HyperoxemiaHYPER-MINDNCT07377162
HYPER MIND - Hyperoxia Effects on Cerebral Hemodynamics
A study testing Normobaric Hyperoxic Stimulus (NBHO) in people with Hyperoxemia and Cerebrovascular Circulation, run by Erasme University Hospital at 1 site in Belgium.
Trial summary
This study aims to better understand how short periods of exposure to high oxygen levels affect blood flow in the brain of patients who are intubated and mechanically ventilated in the Intensive Care Unit (ICU). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperoxemia, Cerebrovascular Circulation, Cerebral Autoregulation
- What is being tested?
- Normobaric Hyperoxic Stimulus (NBHO)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jan 2024to 31 Dec 2028
- 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
- Adult patients aged ≥18 years
- Admitted to the intensive care unit (ICU)
- Intubated and mechanically ventilated for ≤72 hours
- Receiving volume-controlled mechanical ventilation
- Arterial partial pressure of carbon dioxide (PaCO₂) between 35 and 45 mmHg
- Invasive arterial blood pressure monitoring in place
Show all 9Show fewer
- Adequate transcranial Doppler (TCD) acoustic window
- Clinically judged to be suitable for a brief normobaric hyperoxic stimulus
- Expected to receive one or two hyperoxic steps based on baseline FiO₂ requirements: a) Baseline FiO₂ < 0.5: two-step hyperoxic stimulus (FiO₂ 0.5 followed by FiO₂ 1.0); b) Baseline FiO₂ ≥ 0.5: one-step hyperoxic stimulus (FiO₂ 1.0)
Who cannot join
- Age <18 years
- Pregnancy
- Extracorporeal membrane oxygenation (ECMO)
- Continuous renal replacement therapy (CRRT)
- Contraindications to hyperoxia, as judged by the treating physician
- Severe hemodynamic instability requiring changes in vasopressor dose during the recording period
- Inability to obtain a reliable transcranial Doppler signal through the temporal acoustic windows
- Any clinical condition deemed by the treating physician to pose unacceptable risk during hyperoxic exposure
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Erasme Hospital - ULB
Brussels
Michele Salvagno, MD, +32471386614, michele.salvagno1@gmail.com
About this study
Official title: HYPERMIND - Hyperoxia Effects on Cerebral Hemodynamics
This study aims to better understand how short periods of exposure to high oxygen levels affect blood flow in the brain of patients who are intubated and mechanically ventilated in the Intensive Care Unit (ICU). Many ICU patients receive more oxygen than strictly necessary, and high blood oxygen levels (hyperoxemia) are very common. However, the immediate effects of short hyperoxic exposures on cerebral circulation and autoregulation remain poorly understood.
In this study, patients who already require mechanical ventilation for medical reasons will undergo a brief and controlled increase in the oxygen delivered through the ventilator (FiO₂). During this time, we will continuously monitor blood flow in one of the main brain arteries using a non-invasive ultrasound technique called transcranial Doppler (TCD). The goal is to evaluate how cerebral blood flow, pulsatility, and autoregulatory capacity change during and after a short hyperoxic stimulus.
No additional invasive procedures are required beyond standard ICU monitoring, except for the temporary adjustment of the ventilator's oxygen settings and arterial blood gas sampling, which are part of usual care in critically ill patients. Participation does not provide direct clinical benefit but may help improve future oxygen management in ICU patients. The study involves minimal risk, as short hyperoxic exposures are already common in routine care and will be interrupted immediately in case of any adverse event.
Read the detailed description
Patients will be studied under controlled mechanical ventilation with stable ventilatory, hemodynamic, and sedative settings. Continuous transcranial Doppler (TCD) monitoring will be performed using a 2-MHz probe insonating the middle cerebral artery through the temporal bone window. Cerebral blood flow velocity signals and arterial blood pressure waveforms will be recorded continuously for offline analysis.
