Adverse EffectNCT06871449
Investigation Of The Effects Of Unilateral And Bilateral Spinal Anesthesia On Cerebral Blood Flow
An observational study of Adverse Effect and Cerebral Perfusion, run by Nuh Naci Yazgan University at 1 site in Turkey (Türkiye).
Trial summary
Spinal anesthesia is a widely used method in anesthesia practice. Unilateral spinal block refers to a neuroaxial technique that induces motor and sensory blockade on the surgical side. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Adverse Effect, Cerebral Perfusion
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Mar 2022to 27 Mar 2023
- Phase
- Observational
- 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 18 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: A total of 60 male volunteer patients, aged 18-65 years, scheduled for unilateral inguinal hernia surgery in the operating room of Kayseri City Hospital, were included.
Who may be able to join
- No coagulation disorders or prolonged bleeding times
- No infections at the injection site or systemic infections
- Ability to cooperate
- No history of opioid use or local anesthetic allergy
- No cardiovascular, respiratory, or metabolic diseases
- Hemoglobin levels >10 g/dL
- BMI <30
Who cannot join
- Coagulation disorders present
- Infections at the injection site or systemic infections
- Inability to cooperate
- History of opioid use or local anesthetic allergy
- Cardiovascular, respiratory, or metabolic diseases present
- Hemoglobin levels <10 g/dL
- BMI >30
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Nuh Naci Yazgan Üniversity Faculty of Dentistry
Kayseri, Kocasinan, 38000
About this study
Spinal anesthesia is a widely used method in anesthesia practice. Unilateral spinal block refers to a neuroaxial technique that induces motor and sensory blockade on the surgical side. While spinal anesthesia offers numerous advantages, it is associated with complications such as hypotension, headache, transient neurological symptoms, and meningitis. Among these, hypotension is the most common. To mitigate hemodynamic issues, intravenous fluid preloading and vasopressor use are standard practices in many centers.
This study aimed to compare regional cerebral oxygenation (rSO₂) values in patients undergoing unilateral and bilateral spinal blocks to identify the least complicated and most effective method. Minimizing complications can facilitate early mobilization, reduce hospital stays, and lower infection risks.
Read more
The study included 60 male patients (aged 18-65 years) scheduled for unilateral inguinal hernia surgery at Kayseri City Hospital. Inclusion criteria were the absence of coagulation disorders, infections, or systemic diseases, hemoglobin levels >10 g/dL, and BMI <30. Patients were randomized into two groups:
Group I: Unilateral spinal anesthesia with 15 mg hyperbaric bupivacaine. Patients were placed in a lateral position on the surgical side for 5 minutes, then moved to the supine position.
Group II: Bilateral spinal anesthesia with 15 mg hyperbaric bupivacaine. Patients were placed in the supine position for 5 minutes.
Sensory block levels were assessed using the pin-prick test, and motor blocks were evaluated with the Bromage scale. Surgery commenced when the sensory block reached the T10 level. Patient data, including age, BMI, hemoglobin, baseline systolic/diastolic blood pressure (SBP/DBP), mean arterial pressure (MAP), heart rate (HR), oxygen saturation (SpO₂), and rSO₂, were recorded before and after spinal anesthesia. SBP, DBP, MAP, HR, SpO₂, and rSO₂ values were monitored at 5-minute intervals for 30 minutes.
Read the detailed description
This study was conducted with the approval of the Kayseri City Hospital Scientific Research and Publication Ethics Committee (approval number: 2022/605). Written informed patient consent was obtained (A Guide to Good Clinical Practice, 609, Mehtap Balcı, 24.03.2022). This manuscript adheres to the applicable TITCK - Turkish Pharmaceutical and Medical Device Authority guideline. It was determined that meaningful results could be obtained with a minimum of eight patients by performing a power analysis.
A total of 60 male volunteer patients, aged 18-65 years, scheduled for unilateral inguinal hernia surgery in the Kayseri City Hospital operating room, were included. The inclusion criteria were the absence of coagulation disorders or prolonged bleeding times, no infections at the injection site or systemic infections, ability to cooperate, no history of opioid use or local anesthetic allergy, no cardiovascular, respiratory, or metabolic diseases, hemoglobin levels >10 g/dL, and BMI <30. Patients were randomly assigned to two groups of 30 each.
