Post-Dural Puncture HeadacheNCT05637645
Different Approaches of Spinal Anesthesia in Patients Undergoing Cesarean Section
A study testing Midline Approach, Paramedian Approach and Taylors approach in people with Post-Dural Puncture Headache and Hypotension, run by Bahawal Victoria Hospital Bahawalpur at 4 sites in Pakistan.
Trial summary
The goal of this clinical trial is to compare different approaches of spinal anesthesia in pregnant females who are having cesarean section. The main aim is Which approach is better in terms of avoiding intraoperative and post operative complications Participants will be given anesthesia by 1. Midline approach 2. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post-Dural Puncture Headache, Hypotension, Spinal Shock
- What is being tested?
- Midline Approach, Paramedian Approach and Taylors approach
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 4 sitesPakistan
- Study dates
- 22 Nov 2022to 31 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- Patients who refuse to participate in study.
- More than 3 attempts of lumber puncture
- Previously having migraines of PDPH
- Hb less than 7
- INR more than 1.2
- Previous C-section more than 5
Show all 9Show fewer
- Patients with placenta previa, accrete, percreta and increta
- NPO less than 6 hours preoperatively
- Patients from gynecological department other than C-section
Trial locations and contacts
4 sites in 1 country.
Pakistan4 sites, 4 recruiting
- Recruiting
Bahawal Victoria Hospital Bahawalpur
Bahawalpur, Punjab Province, 63100
Prof. Dr. Soufia Farrukh, FCPS, FRCS, (062) 2731042, info.students@qamc.edu.pk
Fawad Mueen Arbi, MBBS
- Recruiting
Bahawalpur Medical & Dental College Bahawalpur
Bahawalpur, Punjab Province, 63100
Prof Dr Ijaz Latif, MBBS, FCPS, +92 300 1478769, admissions@bmdc.edu.pk
Muhammad Ali Fayyaz, MBBS, BSC
- Recruiting
Hameed Latif Hospital
Lahore, Punjab Province, 54660
Yousaf Latif, MBBS, FCPS, 042111000043, info@hameedlatifhospital.com
Mueez Haider, MBBS
- Recruiting
Laeeque Rafiq Hospital (LRH) Multan
Multan, Punjab Province, 61000
Ch. Muhammad Rafiq, (061) 6529860, info@lrhospital.org
Muhammad Anees ur rehman, MBBS, BSC
About this study
Official title: Different Approaches of Spinal Anesthesia in Patients Undergoing Cesarean Section: Midline, Paramedian and Taylors Approach
The goal of this clinical trial is to compare different approaches of spinal anesthesia in pregnant females who are having cesarean section. The main aim is
- Which approach is better in terms of avoiding intraoperative and post operative complications
Participants will be given anesthesia by
- Midline approach
- paramedian approach
- Taylors approach
Read the detailed description
- Introduction to study: Different techniques and modalities are used to anesthetize the patient for the smooth conduction of surgery including, general anesthesia, spinal anesthesia, different types of regional anesthesia and monitored anesthesia care.1 According to the authors' knowledge, limited local studies are available that compare midline to the paramedian approach, Taylor's approach and Transforaminal approach of spinal anesthesia in the context of occurrence of post-dural puncture headaches, backache, hematoma, paresthesia, pulse, blood pressure, respiratory rate, temperature and urine output.3
- Problem statement: Post-dural puncture headache is defined as a bilateral headache that develops within 7 days after dural puncture. It characteristically worsens 15 minutes after resuming sitting position and improves or disappears within 30 minutes of resuming supine position. It can be managed with medical as well as autologous epidural blood patch. It may result in prolonged recovery and delayed mobilization as well as psychosomatic side effects. More sinister side effects like subdural hematoma and seizures are rare but may prove fatal.2 The exact mechanism of development of postdural puncture headache is unclear. The postulated pathogenesis involves cerebrospinal fluid (CSF) leak through the dural puncture site resulting in intracranial hypotension leading to traction on intracranial structures and vasodilatation of cerebral vessels resulting in headache.2
- Objectives of this research:
- To find out frequency of Post-dural puncture headache (PDPH) in patients with different groups undergoing different approaches of spinal anesthesia. ii) Impact of different approaches of spinal anesthesia on complications of spinal anesthesia. Complications are related to either exaggerated physiologic responses or needle/catheter insertion and include:
- Post-dural-puncture headache (PDPH)
- Hypotension and bradycardia secondary to sympathetic blockade
- Hypothermia
- Respiratory failure resulting from a "high spinal/block"
- Urinary retention
- Spinal infection, including aseptic meningitis
- Spinal or epidural hematoma
- Nerve or spinal cord damage, possibly resulting in paralysis
- Pain iii) Impact of different approaches of spinal anesthesia on vitals (pulse, BP, temperature, respiratory rate, spO2 and urine output) intraoperatively and postoperatively.