The experimental protocol consists of stepwise increases in the fraction of inspired oxygen (FiO₂), according to baseline oxygen requirements. Patients with a baseline FiO₂ < 0.5 will undergo two consecutive hyperoxic steps (FiO₂ 0.5 followed by FiO₂ 1.0), whereas patients with a baseline FiO₂ ≥ 0.5 will undergo a single hyperoxic step (FiO₂ 1.0). Each hyperoxic step will include a stabilization period of approximately 5 minutes to allow attainment of a physiological steady state, followed by a 10-minute recording period dedicated to cerebral hemodynamic and autoregulation assessment. After completion of the hyperoxic exposure(s), FiO₂ will be returned to baseline values. In total, there will be 3 or 4 steps, depending on the baseline FiO₂.
Arterial blood gas samples will be obtained at baseline, at the end of each hyperoxic step, and after return to baseline oxygen settings to document changes in arterial oxygen and carbon dioxide tensions. Ventilation parameters, sedation, vasoactive drug infusion rates, and fluid therapy will be kept constant throughout the protocol whenever clinically feasible.
Cerebral hemodynamic assessment will include mean flow velocity, pulsatility index, and resistive index derived from TCD signals. Dynamic cerebral autoregulation will be evaluated using established indices (the mean flow index (Mxa), transfer function analysis (TFA) parameters, autoregulation index (ARI)), and metrics derived from spontaneous fluctuations in arterial blood pressure and cerebral blood flow velocity.
Analyses will primarily rely on paired statistical methods. Exploratory subgroup analyses according to baseline oxygen requirements, illness severity, or relevant comorbidities may be conducted.
Patient safety will be continuously monitored throughout the protocol, and the procedure will be immediately discontinued in case of any clinical instability, including hemodynamic deterioration, arrhythmias, or oxygenation abnormalities.
- Conditions
- Hyperoxemia, Cerebrovascular Circulation, Cerebral Autoregulation, Critical Illness, Mechanical Ventilation
- Being tested
- Normobaric Hyperoxic Stimulus (NBHO)
- Keywords
- hyperoxemia, brain hemodynamics, tcd, cerebral autoregulation, Critical Illness, intensive care unit, hyperoxia, oxygen
- Medical subject headings
- Critical Illness, Choroideremia, Hyperoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normobaric Hyperoxic Stimulus (NBHO)Other
The intervention consists of a short, controlled increase in the inspired oxygen fraction (FiO₂) delivered by the mechanical ventilator. Depending on baseline FiO₂, patients will receive: Depending on baseline FiO₂, patients will receive:
Two-step NBHO (baseline FiO₂ < 0.5): FiO₂ raised to 0.5 and then to 1.0 One-step NBHO (baseline FiO₂ ≥ 0.5): FiO₂ raised to 1.0 Each step includes 5 minutes to reach steady state followed by a 10-minute recording period. Cerebral blood flow velocity and autoregulation are continuously assessed using transcranial Doppler ultrasound.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Hyperoxic Stimulus | Experimental | Participants receive one or two brief normobaric hyperoxic (NBHO) stimuli during mechanical ventilation. The inspired fraction of oxygen (FiO₂) is transiently increased to 0.5 or 1.0 depending on baseline FiO₂ requirements. Cerebral blood flow and autoregulation are continuously monitored using transcranial Doppler ultrasound. Receives: Other: Normobaric Hyperoxic Stimulus (NBHO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mean Flow Index (Mx) During Normobaric Hyperoxia
Dynamic cerebral autoregulation will be assessed using the mean flow index (Mx), calculated as the moving Pearson correlation coefficient between mean arterial pressure (MAP) and mean middle cerebral artery (MCA) blood flow velocity measured by transcranial Doppler ultrasonography.
The outcome will be reported as the absolute change in Mx from baseline, calculated as the average Mx value during normobaric hyperoxia minus the baseline average.
Measured: Baseline (prior to hyperoxic exposure), during normobaric hyperoxia steps, assessed during the intervention period, and after returning to baseline (assessed up to 20 minutes)
Secondary outcomes (4)
Change in Middle Cerebral Artery Cerebral Blood Flow During Normobaric Hyperoxia
Cerebral hemodynamics will be assessed by transcranial Doppler ultrasonography of the middle cerebral artery (MCA). The cerebral blood flow velocity (cm/s) will be evaluated and analyzed as a change from baseline during normobaric hyperoxia. It will be expressed as the absolute change from baseline, calculated as the average value during the last 5 minutes of normobaric hyperoxia minus the baseline average.
