Epidural HematomaPREDICT-AEDHNCT04261673
Prospective Randomized Evaluation of Decompressive Ipsilateral Craniectomy for Traumatic Acute Epidural Hematoma
A study testing Decompressive Craniectomy and Craniotomy in people with Epidural Hematoma and Brain Herniation, run by RenJi Hospital at 1 site in China.
Trial summary
Although craniotomy provides a more complete evacuation of the acute epidural hematoma, there are insufficient data to support specific surgical treatment method. We aim to perform a multi-center, parallel-group randomized clinical trial to compare the outcome and cost-effectiveness of decompressive craniectomy versus… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Epidural Hematoma, Brain Herniation, Decompressive Craniectomy
- What is being tested?
- Decompressive Craniectomy and Craniotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 23 May 2020to 31 Dec 2025
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clear medical history of traumatic brain injury;
- Within 12 hours after injury;
- Unilateral mydriasis or bilateral mydriasis before the operation;
- Acute supratentorial epidural hematoma and signs of brain stem compression on CT scan, representing the leading cause of operation, despite any other minor intracranial injuries associated (e.g., subarachnoid hemorrhage and contusion);
- The admitting neurosurgeon considers that the epidural hematoma needs to be evacuated with a craniotomy or decompressive craniectomy.
- With informed consent.
Who cannot join
- Previous intracranial surgery prior to trauma;
- Patients with a score of 3 on the GCS, with bilateral fixed and dilated pupils, bleeding diathesis or defective coagulation, or other injuries that were deemed to be unsurvivable;
- Patients who had injury of the oculomotor nerve;
- Patients are considered to be operated mainly by following pathological change on CT: subdural hematoma, intracerebral hemorrhage, large size infarction, et al., but not because of epidural hematoma;
- Severe pre-existing disability or severe co-morbidity which would lead to a poor outcome even if the patient is supposed to a good recovery from the TBI;
- Pregnant female.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Neurosurgery, Renji Hospital, School of Medicine, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality
About this study
Official title: A Randomised Controlled Trial to Evaluate Decompressive Craniectomy for Patients With Cerebral Herniation Undergoing Evacuation of Acute Epidural Hematoma
Although craniotomy provides a more complete evacuation of the acute epidural hematoma, there are insufficient data to support specific surgical treatment method. We aim to perform a multi-center, parallel-group randomized clinical trial to compare the outcome and cost-effectiveness of decompressive craniectomy versus craniotomy for the treatment of traumatic brain injury patients with cerebral herniation undergoing evacuation of an acute epidural hematoma.
Read the detailed description
The incidence of epidural hematoma (EDH) among traumatic brain injury (TBI) patients has been reported to be in the range of 2.7 to 4%. Among patients in coma, up to 9% harbored an EDH requiring craniotomy. The mortality in patients in all age groups and GCS scores undergoing surgery for evacuation of EDH is approximately 10%. The decision to operate on an acute EDH (AEDH) is usually based on the patient's GCS score, age, pupillary abnormalities, comorbidities, CT findings, associated intracranial lesions, in delayed decisions, the time between neurological deterioration and surgery, and intracranial pressure. An AEDH greater than 30 ml should be surgically evacuated regardless of the patient's Glasgow Coma Scale (GCS) score. There are insufficient data to support one surgical treatment method. However, craniotomy provides a more complete evacuation of the hematoma for patients with an AEDH that require an operation to remove the clot. But whether decompressive craniectomy (DC) should be employed still has considerable controversy. The choice of operative technique is influenced by the surgeon's expertise, training, and evaluation of a particular situation. The difference between these two procedures is that a bone flap is left out before closing the skin in DC. Both approaches are widely used among neurological surgeons (although the indications may differ), therefore there is sufficient experience in the centers to set up a randomized clinical trial.
- Being tested
- Decompressive Craniectomy, Craniotomy
- Medical subject headings
- Hematoma, Epidural, Spinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decompressive CraniectomyProcedure or surgery
A large bone flap must be raised. The evacuation of epidural hematoma is depended on surgeon's preference. The bone flap should not be replaced at the end of the operation. DC has an advantage in controlling brain swelling, but patient is necessary to have another operation of cranioplasty to reconstruct the skull in the future.
