Brain Edema Caused by DrugsPhase 4TIVolBrainNCT06779890
Effect of Volatile- Based Versus Total Intravenous Anesthesia on Brain Homeostasis and Neurocognitive Outcome
A Phase 4 study testing Sevoflurane and Desflurane in people with Brain Edema Caused by Drugs and Cerebral Oxygenation, run by Georgia Tsaousi at 2 sites in Greece.
Trial summary
The brain is a metabolic active organ with constant energy demands. Brain oxygen supply is secured via cerebral circulation. Brain tumor surgery is commonly associated with the tumor's underlying pathophysiology including brain swelling or edema. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Brain Edema Caused by Drugs, Cerebral Oxygenation
- What is being tested?
- Sevoflurane and Desflurane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 2 sitesGreece
- Study dates
- 12 May 2025to 30 Sep 2026
- Phase
- Phase 4
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA-PS 1-3 (American Society of Anesthesiologists Physical Status classification)
- Elective or semi-elective craniotomy for brain tumor resection
- Signed informed consent
Who cannot join
- History of craniotomy at the same site
- Morbid obesity
- Delirious person before surgery
- Cognitive disturbances
- Preoperative heart rate (HR) <45 beats/min or second or third degree AV block
- Treatment with a-methyldopa, clonidine or other a2-adrenergic agonist
- Pregnancy
- Liver or renal failure
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Greece2 sites, 2 recruiting
- Recruiting
AHEPA University Hospital
Thessaloniki, 54645
Georgia Tsaousi, Professor, +302310994855, tsaousig@otenet.gr
Eleni Chatsiou, eleni.chatsiou@gmail.com
- Recruiting
Aristotle University of Thessaloniki
Thessaloniki, 56224
Georgia Tsaousi, Professor, +2310994855, tsaousig@otenet.gr
About this study
Official title: Effect of Volatile-based Versus Total Intravenous Anesthesia on Cerebral Homeostasis and Neucognitive Function in Patients Undergoing Elective Craniotomy for Brain Tumor Excision.
The brain is a metabolic active organ with constant energy demands. Brain oxygen supply is secured via cerebral circulation. Brain tumor surgery is commonly associated with the tumor's underlying pathophysiology including brain swelling or edema. During craniotomy for brain tumor resection maintenance of cerebral hemodynamic stability is of paramount importance. Neuroinflammation is also a normal response to trauma, such as in the case of brain tumor surgery. The role of neuroinflammation in postoperative brain function is well documented and the aim is to limit it through an appropriate anesthetic approach.
Anesthetic agents used during surgery affect brain homeostasis. The anesthetic agent of choice for neurosurgery should deliver smooth and hemodynamically stable anesthesia, good operating conditions, and allow early neurological assessment. Also, the ideal anesthetic agent should preserve cerebral perfusion and neuroprotection.
Read more
The two most common categories of anesthetic agents used nowadays for elective craniotomy are intravenous and inhalational agents.
Propofol is the intravenous anesthetic agent of choice. The action of propofol involves a positive modulation of the inhibitory function of the neurotransmitter gamma-aminobutyric acid (GABA). Propofol causes a decrease in cerebral metabolic rate (CMR), intracranial pressure (ICP), cerebral perfusion pressure (CPP), and cerebral blood flow (CBF). It also is known for its antiemetic properties.
Volatile agents commonly used in neuroanesthesia clinical practice are sevoflurane and desflurane. Both of these agents decrease CMR while maintaining stable CPP. CBF alteration is dose-dependent. Desflurane evokes a greater cerebral vasodilation effect than sevoflurane. Sevoflurane is a well-known neuroprotective anesthetic agent traditionally used in neurosurgery. Both desflurane and sevoflurane are associated with early emergence.
Thus, this study aimed to explore the effect of volatile-based versus total intravenous anesthesia on cerebral homeostasis and neurocognitive function in patients undergoing elective craniotomy for brain tumor excision aiming to provide a basis for clinical rational drug use in patients undergoing craniotomy resection of supratentorial lesions.