Measured: Baseline (prior to hyperoxic exposure), during normobaric hyperoxia, assessed during the intervention period (up to 30 minutes per study session), and after returning to baseline (assessed up to 20 minutes)
Change in Autoregulation Index (ARI) During Normobaric Hyperoxia
Cerebral autoregulation will also be evaluated using the Autoregulation Index (ARI) derived from transfer function-based step response analysis, expressed on a scale from 0 to 9. The outcome will be expressed as the absolute change from baseline during normobaric hyperoxia.
Measured: Baseline (prior to hyperoxic exposure), during normobaric hyperoxia, assessed during the intervention period (up to 30 minutes per study session), and after returning to baseline (assessed up to 20 minutes)
Change in Transfer Function Analysis Parameters During Normobaric Hyperoxia
Transfer function analysis (TFA) between mean arterial pressure and middle cerebral artery blood flow velocity will be performed. Gain (cm/s/mmHg) will be analyzed in the low-frequency band (0.07-0.20 Hz). It will be expressed as absolute change from baseline during normobaric hyperoxia.
Measured: Baseline (prior to hyperoxic exposure), during normobaric hyperoxia, assessed during the intervention period (up to 30 minutes per study session), and after returning to baseline (assessed up to 20 minutes)
Change in Transfer Function Analysis Parameters During Normobaric Hyperoxia
Description: Transfer function analysis (TFA) between mean arterial pressure and middle cerebral artery blood flow velocity will be performed. Phase (radians) will be analyzed in the low-frequency band (0.07-0.20 Hz). It will be expressed as absolute change from baseline during normobaric hyperoxia.
Measured: Baseline (prior to hyperoxic exposure), during normobaric hyperoxia, assessed during the intervention period (up to 30 minutes per study session), and after returning to baseline (assessed up to 20 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start1 Jan 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperoxemiaStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Participants will undergo one or two controlled hyperoxic stimuli depending on baseline FiO₂. All participants receive the same physiological intervention consisting of a brief increase in inspired oxygen fraction (FiO₂), with cerebral hemodynamics monitored using continuous transcranial Doppler. No randomization is performed.
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasme University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fabio Taccone, Erasme University Hospital
- Investigators
- Fabio Silvio Taccone, MD, PhD, Principal investigator, Hôpital Erasme - Université Libre de Bruxelles (ULB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07377162
- Sponsor's protocol ID
- SRB2023205
- Acronym
- HYPER-MIND
- Status last verified
- Jan 2026
- First submitted
- 11 Dec 2025
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because the data are collected within Hôpital Erasme - ULB and contain coded clinical information that cannot be transferred outside the institution according to local ethical and data protection policies. Only aggregated, non-identifiable results will be shared through scientific publications or presentations.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HYPERMIND - Hyperoxia Effects on Cerebral Hemodynamics
- ClinicalTrials.gov ID
- NCT07377162
- Acronym / sponsor ID
- HYPER-MIND / SRB2023205
- Conditions
- Hyperoxemia, Cerebrovascular Circulation, Cerebral Autoregulation, Critical Illness, Mechanical Ventilation
- Keywords
- hyperoxemia, brain hemodynamics, tcd, cerebral autoregulation, Critical Illness, intensive care unit, hyperoxia, oxygen
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Erasme University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 29 Jan 2026 (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.
This study aims to better understand how short periods of exposure to high oxygen levels affect blood flow in the brain of patients who are intubated and mechanically ventilated in the Intensive Care Unit (ICU). Many ICU patients receive more oxygen than strictly necessary, and high blood oxygen levels (hyperoxemia) are very common. However, the immediate effects of short hyperoxic exposures on cerebral circulation and autoregulation remain poorly understood.
In this study, patients who already require mechanical ventilation for medical reasons will undergo a brief and controlled increase in the oxygen delivered through the ventilator (FiO₂). During this time, we will continuously monitor blood flow in one of the main brain arteries using a non-invasive ultrasound technique called transcranial Doppler (TCD). The goal is to evaluate how cerebral blood flow, pulsatility, and autoregulatory capacity change during and after a short hyperoxic stimulus.