- Limitation of the study: The study will be limited to patients undergoing cesarean section. No general population will be involved.
- Methodology Paper based questionnaire will be filled out by doctors on duty during pre-operative, operative and post operative period of patients. The study will be a comparative study based on CONSORT randomized control trial in which different groups based on approaches i.e. midline, paramedian, Taylor's and transforaminal approach, will be made. Sampling will involve lottery method. Data will be analyzed by IBM SPSS Statistics Digital Software version 20.0. Data analysis will be done by comparing different groups based on approaches i.e. midline, paramedian, Taylor's and transforaminal approach.
Exclusion Criteria
- Patients who refuse to participate in study.
- More than 3 attempts of lumber puncture
- Previously having migraines of PDPH
- Hb less than 7
- INR more than 1.2
- Previous C-section more than 5
- Patients with placenta previa, accrete, percreta and increta
- NPO less than 6 hours preoperatively
- Patients from gynecological department other than C-section
Study Setting:
Emergency Operation Theatre, Bahawal Victoria Hospital, Bahawlpur.
- Ethical Consideration Points:
- Applied for ERC approval at DME QMC.
- Obtained written consent from study participants.
- Given autonomy to study participants.
- Maintained confidentiality of the data obtained.
- Given some beneficial effects to study participants.
- No harm to study participants.
- Non-maleficence.
- Justice and fair play.
- No conflict of interest among study authors.
- Study funding source mentioned if received from outside, other than study authors.
- Appropriate treatment availability at our institution for diseased subjects.
- In case of any referral, arrangements for it would be done.
- Study results dissemination to study participants would be done.
- Plagiarism check report within appreciate limits (less than 20%) is checked by given HEC licensed criteria.
- Contribution of each author made in conducting the study is mentioned with his/her name, proper designation and contact number/email.
- Conditions
- Post-Dural Puncture Headache, Hypotension, Spinal Shock, Hematoma, Bradycardia, Meningitis
- Being tested
- Midline Approach, Paramedian Approach, Taylors approach
- Keywords
- Midline approach, Spinal anesthesia, cesarean section, Taylors approach
- Medical subject headings
- Post-Dural Puncture Headache, Hypotension, Hematoma, Bradycardia, Meningitis, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Midline ApproachProcedure or surgery
Also called Spinal needle, Bupivacaine
In the midline approach, the spinal approach to the intrathecal space is midline with a straight line shot. After infiltration with lidocaine, the spinal needle is introduced into the skin, angled slightly cephalic. The needle traverses the skin, followed by subcutaneous fat. A single dose of 12.5mg of 0.5% bupivacaine (preservative free) will be used for the spinal anesthetic, the effects of this will last approximately 2 hours.
Paramedian ApproachProcedure or surgery
Also called Spinal needle, Bupivacaine
The paramedian approach involves inserting the spinal needle 1 cm away from the midline in medial direction. A single dose of 12.5mg of 0.5% bupivacaine (preservative free) will be used for the spinal anesthetic, the effects of this will last approximately 2 hours.
