Central Venous Catheter PlacementNCT04256564
Comparison of Two Syringe-free In-plane Techniques in Ultrasound-guided Central Venous Catheterization
A study testing Central venous catheterization in people with Central Venous Catheter Placement, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
Ultrasound guidance has become a standard for central venous catheterization. The aim of this study is to compare jugular venous catheterization by using lateral oblique approach to brachiocephalic catheterization by using Y-shape imaging. The trial is planned as prospective randomized and single-blind study. Read more about this study
- Who is it for?
- Ages 19 to 85 years
- Conditions the study is for
- Central Venous Catheter Placement
- What is being tested?
- Central venous catheterization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Mar 2020to Jul 2020
- 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 19 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients that are planned a central venous catheter placement
Who cannot join
- Morbid obese patients (body mass index> 40)
- People with severe coagulopathy
- Severe deformity at the neck
- Skin deformity or infection at catheterization site
- Congenital anomalies of central veins
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Kutahya Health Sciences University, Evliya CelebiHospital
Kütahya, 43040
Tayfun Aydın, MD., +90 274 231 6660 ext. 2040, drtayfunaydin@gmail.com
Miray K Turgut, MD.
About this study
Official title: Comparison of Two Syringe-free In-plane Techniques in Ultrasound-guided Central Venous Catheterization: Jugular Venous Catheterization With Oblique Approach and Brachiocephalic Catheterization Using Y-shape Image
Ultrasound guidance has become a standard for central venous catheterization. The aim of this study is to compare jugular venous catheterization by using lateral oblique approach to brachiocephalic catheterization by using Y-shape imaging. The trial is planned as prospective randomized and single-blind study. Eighty patients are planned to include in this study. Patients will be assigned to two groups: Oblique visualization Group (central catheter will be placed to the jugular vein by using ultrasound-guided in-plane syringe-free technique) and Y-shape visualization Group (central catheter will be placed to the brachiocephalic vein by using ultrasound-guided in-plane syringe-free technique). Two groups will be compared in terms of number of puncture attempts, procedural time, time of preprocedural ultrasound scanning, overall success rate, complications, the ease of the catheterization process and ultrasound visibility.
Read the detailed description
Central venous catheters are frequently placed in the operating rooms, intensive care units and emergency departments for various indications such as intravenous fluid, drug infusion, measurement of cardiac parameters and lack of vascular access. Ultrasound guidance has become a standard for central venous catheterization. The use of ultrasound has reduced the number of puncture attempts, increased success rate and reduced complications. While the central venous catheter is inserted by ultrasound, the vessels and the needle can be imaged in real-time. In plane and out-of-plane imaging techniques can be used during catheterization. The in-plane technique ensures the entire needle visualization in ultrasound images. With the linear ultrasound probe, the vessel and needle are imaged longitudinally in the in-plane technique. When an endocavity (micro-convex) ultrasound probe is used, three central vessels (jugular, subclavian and brachiocephalic veins) are displayed as Y-shape. The advantage of the endocavity (micro-convex) probe is that it can visualize deeper tissues and deep veins, and more tissues can be imaged in wider angle. Both techniques have been successfully applied in central catheter placement. In-plane technique also ensures syringe-free cannulation where blood aspiration with a syringe attached to the needle is not necessary.
The aim of this study is to compare two different ultrasound guided in-plane techniques for central venous catheterization. The investigators planned to compare jugular venous catheterization using a linear probe and lateral oblique approach to brachiocephalic catheterization using a micro-convex probe and Y-shape imaging.
The primary outcomes are number of puncture attempts, success rate at first attempt, overall success rate, procedure time, ultrasound scanning time and rate of complications. Secondary outcomes are visibility of the veins and the needle in ultrasound images.
The trial is a comparison of two different interventional technique and planned as prospective randomized and single-blind study. Patients aged between 18-85 years that are planned central venous catheter placement will be included in the study. Patients included in the study will be assigned into two groups by computer-assisted randomization. In the first group (Oblique visualization Group), central catheter will be placed to the jugular vein by using ultrasound-guided in-plane syringe-free technique. In the second group (Y-shape visualization Group), central catheter will be placed to the brachiocephalic vein by using ultrasound-guided in-plane syringe-free technique Linear ultrasound probe will be used in the first group, and endocavity (micro-convex) ultrasound probe will be used in the second group.
