Ultrasonographic Evaluation of Epidural Depth in InfantsNCT07847762
Evaluation of Skin-to-Epidural Distance at Different Vertebral Levels by Ultrasonography in Infants: A Prospective Observational Study
An observational study of Ultrasonographic Evaluation of Epidural Depth in Infants, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
The goal of this observational study is to learn about the distance between the skin and the epidural space in infants younger than 12 months. The epidural space is an area near the spinal cord where doctors can give pain medicine to help control pain during and after surgery. Read more about this study
- Who is it for?
- Ages Up to 1 year
- Conditions the study is for
- Ultrasonographic Evaluation of Epidural Depth in Infants
- What is being tested?
- Ultrasonographic Assessment of Skin-to-Epidural Distance and Epidural Catheter Placement for Clinical Indications
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2026to 1 Nov 2027
- Phase
- Observational
- 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 Up to 1 year
- All sexes
- No healthy volunteers
- Child
Study population: Participants will be recruited from infants scheduled for elective surgical procedures at the operating rooms of the Department of Anesthesiology and Reanimation, Cerrahpaşa Faculty of Medicine, Istanbul University-Cerrahpaşa. The study population consists of infants undergoing routine perioperative evaluation under general anesthesia in a tertiary academic medical center.
Who may be able to join
- Infants aged 0 to 12 months
- Scheduled for elective surgery under general anesthesia
- American Society of Anesthesiologists physical status I to III
- Written informed consent obtained from parents or legal guardians
Who cannot join
- Known vertebral or spinal cord anomalies, including scoliosis or spina bifida
- Previous spinal surgery
- Neuromuscular disease or known spinal cord pathology
- Congenital syndromes associated with systemic malformations
- Severe pulmonary, cardiac, hemodynamic, or neurological instability
- Emergency surgery
- Unreliable or incomplete ultrasonographic measurement data due to technical difficulties
- Absence of written informed consent from parents or legal guardians
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Istanbul University Cerrahpasa, Cerrahpasa Medical Faculty
Istanbul, 34098
Bahar Inan, MD, +905387352525, bahar.inan@iuc.edu.tr
Pınar Kendigelen, MD, Professor, +905325868734, pinar.kendigelen@iuc.edu.tr
About this study
Official title: Evaluation of Skin-to-Epidural Distance With Ultrasonography at Different Vertebral Levels in Infants: A Prospective Observational Study
The goal of this observational study is to learn about the distance between the skin and the epidural space in infants younger than 12 months. The epidural space is an area near the spinal cord where doctors can give pain medicine to help control pain during and after surgery. Epidural pain treatment can greatly reduce the amount of pain a child feels after surgery. Researchers will use ultrasound, a method that uses sound waves to create images inside the body and does not have harmful effects on the body, to measure this distance in babies having planned surgery under general anesthesia. General anesthesia is a medicine that keeps patients asleep during surgery.
The main questions this study aims to answer are: Does the distance between the skin and the epidural space change with a baby's age, weight, height, or gestational age? Are the measurements similar when ultrasound images are taken from different directions? How close are the ultrasound measurements to the actual depth reached by the needle in babies who receive epidural pain treatment as part of their regular medical care?
Read more
Participants will have ultrasound images taken after they are asleep under general anesthesia. Measurements will be taken at 4 different areas of the lower back and from 2 different viewing directions. The measurements will be performed by 2 experienced doctors. Each doctor will repeat the same measurements 2 times to check consistency. Participants will receive epidural pain treatment only if it is already planned as part of their usual care.
No extra invasive procedure or additional medication will be given for this study.
Read the detailed description
Epidural analgesia is an effective method for perioperative pain management in pediatric patients and is widely used to reduce postoperative pain and opioid requirements. In infants, however, epidural procedures may be technically challenging because spinal anatomical structures are smaller and continue to change during early development. Variability in vertebral anatomy, ligament thickness, and spinal cord termination level may increase the difficulty of predicting epidural depth during neuraxial procedures. Even small differences in needle depth may be clinically important in this age group.