Taylors approachProcedure or surgery
Also called Spinal needle, Bupivacaine
his arm will have the procedure of spinal anesthetic performed via 'Taylor's approach' which is a paramedian approach to interspace L5 - S1. A single dose of 12.5mg of 0.5% bupivacaine (preservative free) will be used for the spinal anesthetic, the effects of this will last approximately 2 hours.
| Study group | Role | What they receive |
|---|---|---|
| Group M | Active comparator | It will involve participants who are given spinal anesthesia through midline approach. Receives: Procedure: Midline Approach |
| Group P | Active comparator | It will involve participants who are given spinal anesthesia through paramedian approach. Receives: Procedure: Paramedian Approach |
| Group T | Active comparator | It will involve participants who are given spinal anesthesia through Taylors approach. Receives: Procedure: Taylors approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-dural-puncture headache (PDPH)
PDPH is the most common complication after spinal anesthesia. Our study is based on prevention of PDPH using different approach in spinal anesthesia
Measured: 1 month
Secondary outcomes (7)
Hypotension and bradycardia secondary to sympathetic blockade
Measured: 1 day
Hypothermia
Measured: 1 day
Respiratory failure
Measured: 5 days
Spinal Shock
Measured: 1 day
Urinary retention
Measured: 1 month
Meningitis
Measured: 1 month
Hematoma
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2022
- Study start22 Nov 2022
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Post-Dural Puncture HeadacheStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to three groups in parallel for the duration of the study Group M for participants are given spinal anesthesia through Midline approach Group P for participants are given spinal anesthesia through Paramedian approach Group T for participants are given spinal anesthesia through Taylors approach
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bahawal Victoria Hospital Bahawalpur
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Ali Fayyaz, Bahawal Victoria Hospital Bahawalpur
- Investigators
- Muhammad Ali Fayyaz, MBBS, BSC, Principal investigator, Bahawal Victoria Hospital Bahawalpur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05637645
- Sponsor's protocol ID
- 1229/DME/QAMC Bahawalpur
- Status last verified
- Dec 2022
- First submitted
- 21 Nov 2022
- Last updated
- 9 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This clinical trial is going to be publish in an international journal. To prevent the data from being available to every researcher will not make any difference.
Publications
Hempel V. [Spinal anesthesia for cesarean section]. Anasthesiol Intensivmed Notfallmed Schmerzther. 2001 Jan;36(1):57-60. doi: 10.1055/s-2001-10239-8. German.
PubMed 11227314Buddeberg BS, Bandschapp O, Girard T. Post-dural puncture headache. Minerva Anestesiol. 2019 May;85(5):543-553. doi: 10.23736/S0375-9393.18.13331-1. Epub 2019 Jan 4.
PubMed 30621376Fernandes NL, Dyer RA. Anesthesia for Urgent Cesarean Section. Clin Perinatol. 2019 Dec;46(4):785-799. doi: 10.1016/j.clp.2019.08.010. Epub 2019 Aug 14.
PubMed 31653308Bernstein K, Hussey H, Hussey P, Gordo K, Landau R. Neuro-anesthesiology in pregnancy. Handb Clin Neurol. 2020;171:193-204. doi: 10.1016/B978-0-444-64239-4.00010-2.
PubMed 32736750Parikh KS, Seetharamaiah S. Approach to failed spinal anaesthesia for caesarean section. Indian J Anaesth. 2018 Sep;62(9):691-697. doi: 10.4103/ija.IJA_457_18.
PubMed 30237594
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Different Approaches of Spinal Anesthesia in Patients Undergoing Cesarean Section: Midline, Paramedian and Taylors Approach
- ClinicalTrials.gov ID
- NCT05637645
- Acronym / sponsor ID
- 1229/DME/QAMC Bahawalpur
- Conditions
- Post-Dural Puncture Headache, Hypotension, Spinal Shock, Hematoma, Bradycardia, Meningitis
- Keywords
- Midline approach, Spinal anesthesia, cesarean section, Taylors approach
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Bahawal Victoria Hospital BahawalpurUniversity, hospital or other
- Study start
- 22 Nov 2022 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Jan 2023 (estimated)
- First posted
- 5 Dec 2022 (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 goal of this clinical trial is to compare different approaches of spinal anesthesia in pregnant females who are having cesarean section. The main aim is
- Which approach is better in terms of avoiding intraoperative and post operative complications
Participants will be given anesthesia by
- Midline approach
- paramedian approach
- Taylors approach
Detailed description
- Introduction to study: Different techniques and modalities are used to anesthetize the patient for the smooth conduction of surgery including, general anesthesia, spinal anesthesia, different types of regional anesthesia and monitored anesthesia care.1 According to the authors' knowledge, limited local studies are available that compare midline to the paramedian approach, Taylor's approach and Transforaminal approach of spinal anesthesia in the context of occurrence of post-dural puncture headaches, backache, hematoma, paresthesia, pulse, blood pressure, respiratory rate, temperature and urine output.3