No additional invasive procedures are required beyond standard ICU monitoring, except for the temporary adjustment of the ventilator's oxygen settings and arterial blood gas sampling, which are part of usual care in critically ill patients. Participation does not provide direct clinical benefit but may help improve future oxygen management in ICU patients. The study involves minimal risk, as short hyperoxic exposures are already common in routine care and will be interrupted immediately in case of any adverse event.
Detailed description
Patients will be studied under controlled mechanical ventilation with stable ventilatory, hemodynamic, and sedative settings. Continuous transcranial Doppler (TCD) monitoring will be performed using a 2-MHz probe insonating the middle cerebral artery through the temporal bone window. Cerebral blood flow velocity signals and arterial blood pressure waveforms will be recorded continuously for offline analysis.
The experimental protocol consists of stepwise increases in the fraction of inspired oxygen (FiO₂), according to baseline oxygen requirements. Patients with a baseline FiO₂ < 0.5 will undergo two consecutive hyperoxic steps (FiO₂ 0.5 followed by FiO₂ 1.0), whereas patients with a baseline FiO₂ ≥ 0.5 will undergo a single hyperoxic step (FiO₂ 1.0). Each hyperoxic step will include a stabilization period of approximately 5 minutes to allow attainment of a physiological steady state, followed by a 10-minute recording period dedicated to cerebral hemodynamic and autoregulation assessment. After completion of the hyperoxic exposure(s), FiO₂ will be returned to baseline values. In total, there will be 3 or 4 steps, depending on the baseline FiO₂.
Arterial blood gas samples will be obtained at baseline, at the end of each hyperoxic step, and after return to baseline oxygen settings to document changes in arterial oxygen and carbon dioxide tensions. Ventilation parameters, sedation, vasoactive drug infusion rates, and fluid therapy will be kept constant throughout the protocol whenever clinically feasible.
Cerebral hemodynamic assessment will include mean flow velocity, pulsatility index, and resistive index derived from TCD signals. Dynamic cerebral autoregulation will be evaluated using established indices (the mean flow index (Mxa), transfer function analysis (TFA) parameters, autoregulation index (ARI)), and metrics derived from spontaneous fluctuations in arterial blood pressure and cerebral blood flow velocity.
Analyses will primarily rely on paired statistical methods. Exploratory subgroup analyses according to baseline oxygen requirements, illness severity, or relevant comorbidities may be conducted.
Patient safety will be continuously monitored throughout the protocol, and the procedure will be immediately discontinued in case of any clinical instability, including hemodynamic deterioration, arrhythmias, or oxygenation abnormalities.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants will undergo one or two controlled hyperoxic stimuli depending on baseline FiO₂. All participants receive the same physiological intervention consisting of a brief increase in inspired oxygen fraction (FiO₂), with cerebral hemodynamics monitored using continuous transcranial Doppler. No randomization is performed.
| Arm | Type | Receives |
|---|---|---|
| Experimental: Hyperoxic Stimulus | Experimental | Other: Normobaric Hyperoxic Stimulus (NBHO)Participants receive one or two brief normobaric hyperoxic (NBHO) stimuli during mechanical ventilation. The inspired fraction of oxygen (FiO₂) is transiently increased to 0.5 or 1.0 depending on baseline FiO₂ requirements. Cerebral blood flow and autoregulation are continuously monitored using transcranial Doppler ultrasound. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adult patients aged ≥18 years
- Admitted to the intensive care unit (ICU)
- Intubated and mechanically ventilated for ≤72 hours
- Receiving volume-controlled mechanical ventilation
- Arterial partial pressure of carbon dioxide (PaCO₂) between 35 and 45 mmHg
Key exclusion criteria (8 listed)
- Age <18 years
- Pregnancy
- Extracorporeal membrane oxygenation (ECMO)
- Continuous renal replacement therapy (CRRT)
- Contraindications to hyperoxia, as judged by the treating physician
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 |
|---|---|---|
| Normobaric Hyperoxic Stimulus (NBHO)The intervention consists of a short, controlled increase in the inspired oxygen fraction (FiO₂) delivered by the mechanical ventilator. Depending on baseline FiO₂, patients will receive: Depending on baseline FiO₂, patients will receive: Two-step NBHO (baseline FiO₂ < 0.5): FiO₂ raised to 0.5 and then to 1.0 One-step NBHO (baseline FiO₂ ≥ 0.5): FiO₂ raised to 1.0 Each step includes 5 minutes to reach steady state followed by a 10-minute recording period. Cerebral blood flow velocity and autoregulation are continuously assessed using transcranial Doppler ultrasound. | Other | Experimental: Hyperoxic Stimulus |
Primary outcome
Change in Mean Flow Index (Mx) During Normobaric Hyperoxia
Time frame: Baseline (prior to hyperoxic exposure), during normobaric hyperoxia steps, assessed during the intervention period, and after returning to baseline (assessed up to 20 minutes)
Dynamic cerebral autoregulation will be assessed using the mean flow index (Mx), calculated as the moving Pearson correlation coefficient between mean arterial pressure (MAP) and mean middle cerebral artery (MCA) blood flow velocity measured by transcranial Doppler ultrasonography. The outcome will be reported as the absolute change in Mx from baseline, calculated as the average Mx value during normobaric hyperoxia minus the baseline average.