Before surgery, patients were informed about the procedure and the anesthesia method. After reading and signing the informed consent form, volunteer patients were brought to the operating table. Intravenous access was established for all patients, and non-invasive monitoring was initiated. Patients were placed in a seated position, and the intervention area was cleaned with 10% povidone-iodine. Under sterile conditions, a 22G (Quincke) spinal needle was slowly advanced into the L4-5 spinal interspace, and free, clear cerebrospinal fluid (CSF) flow was observed.
Group I: Spinal anesthesia was performed with 15 mg of hyperbaric bupivacaine (3 cc, Buvasin 0.5% Spinal Heavy), followed by placing the patient in a lateral position on the surgical side for 5 minutes and then switching to the supine position.
Group II: Spinal anesthesia was performed with 15 mg of hyperbaric bupivacaine (3 cc, Buvasin 0.5% Spinal Heavy), followed by placing the patient in the supine position for 5 minutes.
The sensory block level was assessed using the pin-prick test, and the motor block level was evaluated using the Bromage scale. Surgery commenced once the sensory block reached the T10 level. Throughout the surgery, all patients received 3 L/min of 100% oxygen via a face mask.
Groups:
Group I: Intrathecal 15 mg hyperbaric bupivacaine (3 cc), lateral position for 5 minutes.
Group II: Intrathecal 15 mg hyperbaric bupivacaine (3 cc), supine position for 5 minutes.
Data regarding the patients' demographic characteristics (age, height, weight, BMI), baseline hemoglobin (Hb), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), heart rate (HR), oxygen saturation (SpO₂), and regional cerebral oxygenation (rSO₂) were recorded before and after spinal anesthesia. SBP, DBP, MAP, HR, SpO₂, and rSO₂ values were recorded at 5, 10, 15, 20, 25, and 30 minutes after spinal anesthesia. The data obtained will be analyzed using SPSS 25. If the parametric assumptions (Shapiro-Wilk test) are met, a t-test will be applied to determine the significance of the difference between independent groups, and variance analysis (ANOVA) will be applied for repeated measurements within groups.
- Conditions
- Adverse Effect, Cerebral Perfusion
- Keywords
- Spinal Block, Near-Infrared Spectroscopy ,Cerebral Oxygenation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| unilateral Spinal Block(GroupI) | Group I: After appropriate area cleaning, under sterile conditions, the spinal space was accessed through the L4-L5 interspace, and 15 mg of hyperbaric bupivacaine (3 cc, Buvasin 0.5% Spinal Heavy) was administered following the observation of free, clear cerebrospinal fluid (CSF) flow. The patient was then kept in the lateral position on the surgical side for 5 minutes before being moved to the supine position. | |
| Bilateral Spinal Block (Group II) | Group II: After appropriate area cleaning, under sterile conditions, the spinal space was accessed through the L4-L5 interspace, and 15 mg of hyperbaric bupivacaine (3 cc, Buvasin 0.5% Spinal Heavy) was administered following the observation of free, clear cerebrospinal fluid (CSF) flow. The patient was then kept in the supine position for 5 minutes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regional Cerebral Oxygenation
rSO₂ values were monitored
Measured: 5-minute intervals for 30 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2025
- Study start27 Mar 2022
- Primary completion29 Nov 2022
- Study completion27 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Adverse EffectStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nuh Naci Yazgan University
- Sponsor type
- University, hospital or other
- Collaborators
- Kayseri City Hospital
- Responsible party
- Principal investigator, MEHTAP BALCI, Nuh Naci Yazgan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06871449
- Sponsor's protocol ID
- Mehtap Balcı
- Status last verified
- Mar 2025
- First submitted
- 19 Jan 2025
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Kusku A, Demir G, Cukurova Z, Eren G, Hergunsel O. Monitorization of the effects of spinal anaesthesia on cerebral oxygen saturation in elder patients using near-infrared spectroscopy. Braz J Anesthesiol. 2014 Jul-Aug;64(4):241-6. doi: 10.1016/j.bjane.2013.06.012. Epub 2013 Oct 18.