Ultrasonography has become an increasingly important tool in pediatric regional anesthesia because it provides real-time visualization of spinal anatomy without radiation exposure or harmful effects on the body. Preprocedural ultrasonographic assessment may help identify anatomical landmarks and estimate epidural depth before needle insertion. Previous studies have demonstrated that ultrasound measurements may correlate with actual epidural needle depth in pediatric patients. However, available data regarding normative skin-to-epidural distance measurements in infants remain limited, particularly at different vertebral levels and with different ultrasound imaging planes.
In infants, identification of the epidural space using conventional loss-of-resistance techniques may be more difficult than in older children and adults because tissue resistance changes may be less distinct. In addition, spinal anatomy changes rapidly during infancy, and measurements obtained at one vertebral level may not reflect measurements at other levels. Evaluation of multiple vertebral levels and imaging planes may therefore provide more comprehensive anatomical information for pediatric epidural procedures.
This study is designed to evaluate ultrasonographic skin-to-epidural distance measurements at multiple lumbar and thoracolumbar vertebral levels in infants undergoing elective surgery under general anesthesia. Measurements will be obtained using two commonly used ultrasound imaging planes to better characterize epidural depth in this population. The study will also evaluate the relationship between ultrasonographic measurements and demographic characteristics such as age, body weight, height, and gestational age.
Ultrasonographic evaluations will be performed during routine perioperative preparation under general anesthesia without additional invasive intervention for study purposes. In participants who undergo epidural catheter placement as part of routine clinical management, ultrasonographic measurements will additionally be compared with clinically measured epidural needle depth. Findings from this study may contribute to the development of more reliable reference data for infant epidural procedures and may support safer and more individualized pediatric regional anesthesia practices.
- Being tested
- Ultrasonographic Assessment of Skin-to-Epidural Distance, Epidural Catheter Placement for Clinical Indications
- Keywords
- Infants, Epidural Distance, Pediatric Regional Anesthesia, Skin-to-Epidural Distance, Epidural Depth, Neuraxial Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonographic Assessment of Skin-to-Epidural DistanceDiagnostic test
Infants aged 0 to 12 months undergoing elective surgery under general anesthesia will undergo ultrasonographic assessment of the distance between the skin and the epidural space. Measurements will be performed in the lateral decubitus position using a high-frequency linear ultrasound transducer with minimal probe pressure to avoid soft tissue compression. The distance will be evaluated at the intervertebral levels between the twelfth thoracic vertebra and the first lumbar vertebra, the first and second lumbar vertebrae, the second and third lumbar vertebrae, and the third and fourth lumbar vertebrae. Measurements will be obtained using both the paramedian sagittal oblique and transverse median ultrasound views. Two experienced anesthesiologists will independently perform the measurements. The probe will be removed and repositioned before repeat measurements. No needle insertion or epidural catheter placement will be performed as part of this intervention.
Epidural Catheter Placement for Clinical IndicationsProcedure or surgery
A subgroup of infants requiring epidural analgesia as part of routine perioperative care will undergo epidural catheter placement. Epidural catheterization will not be performed for research purposes and will only be undertaken when clinically indicated. Following ultrasonographic assessment and induction of general anesthesia, infants will be positioned in the lateral decubitus position. Epidural catheter placement will be performed according to standard institutional practice. The epidural space will be identified using the loss-of-resistance technique at the vertebral level selected by the attending anesthesiologist, and the depth from the skin to the epidural space will be recorded. Catheter insertion, confirmation of placement, and analgesic management will follow routine clinical protocols. Data from these procedures will be used to compare actual epidural depth with ultrasonographic measurements. No additional invasive procedures will be performed for study purposes.
| Study group | Role | What they receive |
|---|---|---|
| Infants Ungergoing Elective Surgery | Infants aged 0-12 months undergoing elective surgery under general anesthesia who will undergo ultrasonographic skin-to-epidural distance measurements during routine perioperative care. Receives: Diagnostic Test: Ultrasonographic Assessment of Skin-to-Epidural Distance; Procedure: Epidural Catheter Placement for Clinical Indications |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasonographic Skin-to-Epidural Distance
Distance between the skin and the epidural space measured by ultrasonography at the intervertebral levels between the twelfth thoracic vertebra and the first lumbar vertebra, between the first and second lumbar vertebrae, between the second and third lumbar vertebrae, and between the third and fourth lumbar vertebrae in infants.