4 secondary outcomes
Change in Middle Cerebral Artery Cerebral Blood Flow During Normobaric Hyperoxia
Time frame: Baseline (prior to hyperoxic exposure), during normobaric hyperoxia, assessed during the intervention period (up to 30 minutes per study session), and after returning to baseline (assessed up to 20 minutes)
Change in Autoregulation Index (ARI) During Normobaric Hyperoxia
Time frame: Baseline (prior to hyperoxic exposure), during normobaric hyperoxia, assessed during the intervention period (up to 30 minutes per study session), and after returning to baseline (assessed up to 20 minutes)
Change in Transfer Function Analysis Parameters During Normobaric Hyperoxia
Time frame: Baseline (prior to hyperoxic exposure), during normobaric hyperoxia, assessed during the intervention period (up to 30 minutes per study session), and after returning to baseline (assessed up to 20 minutes)
Change in Transfer Function Analysis Parameters During Normobaric Hyperoxia
Time frame: Baseline (prior to hyperoxic exposure), during normobaric hyperoxia, assessed during the intervention period (up to 30 minutes per study session), and after returning to baseline (assessed up to 20 minutes)
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 29 Jan 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because the data are collected within Hôpital Erasme - ULB and contain coded clinical information that cannot be transferred outside the institution according to local ethical and data protection policies. Only aggregated, non-identifiable results will be shared through scientific publications or presentations.
Related trials for Hyperoxemia
Not yet recruitingObservational study
Hyperoxemia and Oxygen Reserve Index During Neurointerventional Anesthesia
Hyperoxia, Hyperoxemia
Not yet recruiting
ORI-Guided Oxygen Therapy During One-Lung Ventilation
Thoracic Surgery With One-lung Ventilation
Not yet recruiting
Oxygen Reserve Index-Guided Oxygen Titration During Surgery in the Beach Chair Position
Hyperoxemia, Intraoperative Oxygen Therapy
RecruitingObservational study
Comparison of Pulse Oximetry (SpO2) With Different Oximeters and Arterial Saturation (SaO2): Oxygap2 Study
Respiratory Failure, Hypoxemia
Active, not recruitingPhase 3
Strategy to Avoid Excessive Oxygen in Major Burn Patients
Critical Illness, Wounds and Injury
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.
Fabio Silvio Taccone, MD, PhD principal investigator
Hôpital Erasme - Université Libre de Bruxelles (ULB)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Normobaric Hyperoxic Stimulus (NBHO) in people with Hyperoxemia and Cerebrovascular Circulation, run by Erasme University Hospital at 1 site in Belgium.
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 9 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 29 Jan 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 Belgium. 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?
Contact Michele Salvagno, MD (+32471386614, michele.salvagno@ulb.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Mean Flow Index (Mx) During Normobaric Hyperoxia (time frame: Baseline (prior to hyperoxic exposure), during normobaric hyperoxia steps, assessed during the intervention period, and after returning to baseline (assessed up to 20 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jan 2026.