PubMed 24998107Nishikawa K, Hagiwara R, Nakamura K, Ishizeki J, Kubo K, Saito S, Goto F. The effects of the extent of spinal block on the BIS score and regional cerebral oxygen saturation in elderly patients: A prospective, randomized, and double-blinded study. J Clin Monit Comput. 2007 Apr;21(2):109-14. doi: 10.1007/s10877-006-9063-7. Epub 2007 Jan 10.
PubMed 17216322Minville V, Asehnoune K, Salau S, Bourdet B, Tissot B, Lubrano V, Fourcade O. The effects of spinal anesthesia on cerebral blood flow in the very elderly. Anesth Analg. 2009 Apr;108(4):1291-4. doi: 10.1213/ane.0b013e31819b073b.
PubMed 19299802Hoppenstein D, Zohar E, Ramaty E, Shabat S, Fredman B. The effects of general vs spinal anesthesia on frontal cerebral oxygen saturation in geriatric patients undergoing emergency surgical fixation of the neck of femur. J Clin Anesth. 2005 Sep;17(6):431-8. doi: 10.1016/j.jclinane.2004.09.013.
PubMed 16171663Hino A, Ueda S, Mizukawa N, Imahori Y, Tenjin H. Effect of hemodilution on cerebral hemodynamics and oxygen metabolism. Stroke. 1992 Mar;23(3):423-6. doi: 10.1161/01.str.23.3.423.
PubMed 1542907Sun S, Liu NH, Huang SQ. Role of cerebral oxygenation for prediction of hypotension after spinal anesthesia for caesarean section. J Clin Monit Comput. 2016 Aug;30(4):417-21. doi: 10.1007/s10877-015-9733-4. Epub 2015 Jul 18.
PubMed 26186992Aydin G, Sayan CD. Is body mass index a risk factor for low cerebral oxygenation during spinal anesthesia in women undergoing cesarean section? A preliminary study. Turk J Med Sci. 2019 Jun 18;49(3):854-861. doi: 10.3906/sag-1810-208.
PubMed 31190520Hirose N, Kondo Y, Maeda T, Suzuki T, Yoshino A. Relationship between regional cerebral blood volume and oxygenation and blood pressure during spinal anesthesia in women undergoing cesarean section. J Anesth. 2016 Aug;30(4):603-9. doi: 10.1007/s00540-016-2165-6. Epub 2016 Mar 24.
PubMed 27011334
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation Of The Effects Of Unilateral And Bilateral Spinal Anesthesia On Cerebral Blood Flow
- ClinicalTrials.gov ID
- NCT06871449
- Acronym / sponsor ID
- Mehtap Balcı
- Conditions
- Adverse Effect, Cerebral Perfusion
- Keywords
- Spinal Block, Near-Infrared Spectroscopy ,Cerebral Oxygenation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Nuh Naci Yazgan UniversityUniversity, hospital or other
- Collaborators
- Kayseri City Hospital
- Study start
- 27 Mar 2022 (actual)
- Primary completion
- 29 Nov 2022 (actual)
- Study completion
- 27 Mar 2023 (actual)
- First posted
- 12 Mar 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.
Spinal anesthesia is a widely used method in anesthesia practice. Unilateral spinal block refers to a neuroaxial technique that induces motor and sensory blockade on the surgical side. While spinal anesthesia offers numerous advantages, it is associated with complications such as hypotension, headache, transient neurological symptoms, and meningitis. Among these, hypotension is the most common. To mitigate hemodynamic issues, intravenous fluid preloading and vasopressor use are standard practices in many centers.
This study aimed to compare regional cerebral oxygenation (rSO₂) values in patients undergoing unilateral and bilateral spinal blocks to identify the least complicated and most effective method. Minimizing complications can facilitate early mobilization, reduce hospital stays, and lower infection risks.
The study included 60 male patients (aged 18-65 years) scheduled for unilateral inguinal hernia surgery at Kayseri City Hospital. Inclusion criteria were the absence of coagulation disorders, infections, or systemic diseases, hemoglobin levels >10 g/dL, and BMI <30. Patients were randomized into two groups:
Group I: Unilateral spinal anesthesia with 15 mg hyperbaric bupivacaine. Patients were placed in a lateral position on the surgical side for 5 minutes, then moved to the supine position.
Group II: Bilateral spinal anesthesia with 15 mg hyperbaric bupivacaine. Patients were placed in the supine position for 5 minutes.