Measured: During perioperative ultrasonographic assessment immediately after induction of general anesthesia
Secondary outcomes (3)
Comparison of Parasagittal Oblique and Transverse Median Ultrasound Measurements
Comparison of skin-to-epidural distance measurements obtained in the paramedian sagittal oblique and transverse median ultrasound planes.
Measured: During perioperative ultrasonographic assessment immediately after induction of general anesthesia
Intraobserver and Interobserver Measurement Reliability
Assessment of consistency of repeated ultrasonographic skin-to-epidural distance measurements performed by experienced anesthesiologists.
Measured: During perioperative ultrasonographic assessment immediately after induction of general anesthesia
Agreement Between Ultrasonographic Measurements and Epidural Needle Depth
Agreement between ultrasonographically measured skin-to-epidural distance and clinically measured epidural needle depth in participants undergoing epidural analgesia for routine clinical indications.
Measured: During epidural analgesia procedure performed as part of routine perioperative care
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ultrasonographic Evaluation of Epidural Depth in InfantsStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bahar İnan, Istanbul University - Cerrahpasa
- Investigators
- Ayşe Çiğdem Tütüncü, MD, Professor, Study chair, Istanbul University Cerrahpasa- Cerrahpasa Medical FacultyPınar Kendigelen, MD, Professor, Study director, Istanbul University Cerrahpasa- Cerrahpasa Medical FacultyMünevver Kayhan, MD, Study chair, Istanbul University Cerrahpasa- Cerrahpasa Medical FacultyBahar İnan, MD, Principal investigator, Istanbul University Cerrahpasa- Cerrahpasa Medical Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07847762
- Sponsor's protocol ID
- 1626310
- Status last verified
- Sep 2026
- First submitted
- 23 Sep 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sharapi M, Mahfouz A, Philip K, Mektebi A, Albakri K. Conventional anatomical landmark versus preprocedural ultrasound for thoracic epidural analgesia: A systematic review and meta-analysis. J Perioper Pract. 2024 Oct;34(10):315-325. doi: 10.1177/17504589231181974. Epub 2023 Sep 13.
PubMed 37702201Shaikh F, Brzezinski J, Alexander S, Arzola C, Carvalho JC, Beyene J, Sung L. Ultrasound imaging for lumbar punctures and epidural catheterisations: systematic review and meta-analysis. BMJ. 2013 Mar 26;346:f1720. doi: 10.1136/bmj.f1720.
PubMed 23532866Perlas A, Chaparro LE, Chin KJ. Lumbar Neuraxial Ultrasound for Spinal and Epidural Anesthesia: A Systematic Review and Meta-Analysis. Reg Anesth Pain Med. 2016 Mar-Apr;41(2):251-60. doi: 10.1097/AAP.0000000000000184.
PubMed 25493689
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Skin-to-Epidural Distance With Ultrasonography at Different Vertebral Levels in Infants: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07847762
- Acronym / sponsor ID
- 1626310
- Keywords
- Infants, Epidural Distance, Pediatric Regional Anesthesia, Skin-to-Epidural Distance, Epidural Depth, Neuraxial Ultrasound
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 29 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to learn about the distance between the skin and the epidural space in infants younger than 12 months. The epidural space is an area near the spinal cord where doctors can give pain medicine to help control pain during and after surgery. Epidural pain treatment can greatly reduce the amount of pain a child feels after surgery. Researchers will use ultrasound, a method that uses sound waves to create images inside the body and does not have harmful effects on the body, to measure this distance in babies having planned surgery under general anesthesia. General anesthesia is a medicine that keeps patients asleep during surgery.
The main questions this study aims to answer are: Does the distance between the skin and the epidural space change with a baby's age, weight, height, or gestational age? Are the measurements similar when ultrasound images are taken from different directions? How close are the ultrasound measurements to the actual depth reached by the needle in babies who receive epidural pain treatment as part of their regular medical care?