CraniotomyProcedure or surgery
A large bone flap must be raised. The evacuation of epidural hematoma is depended on surgeon's preference. However, the bone flap must be replaced and fixed with fixation system (plates and screws). The patient will not need an additional operation to rebuild the skull in the future. But undisciplinable brain swelling and increased intracranial pressure may happen in some patients, and additional decompressive craniectomy is recommended in these cases.
| Study group | Role | What they receive |
|---|---|---|
| Decompressive Craniectomy | Experimental | After the evacuation of epidural hematoma, the bone flap should not be replaced at the end of the operation. Receives: Procedure: Decompressive Craniectomy |
| Craniotomy | Experimental | After the evacuation of epidural hematoma, the bone flap must be replaced and fixed with an appropriate fixation system. Receives: Procedure: Craniotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
GOSE (extended Glasgow Outcome Scale) scores
The primary outcome is indicated by the long-term functional outcomes, including overall mortality and the score on the "Extended Glasgow Outcome Scale" (GOS-E). "Extended Glasgow Outcome Scale" is the unabbreviated scale title, minimum value is 1 and maximum value is 8, which was scored as follows and higher scores mean a better outcome:
- death;
- persistent vegetative state;
- lower severe disability;
- upper severe disability (stratum 3 and 4 were considered as severe disability, with permanent requirement for help with daily living);
- lower moderate disability;
- upper moderate disability (stratum 5 and 6 were considered as mild disability, without a need for assistance in everyday life, that might, however, require special equipment for employment);
- lower good recovery;
- upper good recovery (stratum 7 and 8 were considered as good recovery).
Measured: 6 months post-injury
Secondary outcomes (7)
incidence of post-operative cerebral infarction
Patients have clinical deterioration after an initial surgery because of post-operative cerebral infarction.
Measured: within 6 months post-injury
incidence of additional craniocerebral surgery
Patients have additional craniocerebral surgical operation as a result of clinical deterioration.
Measured: within 6 months post-injury
length of stay in hospital
The length of patient's stay in hospital after initial surgery, which must due to AEDH related medical treatment. Number of days in hospital are used to evaluate length, and patients with poor treatment effect may need longer hospital stays.
Measured: within 6 months post-injury
detailed economic evaluation
Total medical expense related to treatment of AEDH, including the costs of operations, hospitalization and rehabilitation. Different operations have different medical expense，and patients with poor treatment effect may need more medical expense. We record and evaluate the total medical expense of the entire AEDH treatment process, within 6 months post-injury.
Measured: within 6 months post-injury
incidence of serious adverse events
Serious adverse events (SAE) is defined as an untoward occurrence that:
- results in death;
- is life-threatening;
- requires hospitalization or prolongation of existing hospitalization;
- results in persistent or significant disability or incapacity;
- is otherwise considered medically significant by the investigator.
Measured: within 6 months post-injury
quality of life (EQ-5D-5L)
Unabbreviated scale title is "5-level EuroQol five dimensions" questionnaire. The EQ-5D is a generic instrument for describing and valuing health. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
Measured: at 1,3 and 6 months post-injury
MMSE (mini-mental state examination) scores
Unabbreviated scale title is "mini-mental state examination", and minimum value is 0 and maximum value is 30. Higher scores mean a better outcome.
Measured: at 1,3 and 6 months post-injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2020
- Study start23 May 2020
- Primary completion14 Sep 2025
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Epidural HematomaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shenzhen Second People's Hospital, Clinical Research Institute, Shanghai Jiao Tong University School of Medicine
- Responsible party
- Sponsor
- Investigators
- Junfeng Feng, MD, Principal investigator, Department of Neurosurgery,Renji Hospital,School of Medicine,Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04261673
- Sponsor's protocol ID
- PREDICT-AEDH
- Acronym
- PREDICT-AEDH
- Status last verified
- Sep 2025
- First submitted
- 4 Feb 2020
- Last updated
- 1 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bullock MR, Chesnut R, Ghajar J, Gordon D, Hartl R, Newell DW, Servadei F, Walters BC, Wilberger JE; Surgical Management of Traumatic Brain Injury Author Group. Surgical management of acute epidural hematomas. Neurosurgery. 2006 Mar;58(3 Suppl):S7-15; discussion Si-iv.