Sensory block levels were assessed using the pin-prick test, and motor blocks were evaluated with the Bromage scale. Surgery commenced when the sensory block reached the T10 level. Patient data, including age, BMI, hemoglobin, baseline systolic/diastolic blood pressure (SBP/DBP), mean arterial pressure (MAP), heart rate (HR), oxygen saturation (SpO₂), and rSO₂, were recorded before and after spinal anesthesia. SBP, DBP, MAP, HR, SpO₂, and rSO₂ values were monitored at 5-minute intervals for 30 minutes.
Detailed description
This study was conducted with the approval of the Kayseri City Hospital Scientific Research and Publication Ethics Committee (approval number: 2022/605). Written informed patient consent was obtained (A Guide to Good Clinical Practice, 609, Mehtap Balcı, 24.03.2022). This manuscript adheres to the applicable TITCK - Turkish Pharmaceutical and Medical Device Authority guideline. It was determined that meaningful results could be obtained with a minimum of eight patients by performing a power analysis.
A total of 60 male volunteer patients, aged 18-65 years, scheduled for unilateral inguinal hernia surgery in the Kayseri City Hospital operating room, were included. The inclusion criteria were the absence of coagulation disorders or prolonged bleeding times, no infections at the injection site or systemic infections, ability to cooperate, no history of opioid use or local anesthetic allergy, no cardiovascular, respiratory, or metabolic diseases, hemoglobin levels >10 g/dL, and BMI <30. Patients were randomly assigned to two groups of 30 each.
Before surgery, patients were informed about the procedure and the anesthesia method. After reading and signing the informed consent form, volunteer patients were brought to the operating table. Intravenous access was established for all patients, and non-invasive monitoring was initiated. Patients were placed in a seated position, and the intervention area was cleaned with 10% povidone-iodine. Under sterile conditions, a 22G (Quincke) spinal needle was slowly advanced into the L4-5 spinal interspace, and free, clear cerebrospinal fluid (CSF) flow was observed.
Group I: Spinal anesthesia was performed with 15 mg of hyperbaric bupivacaine (3 cc, Buvasin 0.5% Spinal Heavy), followed by placing the patient in a lateral position on the surgical side for 5 minutes and then switching to the supine position.
Group II: Spinal anesthesia was performed with 15 mg of hyperbaric bupivacaine (3 cc, Buvasin 0.5% Spinal Heavy), followed by placing the patient in the supine position for 5 minutes.
The sensory block level was assessed using the pin-prick test, and the motor block level was evaluated using the Bromage scale. Surgery commenced once the sensory block reached the T10 level. Throughout the surgery, all patients received 3 L/min of 100% oxygen via a face mask.
Groups:
Group I: Intrathecal 15 mg hyperbaric bupivacaine (3 cc), lateral position for 5 minutes.
Group II: Intrathecal 15 mg hyperbaric bupivacaine (3 cc), supine position for 5 minutes.
Data regarding the patients' demographic characteristics (age, height, weight, BMI), baseline hemoglobin (Hb), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP), heart rate (HR), oxygen saturation (SpO₂), and regional cerebral oxygenation (rSO₂) were recorded before and after spinal anesthesia. SBP, DBP, MAP, HR, SpO₂, and rSO₂ values were recorded at 5, 10, 15, 20, 25, and 30 minutes after spinal anesthesia. The data obtained will be analyzed using SPSS 25. If the parametric assumptions (Shapiro-Wilk test) are met, a t-test will be applied to determine the significance of the difference between independent groups, and variance analysis (ANOVA) will be applied for repeated measurements within groups.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| unilateral Spinal Block(GroupI) | – | –Group I: After appropriate area cleaning, under sterile conditions, the spinal space was accessed through the L4-L5 interspace, and 15 mg of hyperbaric bupivacaine (3 cc, Buvasin 0.5% Spinal Heavy) was administered following the observation of free, clear cerebrospinal fluid (CSF) flow. The patient was then kept in the lateral position on the surgical side for 5 minutes before being moved to the supine position. |
| Bilateral Spinal Block (Group II) | – | –Group II: After appropriate area cleaning, under sterile conditions, the spinal space was accessed through the L4-L5 interspace, and 15 mg of hyperbaric bupivacaine (3 cc, Buvasin 0.5% Spinal Heavy) was administered following the observation of free, clear cerebrospinal fluid (CSF) flow. The patient was then kept in the supine position for 5 minutes. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 60 male volunteer patients, aged 18-65 years, scheduled for unilateral inguinal hernia surgery in the operating room of Kayseri City Hospital, were included.
