrhage. Classically, CVS has been associated with delayed cerebral ischemia (DCI), which ultimately leads to cerebral infarction associated with morbidity and mortality. This has been sort of a paradigm, and the term CVS has been often misused to describe clinical signs of DCI. The majority of research was focused on the assumption CVS to be solely responsible for DCI. Today, it is well accepted that not all patients with CVS develop DCI. Inversely, DCI can occur in the absence of CVS. Recent review of the literature indicates that CVS is not the only cause of DCI and that the entire picture of DCI is multifactorial. There is an ongoing debate about this issue, however cerebral infarction on imaging studies might be the most appropriate measure of DCI beside functional outcome. Therefore, an algorithm to predict DCI based on a random forest model has been developed, which allows to identify biomarkers for the occurrence 24h to 48 hours before.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open labelled, single centre clinical investigation, with the new ICU Cockpit Software Platform (medical device).
| Arm | Type | Receives |
|---|---|---|
| NICU patients | Experimental | Device: ICU Cockpit software testingAll patients admitted to the Neurointensive Care Unit (NICU) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- All patients admitted to the Neurointensive Care Unit (NICU)
- Informed Consent by signature from representative / patient
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| ICU Cockpit software testingthe ICU Cockpit Software Platform is intended to be used for monitoring of patient characteristics and vital physiological parameters in patients at the Neurointensive Care Unit of the University Hospital Zurich. Furthermore, three different applications for prognostication and prediction of complications will be tested: 1. ICU Cockpit COVID-19 for remote monitoring of isolated patients, 2. ICU Cockpit Stable State for a comprehensive visualization of vital parameters and as additional aid in early detection of imminent critical complications 3. ICU Cockpit Cerebral Ischemia for the prediction of delayed DCI in patients with subarachnoid hemorrhage (SAH). | Device | NICU patients |
Primary outcome
Verification of ICU Cockpit software for remote monitoring of isolated patients
Time frame: 2 years
Repeatability, reliability, performance of prediction of models results will be testet against ground truth (annotations by experts).
Verification of ICU Cockpit software ICU Cockpit Stable State
Time frame: 2 years
Repeatability, reliability, performance of prediction of models results will be testet against ground truth (annotations by experts).
Verification of ICU Cockpit software Cerebral Ischemia
Time frame: 2 years
Prediction score estimated by the app ICU Cockpit Cerebral Ischemia compared to probability estimation by medical experts in surveys.
Adverse events, complaints and use-errors reporting
Time frame: 2 years
Reporting of adverse events (incl. device deficiencies), complaints as well as use-errors.
Usability testing
Time frame: 2 years
Usability testing by distributing the Software Usability Questionnaire to involved medical staff (n=65).
Results and safety
The study was stopped early (reason given: new follow-up study will start in 2026). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Background: PubMed 32203366Callaway E, Cyranoski D, Mallapaty S, Stoye E, Tollefson J. The coronavirus pandemic in five powerful charts. Nature. 2020 Mar;579(7800):482-483. doi: 10.1038/d41586-020-00758-2. No abstract available.
- Background: PubMed 32105632Yang X, Yu Y, Xu J, Shu H, Xia J, Liu H, Wu Y, Zhang L, Yu Z, Fang M, Yu T, Wang Y, Pan S, Zou X, Yuan S, Shang Y. Clinical course and outcomes of critically ill patients with SARS-CoV-2 pneumonia in Wuhan, China: a single-centered, retrospective, observational study. Lancet Respir Med. 2020 May;8(5):475-481. doi: 10.1016/S2213-2600(20)30079-5. Epub 2020 Feb 24.
- Background: PubMed 32160451Hollander JE, Carr BG. Virtually Perfect? Telemedicine for Covid-19. N Engl J Med. 2020 Apr 30;382(18):1679-1681. doi: 10.1056/NEJMp2003539. Epub 2020 Mar 11. No abstract available.
- Background: PubMed 21311062Vergouwen MD, Ilodigwe D, Macdonald RL. Cerebral infarction after subarachnoid hemorrhage contributes to poor outcome by vasospasm-dependent and -independent effects. Stroke. 2011 Apr;42(4):924-9. doi: 10.1161/STROKEAHA.110.597914. Epub 2011 Feb 10.
- 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.
Emanuela Keller, MD principal investigator
University of Zurich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICU Cockpit software testing in people with Clinical Decision Support System, run by Emanuela Keller at 1 site in Switzerland.
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 2 inclusion and 1 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: stopped early, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. 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?
The study was stopped early (reason given: new follow-up study will start in 2026). Results are not available in the source record.
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?
Verification of ICU Cockpit software for remote monitoring of isolated patients (time frame: 2 years). The study lists 5 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 NCT04748289, which also lists 4 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 4 May 2026.