Participants will have ultrasound images taken after they are asleep under general anesthesia. Measurements will be taken at 4 different areas of the lower back and from 2 different viewing directions. The measurements will be performed by 2 experienced doctors. Each doctor will repeat the same measurements 2 times to check consistency. Participants will receive epidural pain treatment only if it is already planned as part of their usual care.
No extra invasive procedure or additional medication will be given for this study.
Detailed description
Epidural analgesia is an effective method for perioperative pain management in pediatric patients and is widely used to reduce postoperative pain and opioid requirements. In infants, however, epidural procedures may be technically challenging because spinal anatomical structures are smaller and continue to change during early development. Variability in vertebral anatomy, ligament thickness, and spinal cord termination level may increase the difficulty of predicting epidural depth during neuraxial procedures. Even small differences in needle depth may be clinically important in this age group.
Ultrasonography has become an increasingly important tool in pediatric regional anesthesia because it provides real-time visualization of spinal anatomy without radiation exposure or harmful effects on the body. Preprocedural ultrasonographic assessment may help identify anatomical landmarks and estimate epidural depth before needle insertion. Previous studies have demonstrated that ultrasound measurements may correlate with actual epidural needle depth in pediatric patients. However, available data regarding normative skin-to-epidural distance measurements in infants remain limited, particularly at different vertebral levels and with different ultrasound imaging planes.
In infants, identification of the epidural space using conventional loss-of-resistance techniques may be more difficult than in older children and adults because tissue resistance changes may be less distinct. In addition, spinal anatomy changes rapidly during infancy, and measurements obtained at one vertebral level may not reflect measurements at other levels. Evaluation of multiple vertebral levels and imaging planes may therefore provide more comprehensive anatomical information for pediatric epidural procedures.
This study is designed to evaluate ultrasonographic skin-to-epidural distance measurements at multiple lumbar and thoracolumbar vertebral levels in infants undergoing elective surgery under general anesthesia. Measurements will be obtained using two commonly used ultrasound imaging planes to better characterize epidural depth in this population. The study will also evaluate the relationship between ultrasonographic measurements and demographic characteristics such as age, body weight, height, and gestational age.
Ultrasonographic evaluations will be performed during routine perioperative preparation under general anesthesia without additional invasive intervention for study purposes. In participants who undergo epidural catheter placement as part of routine clinical management, ultrasonographic measurements will additionally be compared with clinically measured epidural needle depth. Findings from this study may contribute to the development of more reliable reference data for infant epidural procedures and may support safer and more individualized pediatric regional anesthesia practices.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infants Ungergoing Elective Surgery | – | Diagnostic Test: Ultrasonographic Assessment of Skin-to-Epidural Distance, Procedure: Epidural Catheter Placement for Clinical IndicationsInfants aged 0-12 months undergoing elective surgery under general anesthesia who will undergo ultrasonographic skin-to-epidural distance measurements during routine perioperative care. |
Who may qualify
- Ages
- Up to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Participants will be recruited from infants scheduled for elective surgical procedures at the operating rooms of the Department of Anesthesiology and Reanimation, Cerrahpaşa Faculty of Medicine, Istanbul University-Cerrahpaşa. The study population consists of infants undergoing routine perioperative evaluation under general anesthesia in a tertiary academic medical center.