Read the detailed description
Each participant will receive standard monitoring (ECG, SpO2, SBP, BIS, urine output, temperature). More detailed hemodynamic monitoring will be obtained by the Edwards Lifesciences ClearSight system (CO, CI, SV, SVI, SVV, SVR, SVRI), while the analgesic efficacy of remifentanil will be assessed by Nociception index (NOL) monitoring.
TCI Remifentanil and propofol 2 mg/kg bolus dose will be the agents of choice for induction in anesthesia and cisatracurium will be used for neuromuscular blockade for intubation, while maintenance of anesthesia will be either volatile-based (sevoflurane or desflurane in low flow anesthesia approach) or propofol-based (TCI mode).
Protective mechanical ventilation will be chosen (7ml/kg IBW) with a respiratory rate to obtain a PaCO2 of 35-40 mmHg. PEEP will be changed for the best PaO2/FiO2 ratio and FiO2 of choice will be 0.5.
The radial artery catheterization will be applied for direct blood pressure measurement and arterial blood gas sampling (pH, PaO2, PaCO2, HCO3, BE, osmolality, lactic acid, Hb, glucose, Na and K will be measured).
The jugular bulb ipsilateral to the craniotomy site will be catheterized for receiving blood samples for blood gas analysis. The following oxygenation and metabolic parameters / derivates will be registered or calculated: SjvO2, pH, PjvO2, PjvCO2, HCO3, BE, Osmolality, Lactic acid jv, Hb, Glucose, Na, K, AjvDO2, AjvCO2, O2ERbr, eRQbr, AjvDL, and LOI.
Phases
- T0: after jugular bulb cannulation
- T30: 30 minutes after administration of either sevoflurane, desflurane, or propofol
- T60: 60 minutes after administration of either sevoflurane, desflurane, or propofol
- T120: 120 minutes after administration of either sevoflurane, desflurane, or propofol
- Τ180: 180 minutes after administration of either sevoflurane, desflurane, or propofol
- End of surgical procedure Phases TO, T30, T60, T180 and end of surgical procedures will be obtained with MAC= 0.8 for both volatile agents.
Phase T120 will be obtained with MAC= 1.2 for both volatile agents.
Blood samples for measuring S-100b, UCH-L1, GFAP will be obtained at phases T0, 6 hours, and 24 hours after administration of either sevoflurane, desflurane, or propofol Intraoperative consumption of volatile agents (sevoflurane or desflurane), propofol, and remifentanil will also be recorded.
Upon the opening of the dura matter the level of brain relaxation will be rated on a four-point scale (1. Completely relaxed, 2 sufficiently relaxed, 3 firm brain, 4 bulging brain) both by anesthesiologists and surgeons.
Awakening profile and emergence from anesthesia will be evaluated by the time needed for eye opening, response to verbal command, and extubation after discontinuation of administration of the anesthesia agent.
The Aldrete scoring system will be used for postanesthetic recovery assessment 30, 120 and 180 minutes during PACU stay. The Aldrete Scoring system consists of 5 clinically relevant parameters: muscle activity, respiration, circulation, consciousness and oxygen saturation.
Apfel score will be used for postoperative nausea and vomiting prediction. Any medication administered on PACU will be noted.
Recovery will be evaluated using two different scales. The Glasgow Outcome Scale- Extended (GOSE) assessment of global disability and recovery after traumatic brain injury will be applied both after PACU and hospital discharge. The quality of recovery- 40 is a 40-item questionnaire (QoR- 40) and will take place 24 hours postoperative and on discharge.
Neurocognitive testing will be performed at pre-anesthetic assessment, and 1 week after surgery completion using the Μontreal Cognitive Assessment (MoCA) scale.
- Conditions
- Brain Edema Caused by Drugs, Cerebral Oxygenation
- Being tested
- Sevoflurane, Desflurane
- Keywords
- sevoflurane, desflurane, total intravenous anesthesia, brain edema, brain oxygenation, neurocognitive outcome
- Medical subject headings
- Brain Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SevofluraneDrug
Sevoflurane will be administered at concentrations maintaining MAC= 0.8 for the first 60 minutes , MAC=1.2 for the next 60 minutes and MAC= 0.8 until surgery completion.