In both groups, the number of puncture attempts, the number of needle redirections, and the procedure time will be recorded. The time of preprocedural ultrasound scanning will be recorded in both groups. In addition, complications during the procedure such as bleeding, hemothorax, pneumothorax, hematoma and carotid vascular injury will be recorded. Overall success rates will be assessed in each group at the end of the study. A catheterization procedure will be considered as "unsuccessful" after third puncture attempt or more than 10 needle redirections are needed or requires a procedure time more than 3 minutes. At this moment, the catheter will be placed to a different region or the investigators will switch to a different approach. The ease of the catheterization process will be scored between 0 and 10 by the investigator performing the process (0: the hardest, 10: the easiest). The ultrasound visibility of the needle, vessels, guide wire and catheter will be scored between 0 and 4 (4: excellent view, 3: good view, 2: Medium, 1: difficult 0: impossible to image). The recorded data will be compared between the two groups.
- Conditions
- Central Venous Catheter Placement
- Being tested
- Central venous catheterization
- Keywords
- Central venous catheter, Ultrasound, Jugular vein, Brachiocephalic vein, Endocavity micro-convex probe, Y-Shape
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Central venous catheterizationProcedure or surgery
A standard 20 cm (adult-size) 3-port central catheter will be placed to the indicated patients by using standard Seldinger technique (with the assist of a guide wire) under ultrasound guidance
| Study group | Role | What they receive |
|---|---|---|
| Oblique visualization linear probe | Experimental | A linear ultrasound probe will be utilized to place the central catheter into the jugular vein Receives: Procedure: Central venous catheterization |
| Y-shape visualization micro-convex probe | Experimental | A micro-convex endocavity ultrasound probe will be utilized to place the central catheter into the brachiocephalic vein Receives: Procedure: Central venous catheterization |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of puncture attempts
Number of needle insertions to the catheterization region for placing a catheter
Measured: During the whole cannulation procedure, starting from the 1st minute until the end of the procedure
Cannulation procedural time
Duration of the whole cannulation procedure
Measured: From the 1st minute through withdrawal of the needle, up to 3 minutes
Catheterization procedural time
Duration of the whole catheterization procedure
Measured: During the procedure, starting from the 1st minute through placement of the catheter; up to 3 minutes
Number of needle redirections
Redirections of the needle towards the vessel
Measured: During the whole cannulation procedure, starting from the 1st minute through the procedure; assessed up to 3 minutes
Success rate
Overall success rates of the procedures in each group
Measured: Through study completion, an average of 4 months
Success rate at first attempt
Success rate at first attempt of the procedures in each group
Measured: Through study completion, an average of 4 months
Complications
Rate of complications that occur during catheterization procedure
Measured: Through study completion, an average of 4 months
Secondary outcomes (6)
Vessel visualization
Visualization of the vessels in dynamic ultrasound images
Measured: Throughout the procedure; up to 3 minutes
Needle visualization
Visualization of the needle in dynamic ultrasound images
Measured: Throughout the procedure; up to 3 minutes
Guide-wire visualization
Visualization of the guide-wire in dynamic ultrasound images
Measured: Throughout the procedure; up to 3 minutes
Catheter visualization
Visualization of the catheter in dynamic ultrasound images
Measured: At the end of catheterization procedure
Ease of the catheterization process
A subjective score assigned by the operator on a scale with a minimum value of 0 and maximum value of 10. Higher scores mean a better outcome.
Measured: Throughout the procedure; up to 3 minutes
Ultrasound time
The duration of pre-procedural ultrasound scanning
Measured: Throughout the pre-procedural ultrasonography; up to 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study startMar 2020 (estimated)
- Primary completionJun 2020 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Central Venous Catheter PlacementStudies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There will be two parallel groups in each a different central catheterization method will be performed.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Onur Balaban, MD, Kutahya Health Sciences University
- Investigators
- Onur Balaban, MD., Principal investigator, Kutahya Health Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04256564
- Sponsor's protocol ID
- 2019/06OBLVSYSHAPE
- Status last verified
- Feb 2020
- First submitted
- 14 Jan 2020
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Schmidt GA, Maizel J, Slama M. Ultrasound-guided central venous access: what's new? Intensive Care Med. 2015 Apr;41(4):705-7. doi: 10.1007/s00134-014-3628-6. Epub 2015 Jan 8. No abstract available.
PubMed 25567384Baidya DK, Chandralekha, Darlong V, Pandey R, Goswami D, Maitra S. Comparative Sonoanatomy of Classic "Short Axis" Probe Position with a Novel "Medial-oblique" Probe Position for Ultrasound-guided Internal Jugular Vein Cannulation: A Crossover Study. J Emerg Med. 2015 May;48(5):590-6. doi: 10.1016/j.jemermed.2014.07.062. Epub 2015 Jan 24.
PubMed 25630474Mallin M, Louis H, Madsen T. A novel technique for ultrasound-guided supraclavicular subclavian cannulation. Am J Emerg Med. 2010 Oct;28(8):966-9. doi: 10.1016/j.ajem.2009.07.019. Epub 2010 Jan 28.