PubMed 16710967Li LM, Kolias AG, Guilfoyle MR, Timofeev I, Corteen EA, Pickard JD, Menon DK, Kirkpatrick PJ, Hutchinson PJ. Outcome following evacuation of acute subdural haematomas: a comparison of craniotomy with decompressive craniectomy. Acta Neurochir (Wien). 2012 Sep;154(9):1555-61. doi: 10.1007/s00701-012-1428-8. Epub 2012 Jun 30.
PubMed 22752713Lin H, Wang WH, Hu LS, Li J, Luo F, Lin JM, Huang W, Zhang MS, Zhang Y, Hu K, Zheng JX. Novel Clinical Scale for Evaluating Pre-Operative Risk of Cerebral Herniation from Traumatic Epidural Hematoma. J Neurotrauma. 2016 Jun 1;33(11):1023-33. doi: 10.1089/neu.2014.3656. Epub 2016 Jan 28.
PubMed 25393339Wang WH, Hu LS, Lin H, Li J, Luo F, Huang W, Lin JM, Cai GP, Liu CC. Risk factors for post-traumatic massive cerebral infarction secondary to space-occupying epidural hematoma. J Neurotrauma. 2014 Aug 15;31(16):1444-50. doi: 10.1089/neu.2013.3142. Epub 2014 Jun 25.
PubMed 24773559Feng J, Yang C, Xie L, Jin D, Jiang Q, Wang Y, Zhong C, Huang X, Wang Q, Mao J, Song Y, Bao Y, Huang J, Long L, Luo D, Zhen Y, Zhang L, Yun Q, Liang R, Jia J, Zhao W, Fan X, Pan J, Bie L, Liu J, Zhang Y, Hao H, Tang W, Zhang J, Wang Z, Fang W, Yang L, He Z, Liu M, Jiang J; PREDICT-AEDH investigators. Safety and efficacy of decompressive craniectomy versus standard craniotomy for large acute epidural haematoma with tentorial herniation in China (PREDICT-AEDH): a nationwide, multicentre, open-label, parallel-group, randomised controlled trial. Lancet Neurol. 2026 Jul;25(7):645-653. doi: 10.1016/S1474-4422(26)00143-2.
PubMed 42309085Yang C, Huang X, Feng J, Xie L, Hui J, Li W, Jiang J. Prospective Randomized Evaluation of Decompressive Ipsilateral Craniectomy for Traumatic Acute Epidural Hematoma (PREDICT-AEDH): study protocol for a randomized controlled trial. Trials. 2021 Jun 29;22(1):421. doi: 10.1186/s13063-021-05359-6.
PubMed 34187537
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
- A Randomised Controlled Trial to Evaluate Decompressive Craniectomy for Patients With Cerebral Herniation Undergoing Evacuation of Acute Epidural Hematoma
- ClinicalTrials.gov ID
- NCT04261673
- Acronym / sponsor ID
- PREDICT-AEDH / PREDICT-AEDH
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Collaborators
- Shenzhen Second People's Hospital, Clinical Research Institute, Shanghai Jiao Tong University School of Medicine
- Study start
- 23 May 2020 (actual)
- Primary completion
- 14 Sep 2025 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 10 Feb 2020 (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.
Although craniotomy provides a more complete evacuation of the acute epidural hematoma, there are insufficient data to support specific surgical treatment method. We aim to perform a multi-center, parallel-group randomized clinical trial to compare the outcome and cost-effectiveness of decompressive craniectomy versus craniotomy for the treatment of traumatic brain injury patients with cerebral herniation undergoing evacuation of an acute epidural hematoma.