DesfluraneDrug
Also called Suprane
Desflurane will be administered at concentrations maintaining MAC= 0.8 for the first 60 minutes , MAC=1.2 for the next 60 minutes and MAC= 0.8 until surgery completion.
| Study group | Role | What they receive |
|---|---|---|
| Total intravenous anesthesia in brain tumor surgery | Active comparator | Propofol will be administered at concentrations maintaining BIS 40-60 up to surgery completion. Receives: Drug: Sevoflurane; Drug: Desflurane |
| Sevoflurane in brain tumor surgery | Experimental | Sevoflurane will be administered at concentrations maintaining MAC= 0.8 for the first 60 minutes , MAC=1.2 for the next 60 minutes and MAC= 0.8 until surgery completion. Receives: Drug: Desflurane |
| Desflurane in brain tumor surgery | Experimental | Desflurane will be administered at concentrations maintaining MAC= 0.8 for the first 60 minutes , MAC=1.2 for the next 60 minutes and MAC= 0.8 until surgery completion. Receives: Drug: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in jugular venous oxygen saturation
Alterations in jugular venous oxygen saturation (%), after administration of sevoflurane or desflurane or propofol as anesthetic agent
Measured: Time Frame: At baseline (start of propofol or sevoflurane or desflurane), 30 minutes, 60 minutes, 120 minutes, 180 minutes and at the end of surgical procedure
Secondary outcomes (5)
Changes in brain relaxation score
Alterations in BRS after administration of sevoflurane or desflurane or propofol as anesthetic agent
Measured: Before dura opening
Changes in Μontreal Cognitive Assessment (MoCA)
Alterations in Μontreal Cognitive Assessment (MoCA) after administration of sevoflurane or desflurane or propofol as anesthetic agent.
Measured: Preoperatively and one week following the end of surgical procedure
Changes in GFAP
Alterations in GFAP (ng/ml) levels after administration of sevoflurane or desflurane or propofol as anesthetic agent.
Measured: End of surgical procedure and 24 hours postoperatively
Changes in UCH-L1
Alterations in UCH-L1 (ng/ml) after administration of sevoflurane or desflurane or propofol as anesthetic agent
Measured: Baseline, end of surgical procedure and 24 hours postoperatively
Changes in S-100b protein
Alterations in S-100b (μg/L) after administration of sevoflurane or desflurane or propofol as anesthetic agent.
Measured: Baseline, end of surgical procedure and 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2025
- Study start12 May 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain Edema Caused by DrugsStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Georgia Tsaousi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Georgia Tsaousi, Aristotle University Of Thessaloniki
- Investigators
- Georgia Tsaousi, Professor, Principal investigator, Aristotle University Of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06779890
- Sponsor's protocol ID
- TIVAVolaBrain
- Acronym
- TIVolBrain
- Status last verified
- Sep 2025
- First submitted
- 8 Jan 2025
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Volatile-based Versus Total Intravenous Anesthesia on Cerebral Homeostasis and Neucognitive Function in Patients Undergoing Elective Craniotomy for Brain Tumor Excision.
- ClinicalTrials.gov ID
- NCT06779890
- Acronym / sponsor ID
- TIVolBrain / TIVAVolaBrain
- Conditions
- Brain Edema Caused by Drugs, Cerebral Oxygenation
- Keywords
- sevoflurane, desflurane, total intravenous anesthesia, brain edema, brain oxygenation, neurocognitive outcome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Georgia TsaousiUniversity, hospital or other
- Study start
- 12 May 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 17 Jan 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 brain is a metabolic active organ with constant energy demands. Brain oxygen supply is secured via cerebral circulation. Brain tumor surgery is commonly associated with the tumor's underlying pathophysiology including brain swelling or edema. During craniotomy for brain tumor resection maintenance of cerebral hemodynamic stability is of paramount importance. Neuroinflammation is also a normal response to trauma, such as in the case of brain tumor surgery. The role of neuroinflammation in postoperative brain function is well documented and the aim is to limit it through an appropriate anesthetic approach.
Anesthetic agents used during surgery affect brain homeostasis. The anesthetic agent of choice for neurosurgery should deliver smooth and hemodynamically stable anesthesia, good operating conditions, and allow early neurological assessment. Also, the ideal anesthetic agent should preserve cerebral perfusion and neuroprotection.