- Problem statement: Post-dural puncture headache is defined as a bilateral headache that develops within 7 days after dural puncture. It characteristically worsens 15 minutes after resuming sitting position and improves or disappears within 30 minutes of resuming supine position. It can be managed with medical as well as autologous epidural blood patch. It may result in prolonged recovery and delayed mobilization as well as psychosomatic side effects. More sinister side effects like subdural hematoma and seizures are rare but may prove fatal.2 The exact mechanism of development of postdural puncture headache is unclear. The postulated pathogenesis involves cerebrospinal fluid (CSF) leak through the dural puncture site resulting in intracranial hypotension leading to traction on intracranial structures and vasodilatation of cerebral vessels resulting in headache.2
- Objectives of this research:
- To find out frequency of Post-dural puncture headache (PDPH) in patients with different groups undergoing different approaches of spinal anesthesia. ii) Impact of different approaches of spinal anesthesia on complications of spinal anesthesia. Complications are related to either exaggerated physiologic responses or needle/catheter insertion and include:
- Post-dural-puncture headache (PDPH)
- Hypotension and bradycardia secondary to sympathetic blockade
- Hypothermia
- Respiratory failure resulting from a "high spinal/block"
- Urinary retention
- Spinal infection, including aseptic meningitis
- Spinal or epidural hematoma
- Nerve or spinal cord damage, possibly resulting in paralysis
- Pain iii) Impact of different approaches of spinal anesthesia on vitals (pulse, BP, temperature, respiratory rate, spO2 and urine output) intraoperatively and postoperatively.
- Limitation of the study: The study will be limited to patients undergoing cesarean section. No general population will be involved.
- Methodology Paper based questionnaire will be filled out by doctors on duty during pre-operative, operative and post operative period of patients. The study will be a comparative study based on CONSORT randomized control trial in which different groups based on approaches i.e. midline, paramedian, Taylor's and transforaminal approach, will be made. Sampling will involve lottery method. Data will be analyzed by IBM SPSS Statistics Digital Software version 20.0. Data analysis will be done by comparing different groups based on approaches i.e. midline, paramedian, Taylor's and transforaminal approach.
Exclusion Criteria
- Patients who refuse to participate in study.
- More than 3 attempts of lumber puncture
- Previously having migraines of PDPH
- Hb less than 7
- INR more than 1.2
- Previous C-section more than 5
- Patients with placenta previa, accrete, percreta and increta
- NPO less than 6 hours preoperatively
- Patients from gynecological department other than C-section
Study Setting:
Emergency Operation Theatre, Bahawal Victoria Hospital, Bahawlpur.
- Ethical Consideration Points:
- Applied for ERC approval at DME QMC.
- Obtained written consent from study participants.
- Given autonomy to study participants.
- Maintained confidentiality of the data obtained.
- Given some beneficial effects to study participants.
- No harm to study participants.
- Non-maleficence.
- Justice and fair play.
- No conflict of interest among study authors.
- Study funding source mentioned if received from outside, other than study authors.
- Appropriate treatment availability at our institution for diseased subjects.
- In case of any referral, arrangements for it would be done.
- Study results dissemination to study participants would be done.
- Plagiarism check report within appreciate limits (less than 20%) is checked by given HEC licensed criteria.
- Contribution of each author made in conducting the study is mentioned with his/her name, proper designation and contact number/email.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 3
- Model description
- Participants are assigned to three groups in parallel for the duration of the study Group M for participants are given spinal anesthesia through Midline approach Group P for participants are given spinal anesthesia through Paramedian approach Group T for participants are given spinal anesthesia through Taylors approach
| Arm | Type | Receives |
|---|---|---|
| Group M | Active comparator | Procedure: Midline ApproachIt will involve participants who are given spinal anesthesia through midline approach. |
| Group P | Active comparator | Procedure: Paramedian ApproachIt will involve participants who are given spinal anesthesia through paramedian approach. |
| Group T | Active comparator | Procedure: Taylors approachIt will involve participants who are given spinal anesthesia through Taylors approach. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (9 listed)
- Patients who refuse to participate in study.