Detailed description
The incidence of epidural hematoma (EDH) among traumatic brain injury (TBI) patients has been reported to be in the range of 2.7 to 4%. Among patients in coma, up to 9% harbored an EDH requiring craniotomy. The mortality in patients in all age groups and GCS scores undergoing surgery for evacuation of EDH is approximately 10%. The decision to operate on an acute EDH (AEDH) is usually based on the patient's GCS score, age, pupillary abnormalities, comorbidities, CT findings, associated intracranial lesions, in delayed decisions, the time between neurological deterioration and surgery, and intracranial pressure. An AEDH greater than 30 ml should be surgically evacuated regardless of the patient's Glasgow Coma Scale (GCS) score. There are insufficient data to support one surgical treatment method. However, craniotomy provides a more complete evacuation of the hematoma for patients with an AEDH that require an operation to remove the clot. But whether decompressive craniectomy (DC) should be employed still has considerable controversy. The choice of operative technique is influenced by the surgeon's expertise, training, and evaluation of a particular situation. The difference between these two procedures is that a bone flap is left out before closing the skin in DC. Both approaches are widely used among neurological surgeons (although the indications may differ), therefore there is sufficient experience in the centers to set up a randomized clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Decompressive Craniectomy | Experimental | Procedure: Decompressive CraniectomyAfter the evacuation of epidural hematoma, the bone flap should not be replaced at the end of the operation. |
| Craniotomy | Experimental | Procedure: CraniotomyAfter the evacuation of epidural hematoma, the bone flap must be replaced and fixed with an appropriate fixation system. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Clear medical history of traumatic brain injury;
- Within 12 hours after injury;
- Unilateral mydriasis or bilateral mydriasis before the operation;
- Acute supratentorial epidural hematoma and signs of brain stem compression on CT scan, representing the leading cause of operation, despite any other minor intracranial injuries associated (e.g., subarachnoid hemorrhage and contusion);
- The admitting neurosurgeon considers that the epidural hematoma needs to be evacuated with a craniotomy or decompressive craniectomy.
Key exclusion criteria (6 listed)
- Previous intracranial surgery prior to trauma;
- Patients with a score of 3 on the GCS, with bilateral fixed and dilated pupils, bleeding diathesis or defective coagulation, or other injuries that were deemed to be unsurvivable;
- Patients who had injury of the oculomotor nerve;
- Patients are considered to be operated mainly by following pathological change on CT: subdural hematoma, intracerebral hemorrhage, large size infarction, et al., but not because of epidural hematoma;
- Severe pre-existing disability or severe co-morbidity which would lead to a poor outcome even if the patient is supposed to a good recovery from the TBI;
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 |
|---|---|---|
| Decompressive CraniectomyA large bone flap must be raised. The evacuation of epidural hematoma is depended on surgeon's preference. The bone flap should not be replaced at the end of the operation. DC has an advantage in controlling brain swelling, but patient is necessary to have another operation of cranioplasty to reconstruct the skull in the future. | Procedure or surgery | Decompressive Craniectomy |
| CraniotomyA large bone flap must be raised. The evacuation of epidural hematoma is depended on surgeon's preference. However, the bone flap must be replaced and fixed with fixation system (plates and screws). The patient will not need an additional operation to rebuild the skull in the future. But undisciplinable brain swelling and increased intracranial pressure may happen in some patients, and additional decompressive craniectomy is recommended in these cases. | Procedure or surgery | Craniotomy |
Primary outcome
GOSE (extended Glasgow Outcome Scale) scores
Time frame: 6 months post-injury
The primary outcome is indicated by the long-term functional outcomes, including overall mortality and the score on the "Extended Glasgow Outcome Scale" (GOS-E). "Extended Glasgow Outcome Scale" is the unabbreviated scale title, minimum value is 1 and maximum value is 8, which was scored as follows and higher scores mean a better outcome: 1. death; 2. persistent vegetative state; 3. lower severe disability; 4. upper severe disability (stratum 3 and 4 were considered as severe disability, with permanent requirement for help with daily living); 5. lower moderate disability; 6. upper moderate disability (stratum 5 and 6 were considered as mild disability, without a need for assistance in everyday life, that might, however, require special equipment for employment); 7. lower good recovery; 8. upper good recovery (stratum 7 and 8 were considered as good recovery).