Key inclusion criteria (7 listed)
- No coagulation disorders or prolonged bleeding times
- No infections at the injection site or systemic infections
- Ability to cooperate
- No history of opioid use or local anesthetic allergy
- No cardiovascular, respiratory, or metabolic diseases
Key exclusion criteria (7 listed)
- Coagulation disorders present
- Infections at the injection site or systemic infections
- Inability to cooperate
- History of opioid use or local anesthetic allergy
- Cardiovascular, respiratory, or metabolic diseases present
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Regional Cerebral Oxygenation
Time frame: 5-minute intervals for 30 minutes.
rSO₂ values were monitored
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Results publication: PubMed 24998107Kusku A, Demir G, Cukurova Z, Eren G, Hergunsel O. Monitorization of the effects of spinal anaesthesia on cerebral oxygen saturation in elder patients using near-infrared spectroscopy. Braz J Anesthesiol. 2014 Jul-Aug;64(4):241-6. doi: 10.1016/j.bjane.2013.06.012. Epub 2013 Oct 18.
- Results publication: PubMed 17216322Nishikawa K, Hagiwara R, Nakamura K, Ishizeki J, Kubo K, Saito S, Goto F. The effects of the extent of spinal block on the BIS score and regional cerebral oxygen saturation in elderly patients: A prospective, randomized, and double-blinded study. J Clin Monit Comput. 2007 Apr;21(2):109-14. doi: 10.1007/s10877-006-9063-7. Epub 2007 Jan 10.
- Results publication: PubMed 19299802Minville V, Asehnoune K, Salau S, Bourdet B, Tissot B, Lubrano V, Fourcade O. The effects of spinal anesthesia on cerebral blood flow in the very elderly. Anesth Analg. 2009 Apr;108(4):1291-4. doi: 10.1213/ane.0b013e31819b073b.
- Results publication: PubMed 16171663Hoppenstein D, Zohar E, Ramaty E, Shabat S, Fredman B. The effects of general vs spinal anesthesia on frontal cerebral oxygen saturation in geriatric patients undergoing emergency surgical fixation of the neck of femur. J Clin Anesth. 2005 Sep;17(6):431-8. doi: 10.1016/j.jclinane.2004.09.013.
- Results publication: PubMed 1542907Hino A, Ueda S, Mizukawa N, Imahori Y, Tenjin H. Effect of hemodilution on cerebral hemodynamics and oxygen metabolism. Stroke. 1992 Mar;23(3):423-6. doi: 10.1161/01.str.23.3.423.
- Results publication: PubMed 26186992Sun S, Liu NH, Huang SQ. Role of cerebral oxygenation for prediction of hypotension after spinal anesthesia for caesarean section. J Clin Monit Comput. 2016 Aug;30(4):417-21. doi: 10.1007/s10877-015-9733-4. Epub 2015 Jul 18.
- Results publication: PubMed 31190520Aydin G, Sayan CD. Is body mass index a risk factor for low cerebral oxygenation during spinal anesthesia in women undergoing cesarean section? A preliminary study. Turk J Med Sci. 2019 Jun 18;49(3):854-861. doi: 10.3906/sag-1810-208.
- Results publication: PubMed 27011334Hirose N, Kondo Y, Maeda T, Suzuki T, Yoshino A. Relationship between regional cerebral blood volume and oxygenation and blood pressure during spinal anesthesia in women undergoing cesarean section. J Anesth. 2016 Aug;30(4):603-9. doi: 10.1007/s00540-016-2165-6. Epub 2016 Mar 24.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adverse Effect and Cerebral Perfusion, run by Nuh Naci Yazgan University at 1 site in Turkey (Türkiye).
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 7 inclusion and 7 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: finished, as of the sponsor's last update on 12 Mar 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 Turkey (Türkiye). 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Regional Cerebral Oxygenation (time frame: 5-minute intervals for 30 minutes.). 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 NCT06871449, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2025.