- More than 3 attempts of lumber puncture
- Previously having migraines of PDPH
- Hb less than 7
- INR more than 1.2
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 |
|---|---|---|
| Midline ApproachAlso: Spinal needle, BupivacaineIn the midline approach, the spinal approach to the intrathecal space is midline with a straight line shot. After infiltration with lidocaine, the spinal needle is introduced into the skin, angled slightly cephalic. The needle traverses the skin, followed by subcutaneous fat. A single dose of 12.5mg of 0.5% bupivacaine (preservative free) will be used for the spinal anesthetic, the effects of this will last approximately 2 hours. | Procedure or surgery | Group M |
| Paramedian ApproachAlso: Spinal needle, BupivacaineThe paramedian approach involves inserting the spinal needle 1 cm away from the midline in medial direction. A single dose of 12.5mg of 0.5% bupivacaine (preservative free) will be used for the spinal anesthetic, the effects of this will last approximately 2 hours. | Procedure or surgery | Group P |
| Taylors approachAlso: Spinal needle, Bupivacainehis arm will have the procedure of spinal anesthetic performed via 'Taylor's approach' which is a paramedian approach to interspace L5 - S1. A single dose of 12.5mg of 0.5% bupivacaine (preservative free) will be used for the spinal anesthetic, the effects of this will last approximately 2 hours. | Procedure or surgery | Group T |
Primary outcome
Post-dural-puncture headache (PDPH)
Time frame: 1 month
PDPH is the most common complication after spinal anesthesia. Our study is based on prevention of PDPH using different approach in spinal anesthesia
7 secondary outcomes
Hypotension and bradycardia secondary to sympathetic blockade
Time frame: 1 day
Hypothermia
Time frame: 1 day
Respiratory failure
Time frame: 5 days
Spinal Shock
Time frame: 1 day
Urinary retention
Time frame: 1 month
Meningitis
Time frame: 1 month
Hematoma
Time frame: 5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2022.
- Results publication: PubMed 11227314Hempel V. [Spinal anesthesia for cesarean section]. Anasthesiol Intensivmed Notfallmed Schmerzther. 2001 Jan;36(1):57-60. doi: 10.1055/s-2001-10239-8. German.
- Results publication: PubMed 30621376Buddeberg BS, Bandschapp O, Girard T. Post-dural puncture headache. Minerva Anestesiol. 2019 May;85(5):543-553. doi: 10.23736/S0375-9393.18.13331-1. Epub 2019 Jan 4.
- Results publication: PubMed 31653308Fernandes NL, Dyer RA. Anesthesia for Urgent Cesarean Section. Clin Perinatol. 2019 Dec;46(4):785-799. doi: 10.1016/j.clp.2019.08.010. Epub 2019 Aug 14.
- Results publication: PubMed 32736750Bernstein K, Hussey H, Hussey P, Gordo K, Landau R. Neuro-anesthesiology in pregnancy. Handb Clin Neurol. 2020;171:193-204. doi: 10.1016/B978-0-444-64239-4.00010-2.
- Results publication: PubMed 30237594Parikh KS, Seetharamaiah S. Approach to failed spinal anaesthesia for caesarean section. Indian J Anaesth. 2018 Sep;62(9):691-697. doi: 10.4103/ija.IJA_457_18.
- Individual participant dataSharing planned: No. This clinical trial is going to be publish in an international journal. To prevent the data from being available to every researcher will not make any difference.
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Oral Gabapentin Versus Intravenous Neostigmine/Atropine Versus Combination of Both for Prevention of PDPH
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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.
Muhammad Ali Fayyaz, MBBS, BSC principal investigator
Bahawal Victoria Hospital Bahawalpur
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Midline Approach, Paramedian Approach and Taylors approach in people with Post-Dural Puncture Headache and Hypotension, run by Bahawal Victoria Hospital Bahawalpur at 4 sites in Pakistan.
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 0 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 9 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Pakistan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Muhammad Ali Fayyaz, MBBS, BSC (03360769913, mafayyazbonamana1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-dural-puncture headache (PDPH) (time frame: 1 month). 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 NCT05637645, which also lists 5 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 9 Dec 2022.