7 secondary outcomes
incidence of post-operative cerebral infarction
Time frame: within 6 months post-injury
incidence of additional craniocerebral surgery
Time frame: within 6 months post-injury
length of stay in hospital
Time frame: within 6 months post-injury
detailed economic evaluation
Time frame: within 6 months post-injury
incidence of serious adverse events
Time frame: within 6 months post-injury
quality of life (EQ-5D-5L)
Time frame: at 1,3 and 6 months post-injury
MMSE (mini-mental state examination) scores
Time frame: at 1,3 and 6 months post-injury
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.
- Background: PubMed 16710967Bullock MR, Chesnut R, Ghajar J, Gordon D, Hartl R, Newell DW, Servadei F, Walters BC, Wilberger JE; Surgical Management of Traumatic Brain Injury Author Group. Surgical management of acute epidural hematomas. Neurosurgery. 2006 Mar;58(3 Suppl):S7-15; discussion Si-iv.
- Background: PubMed 22752713Li LM, Kolias AG, Guilfoyle MR, Timofeev I, Corteen EA, Pickard JD, Menon DK, Kirkpatrick PJ, Hutchinson PJ. Outcome following evacuation of acute subdural haematomas: a comparison of craniotomy with decompressive craniectomy. Acta Neurochir (Wien). 2012 Sep;154(9):1555-61. doi: 10.1007/s00701-012-1428-8. Epub 2012 Jun 30.
- Background: PubMed 25393339Lin H, Wang WH, Hu LS, Li J, Luo F, Lin JM, Huang W, Zhang MS, Zhang Y, Hu K, Zheng JX. Novel Clinical Scale for Evaluating Pre-Operative Risk of Cerebral Herniation from Traumatic Epidural Hematoma. J Neurotrauma. 2016 Jun 1;33(11):1023-33. doi: 10.1089/neu.2014.3656. Epub 2016 Jan 28.
- Background: PubMed 24773559Wang WH, Hu LS, Lin H, Li J, Luo F, Huang W, Lin JM, Cai GP, Liu CC. Risk factors for post-traumatic massive cerebral infarction secondary to space-occupying epidural hematoma. J Neurotrauma. 2014 Aug 15;31(16):1444-50. doi: 10.1089/neu.2013.3142. Epub 2014 Jun 25.
- Derived from this study: PubMed 42309085Feng J, Yang C, Xie L, Jin D, Jiang Q, Wang Y, Zhong C, Huang X, Wang Q, Mao J, Song Y, Bao Y, Huang J, Long L, Luo D, Zhen Y, Zhang L, Yun Q, Liang R, Jia J, Zhao W, Fan X, Pan J, Bie L, Liu J, Zhang Y, Hao H, Tang W, Zhang J, Wang Z, Fang W, Yang L, He Z, Liu M, Jiang J; PREDICT-AEDH investigators. Safety and efficacy of decompressive craniectomy versus standard craniotomy for large acute epidural haematoma with tentorial herniation in China (PREDICT-AEDH): a nationwide, multicentre, open-label, parallel-group, randomised controlled trial. Lancet Neurol. 2026 Jul;25(7):645-653. doi: 10.1016/S1474-4422(26)00143-2.
- Derived from this study: PubMed 34187537Yang C, Huang X, Feng J, Xie L, Hui J, Li W, Jiang J. Prospective Randomized Evaluation of Decompressive Ipsilateral Craniectomy for Traumatic Acute Epidural Hematoma (PREDICT-AEDH): study protocol for a randomized controlled trial. Trials. 2021 Jun 29;22(1):421. doi: 10.1186/s13063-021-05359-6.
- 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.
Junfeng Feng, MD principal investigator
Department of Neurosurgery,Renji Hospital,School of Medicine,Shanghai Jiao Tong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decompressive Craniectomy and Craniotomy in people with Epidural Hematoma and Brain Herniation, run by RenJi Hospital at 1 site in China.
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 6 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 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 1 site in China. 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?
GOSE (extended Glasgow Outcome Scale) scores (time frame: 6 months post-injury). 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 NCT04261673, which also lists 6 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 1 Oct 2025.