PubMed 20887917Ital I, Balaban O, Aydin T. Old probe, new method: Y-shape visualization of central veins using endocavitary transducer via omoclavicular acoustic window. Am J Emerg Med. 2018 Mar;36(3):511-513. doi: 10.1016/j.ajem.2017.07.096. Epub 2017 Jul 31. No abstract available.
PubMed 28789889Kim SC, Heinze I, Schmiedel A, Baumgarten G, Knuefermann P, Hoeft A, Weber S. Ultrasound confirmation of central venous catheter position via a right supraclavicular fossa view using a microconvex probe: an observational pilot study. Eur J Anaesthesiol. 2015 Jan;32(1):29-36. doi: 10.1097/EJA.0000000000000042.
PubMed 24384583Matias F, Semedo E, Carreira C, Pereira P. [Ultrasound-guided central venous catheterization - "Syringe-Free" approach]. Rev Bras Anestesiol. 2017 May-Jun;67(3):314-317. doi: 10.1016/j.bjan.2016.08.005. Epub 2016 Sep 17. Portuguese.
PubMed 27650385Ince I, Ari MA, Sulak MM, Aksoy M. [Comparison of transverse short-axis classic and oblique long-axis "Syringe-Free" approaches for internal jugular venous catheterization under ultrasound guidance]. Braz J Anesthesiol. 2018 May-Jun;68(3):260-265. doi: 10.1016/j.bjan.2017.12.002. Epub 2018 Feb 23.
PubMed 29478705
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Syringe-free In-plane Techniques in Ultrasound-guided Central Venous Catheterization: Jugular Venous Catheterization With Oblique Approach and Brachiocephalic Catheterization Using Y-shape Image
- ClinicalTrials.gov ID
- NCT04256564
- Acronym / sponsor ID
- 2019/06OBLVSYSHAPE
- Conditions
- Central Venous Catheter Placement
- Keywords
- Central venous catheter, Ultrasound, Jugular vein, Brachiocephalic vein, Endocavity micro-convex probe, Y-Shape
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- Mar 2020 (estimated)
- Primary completion
- Jun 2020 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 5 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.
Ultrasound guidance has become a standard for central venous catheterization. The aim of this study is to compare jugular venous catheterization by using lateral oblique approach to brachiocephalic catheterization by using Y-shape imaging. The trial is planned as prospective randomized and single-blind study. Eighty patients are planned to include in this study. Patients will be assigned to two groups: Oblique visualization Group (central catheter will be placed to the jugular vein by using ultrasound-guided in-plane syringe-free technique) and Y-shape visualization Group (central catheter will be placed to the brachiocephalic vein by using ultrasound-guided in-plane syringe-free technique). Two groups will be compared in terms of number of puncture attempts, procedural time, time of preprocedural ultrasound scanning, overall success rate, complications, the ease of the catheterization process and ultrasound visibility.
Detailed description
Central venous catheters are frequently placed in the operating rooms, intensive care units and emergency departments for various indications such as intravenous fluid, drug infusion, measurement of cardiac parameters and lack of vascular access. Ultrasound guidance has become a standard for central venous catheterization. The use of ultrasound has reduced the number of puncture attempts, increased success rate and reduced complications. While the central venous catheter is inserted by ultrasound, the vessels and the needle can be imaged in real-time. In plane and out-of-plane imaging techniques can be used during catheterization. The in-plane technique ensures the entire needle visualization in ultrasound images. With the linear ultrasound probe, the vessel and needle are imaged longitudinally in the in-plane technique. When an endocavity (micro-convex) ultrasound probe is used, three central vessels (jugular, subclavian and brachiocephalic veins) are displayed as Y-shape. The advantage of the endocavity (micro-convex) probe is that it can visualize deeper tissues and deep veins, and more tissues can be imaged in wider angle. Both techniques have been successfully applied in central catheter placement. In-plane technique also ensures syringe-free cannulation where blood aspiration with a syringe attached to the needle is not necessary.
The aim of this study is to compare two different ultrasound guided in-plane techniques for central venous catheterization. The investigators planned to compare jugular venous catheterization using a linear probe and lateral oblique approach to brachiocephalic catheterization using a micro-convex probe and Y-shape imaging.
The primary outcomes are number of puncture attempts, success rate at first attempt, overall success rate, procedure time, ultrasound scanning time and rate of complications. Secondary outcomes are visibility of the veins and the needle in ultrasound images.
The trial is a comparison of two different interventional technique and planned as prospective randomized and single-blind study. Patients aged between 18-85 years that are planned central venous catheter placement will be included in the study. Patients included in the study will be assigned into two groups by computer-assisted randomization. In the first group (Oblique visualization Group), central catheter will be placed to the jugular vein by using ultrasound-guided in-plane syringe-free technique. In the second group (Y-shape visualization Group), central catheter will be placed to the brachiocephalic vein by using ultrasound-guided in-plane syringe-free technique Linear ultrasound probe will be used in the first group, and endocavity (micro-convex) ultrasound probe will be used in the second group.