The two most common categories of anesthetic agents used nowadays for elective craniotomy are intravenous and inhalational agents.
Propofol is the intravenous anesthetic agent of choice. The action of propofol involves a positive modulation of the inhibitory function of the neurotransmitter gamma-aminobutyric acid (GABA). Propofol causes a decrease in cerebral metabolic rate (CMR), intracranial pressure (ICP), cerebral perfusion pressure (CPP), and cerebral blood flow (CBF). It also is known for its antiemetic properties.
Volatile agents commonly used in neuroanesthesia clinical practice are sevoflurane and desflurane. Both of these agents decrease CMR while maintaining stable CPP. CBF alteration is dose-dependent. Desflurane evokes a greater cerebral vasodilation effect than sevoflurane. Sevoflurane is a well-known neuroprotective anesthetic agent traditionally used in neurosurgery. Both desflurane and sevoflurane are associated with early emergence.
Thus, this study aimed to explore the effect of volatile-based versus total intravenous anesthesia on cerebral homeostasis and neurocognitive function in patients undergoing elective craniotomy for brain tumor excision aiming to provide a basis for clinical rational drug use in patients undergoing craniotomy resection of supratentorial lesions.
Detailed description
Each participant will receive standard monitoring (ECG, SpO2, SBP, BIS, urine output, temperature). More detailed hemodynamic monitoring will be obtained by the Edwards Lifesciences ClearSight system (CO, CI, SV, SVI, SVV, SVR, SVRI), while the analgesic efficacy of remifentanil will be assessed by Nociception index (NOL) monitoring.
TCI Remifentanil and propofol 2 mg/kg bolus dose will be the agents of choice for induction in anesthesia and cisatracurium will be used for neuromuscular blockade for intubation, while maintenance of anesthesia will be either volatile-based (sevoflurane or desflurane in low flow anesthesia approach) or propofol-based (TCI mode).
Protective mechanical ventilation will be chosen (7ml/kg IBW) with a respiratory rate to obtain a PaCO2 of 35-40 mmHg. PEEP will be changed for the best PaO2/FiO2 ratio and FiO2 of choice will be 0.5.
The radial artery catheterization will be applied for direct blood pressure measurement and arterial blood gas sampling (pH, PaO2, PaCO2, HCO3, BE, osmolality, lactic acid, Hb, glucose, Na and K will be measured).
The jugular bulb ipsilateral to the craniotomy site will be catheterized for receiving blood samples for blood gas analysis. The following oxygenation and metabolic parameters / derivates will be registered or calculated: SjvO2, pH, PjvO2, PjvCO2, HCO3, BE, Osmolality, Lactic acid jv, Hb, Glucose, Na, K, AjvDO2, AjvCO2, O2ERbr, eRQbr, AjvDL, and LOI.
Phases
- T0: after jugular bulb cannulation
- T30: 30 minutes after administration of either sevoflurane, desflurane, or propofol
- T60: 60 minutes after administration of either sevoflurane, desflurane, or propofol
- T120: 120 minutes after administration of either sevoflurane, desflurane, or propofol
- Τ180: 180 minutes after administration of either sevoflurane, desflurane, or propofol
- End of surgical procedure Phases TO, T30, T60, T180 and end of surgical procedures will be obtained with MAC= 0.8 for both volatile agents.
Phase T120 will be obtained with MAC= 1.2 for both volatile agents.
Blood samples for measuring S-100b, UCH-L1, GFAP will be obtained at phases T0, 6 hours, and 24 hours after administration of either sevoflurane, desflurane, or propofol Intraoperative consumption of volatile agents (sevoflurane or desflurane), propofol, and remifentanil will also be recorded.
Upon the opening of the dura matter the level of brain relaxation will be rated on a four-point scale (1. Completely relaxed, 2 sufficiently relaxed, 3 firm brain, 4 bulging brain) both by anesthesiologists and surgeons.
Awakening profile and emergence from anesthesia will be evaluated by the time needed for eye opening, response to verbal command, and extubation after discontinuation of administration of the anesthesia agent.