Key inclusion criteria (4 listed)
- Infants aged 0 to 12 months
- Scheduled for elective surgery under general anesthesia
- American Society of Anesthesiologists physical status I to III
- Written informed consent obtained from parents or legal guardians
Key exclusion criteria (8 listed)
- Known vertebral or spinal cord anomalies, including scoliosis or spina bifida
- Previous spinal surgery
- Neuromuscular disease or known spinal cord pathology
- Congenital syndromes associated with systemic malformations
- Severe pulmonary, cardiac, hemodynamic, or neurological instability
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 |
|---|---|---|
| Ultrasonographic Assessment of Skin-to-Epidural DistanceInfants aged 0 to 12 months undergoing elective surgery under general anesthesia will undergo ultrasonographic assessment of the distance between the skin and the epidural space. Measurements will be performed in the lateral decubitus position using a high-frequency linear ultrasound transducer with minimal probe pressure to avoid soft tissue compression. The distance will be evaluated at the intervertebral levels between the twelfth thoracic vertebra and the first lumbar vertebra, the first and second lumbar vertebrae, the second and third lumbar vertebrae, and the third and fourth lumbar vertebrae. Measurements will be obtained using both the paramedian sagittal oblique and transverse median ultrasound views. Two experienced anesthesiologists will independently perform the measurements. The probe will be removed and repositioned before repeat measurements. No needle insertion or epidural catheter placement will be performed as part of this intervention. | Diagnostic test | Infants Ungergoing Elective Surgery |
| Epidural Catheter Placement for Clinical IndicationsA subgroup of infants requiring epidural analgesia as part of routine perioperative care will undergo epidural catheter placement. Epidural catheterization will not be performed for research purposes and will only be undertaken when clinically indicated. Following ultrasonographic assessment and induction of general anesthesia, infants will be positioned in the lateral decubitus position. Epidural catheter placement will be performed according to standard institutional practice. The epidural space will be identified using the loss-of-resistance technique at the vertebral level selected by the attending anesthesiologist, and the depth from the skin to the epidural space will be recorded. Catheter insertion, confirmation of placement, and analgesic management will follow routine clinical protocols. Data from these procedures will be used to compare actual epidural depth with ultrasonographic measurements. No additional invasive procedures will be performed for study purposes. | Procedure or surgery | Infants Ungergoing Elective Surgery |
Primary outcome
Ultrasonographic Skin-to-Epidural Distance
Time frame: During perioperative ultrasonographic assessment immediately after induction of general anesthesia
Distance between the skin and the epidural space measured by ultrasonography at the intervertebral levels between the twelfth thoracic vertebra and the first lumbar vertebra, between the first and second lumbar vertebrae, between the second and third lumbar vertebrae, and between the third and fourth lumbar vertebrae in infants.
3 secondary outcomes
Comparison of Parasagittal Oblique and Transverse Median Ultrasound Measurements
Time frame: During perioperative ultrasonographic assessment immediately after induction of general anesthesia
Intraobserver and Interobserver Measurement Reliability
Time frame: During perioperative ultrasonographic assessment immediately after induction of general anesthesia
Agreement Between Ultrasonographic Measurements and Epidural Needle Depth
Time frame: During epidural analgesia procedure performed as part of routine perioperative care
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Background: PubMed 37702201Sharapi M, Mahfouz A, Philip K, Mektebi A, Albakri K. Conventional anatomical landmark versus preprocedural ultrasound for thoracic epidural analgesia: A systematic review and meta-analysis. J Perioper Pract. 2024 Oct;34(10):315-325. doi: 10.1177/17504589231181974. Epub 2023 Sep 13.
- Background: PubMed 23532866Shaikh F, Brzezinski J, Alexander S, Arzola C, Carvalho JC, Beyene J, Sung L. Ultrasound imaging for lumbar punctures and epidural catheterisations: systematic review and meta-analysis. BMJ. 2013 Mar 26;346:f1720. doi: 10.1136/bmj.f1720.
- Background: PubMed 25493689Perlas A, Chaparro LE, Chin KJ. Lumbar Neuraxial Ultrasound for Spinal and Epidural Anesthesia: A Systematic Review and Meta-Analysis. Reg Anesth Pain Med. 2016 Mar-Apr;41(2):251-60. doi: 10.1097/AAP.0000000000000184.
- 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.
Ayşe Çiğdem Tütüncü, MD, Professor study chair
Istanbul University Cerrahpasa- Cerrahpasa Medical Faculty
Pınar Kendigelen, MD, Professor study director
Istanbul University Cerrahpasa- Cerrahpasa Medical Faculty
Münevver Kayhan, MD study chair
Istanbul University Cerrahpasa- Cerrahpasa Medical Faculty
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 Ultrasonographic Evaluation of Epidural Depth in Infants, run by Istanbul University - Cerrahpasa 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 4 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: opening soon, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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?
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 Bahar Inan, MD (+905387352525, bahar.inan@iuc.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ultrasonographic Skin-to-Epidural Distance (time frame: During perioperative ultrasonographic assessment immediately after induction of general anesthesia). 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 NCT07847762, which also lists 3 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 29 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.