The Aldrete scoring system will be used for postanesthetic recovery assessment 30, 120 and 180 minutes during PACU stay. The Aldrete Scoring system consists of 5 clinically relevant parameters: muscle activity, respiration, circulation, consciousness and oxygen saturation.
Apfel score will be used for postoperative nausea and vomiting prediction. Any medication administered on PACU will be noted.
Recovery will be evaluated using two different scales. The Glasgow Outcome Scale- Extended (GOSE) assessment of global disability and recovery after traumatic brain injury will be applied both after PACU and hospital discharge. The quality of recovery- 40 is a 40-item questionnaire (QoR- 40) and will take place 24 hours postoperative and on discharge.
Neurocognitive testing will be performed at pre-anesthetic assessment, and 1 week after surgery completion using the Μontreal Cognitive Assessment (MoCA) scale.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Total intravenous anesthesia in brain tumor surgery | Active comparator | Drug: Sevoflurane, Drug: DesfluranePropofol will be administered at concentrations maintaining BIS 40-60 up to surgery completion. |
| Sevoflurane in brain tumor surgery | Experimental | Drug: DesfluraneSevoflurane will be administered at concentrations maintaining MAC= 0.8 for the first 60 minutes , MAC=1.2 for the next 60 minutes and MAC= 0.8 until surgery completion. |
| Desflurane in brain tumor surgery | Experimental | Drug: SevofluraneDesflurane will be administered at concentrations maintaining MAC= 0.8 for the first 60 minutes , MAC=1.2 for the next 60 minutes and MAC= 0.8 until surgery completion. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA-PS 1-3 (American Society of Anesthesiologists Physical Status classification)
- Elective or semi-elective craniotomy for brain tumor resection
- Signed informed consent
Key exclusion criteria (8 listed)
- History of craniotomy at the same site
- Morbid obesity
- Delirious person before surgery
- Cognitive disturbances
- Preoperative heart rate (HR) <45 beats/min or second or third degree AV block
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 |
|---|---|---|
| SevofluraneSevoflurane will be administered at concentrations maintaining MAC= 0.8 for the first 60 minutes , MAC=1.2 for the next 60 minutes and MAC= 0.8 until surgery completion. | Drug | Desflurane in brain tumor surgery, Total intravenous anesthesia in brain tumor surgery |
| DesfluraneAlso: SupraneDesflurane will be administered at concentrations maintaining MAC= 0.8 for the first 60 minutes , MAC=1.2 for the next 60 minutes and MAC= 0.8 until surgery completion. | Drug | Sevoflurane in brain tumor surgery, Total intravenous anesthesia in brain tumor surgery |
Primary outcome
Changes in jugular venous oxygen saturation
Time frame: Time Frame: At baseline (start of propofol or sevoflurane or desflurane), 30 minutes, 60 minutes, 120 minutes, 180 minutes and at the end of surgical procedure
Alterations in jugular venous oxygen saturation (%), after administration of sevoflurane or desflurane or propofol as anesthetic agent
5 secondary outcomes
Changes in brain relaxation score
Time frame: Before dura opening
Changes in Μontreal Cognitive Assessment (MoCA)
Time frame: Preoperatively and one week following the end of surgical procedure
Changes in GFAP
Time frame: End of surgical procedure and 24 hours postoperatively
Changes in UCH-L1
Time frame: Baseline, end of surgical procedure and 24 hours postoperatively
Changes in S-100b protein
Time frame: Baseline, end of surgical procedure and 24 hours postoperatively
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 1 Oct 2025.
- Individual participant dataSharing planned: No
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.
Georgia Tsaousi, Professor principal investigator
Aristotle University Of Thessaloniki
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Sevoflurane and Desflurane in people with Brain Edema Caused by Drugs and Cerebral Oxygenation, run by Georgia Tsaousi at 2 sites in Greece.
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 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 1 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Greece. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Georgia Tsaousi, Professor (+302310994855, tsaousig@otenet.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in jugular venous oxygen saturation (time frame: Time Frame: At baseline (start of propofol or sevoflurane or desflurane), 30 minutes, 60 minutes, 120 minutes, 180 minutes and at the end of surgical procedure). 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 1 Oct 2025.