In both groups, the number of puncture attempts, the number of needle redirections, and the procedure time will be recorded. The time of preprocedural ultrasound scanning will be recorded in both groups. In addition, complications during the procedure such as bleeding, hemothorax, pneumothorax, hematoma and carotid vascular injury will be recorded. Overall success rates will be assessed in each group at the end of the study. A catheterization procedure will be considered as "unsuccessful" after third puncture attempt or more than 10 needle redirections are needed or requires a procedure time more than 3 minutes. At this moment, the catheter will be placed to a different region or the investigators will switch to a different approach. The ease of the catheterization process will be scored between 0 and 10 by the investigator performing the process (0: the hardest, 10: the easiest). The ultrasound visibility of the needle, vessels, guide wire and catheter will be scored between 0 and 4 (4: excellent view, 3: good view, 2: Medium, 1: difficult 0: impossible to image). The recorded data will be compared between the two groups.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- There will be two parallel groups in each a different central catheterization method will be performed.
| Arm | Type | Receives |
|---|---|---|
| Oblique visualization linear probe | Experimental | Procedure: Central venous catheterizationA linear ultrasound probe will be utilized to place the central catheter into the jugular vein |
| Y-shape visualization micro-convex probe | Experimental | Procedure: Central venous catheterizationA micro-convex endocavity ultrasound probe will be utilized to place the central catheter into the brachiocephalic vein |
Who may qualify
- Ages
- 19 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients that are planned a central venous catheter placement
Key exclusion criteria (5 listed)
- Morbid obese patients (body mass index> 40)
- People with severe coagulopathy
- Severe deformity at the neck
- Skin deformity or infection at catheterization site
- Congenital anomalies of central veins
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 |
|---|---|---|
| Central venous catheterizationA standard 20 cm (adult-size) 3-port central catheter will be placed to the indicated patients by using standard Seldinger technique (with the assist of a guide wire) under ultrasound guidance | Procedure or surgery | Oblique visualization linear probe, Y-shape visualization micro-convex probe |
Primary outcome
Number of puncture attempts
Time frame: During the whole cannulation procedure, starting from the 1st minute until the end of the procedure
Number of needle insertions to the catheterization region for placing a catheter
Cannulation procedural time
Time frame: From the 1st minute through withdrawal of the needle, up to 3 minutes
Duration of the whole cannulation procedure
Catheterization procedural time
Time frame: During the procedure, starting from the 1st minute through placement of the catheter; up to 3 minutes
Duration of the whole catheterization procedure
Number of needle redirections
Time frame: During the whole cannulation procedure, starting from the 1st minute through the procedure; assessed up to 3 minutes
Redirections of the needle towards the vessel
Success rate
Time frame: Through study completion, an average of 4 months
Overall success rates of the procedures in each group
Success rate at first attempt
Time frame: Through study completion, an average of 4 months
Success rate at first attempt of the procedures in each group
Complications
Time frame: Through study completion, an average of 4 months
Rate of complications that occur during catheterization procedure
6 secondary outcomes
Vessel visualization
Time frame: Throughout the procedure; up to 3 minutes
Needle visualization
Time frame: Throughout the procedure; up to 3 minutes
Guide-wire visualization
Time frame: Throughout the procedure; up to 3 minutes
Catheter visualization
Time frame: At the end of catheterization procedure
Ease of the catheterization process
Time frame: Throughout the procedure; up to 3 minutes
Ultrasound time
Time frame: Throughout the pre-procedural ultrasonography; up to 10 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2020.
- Background: PubMed 25567384Schmidt GA, Maizel J, Slama M. Ultrasound-guided central venous access: what's new? Intensive Care Med. 2015 Apr;41(4):705-7. doi: 10.1007/s00134-014-3628-6. Epub 2015 Jan 8. No abstract available.
- Background: PubMed 25630474Baidya DK, Chandralekha, Darlong V, Pandey R, Goswami D, Maitra S. Comparative Sonoanatomy of Classic "Short Axis" Probe Position with a Novel "Medial-oblique" Probe Position for Ultrasound-guided Internal Jugular Vein Cannulation: A Crossover Study. J Emerg Med. 2015 May;48(5):590-6. doi: 10.1016/j.jemermed.2014.07.062. Epub 2015 Jan 24.
- Background: PubMed 20887917Mallin M, Louis H, Madsen T. A novel technique for ultrasound-guided supraclavicular subclavian cannulation. Am J Emerg Med. 2010 Oct;28(8):966-9. doi: 10.1016/j.ajem.2009.07.019. Epub 2010 Jan 28.
- Background: PubMed 28789889Ital I, Balaban O, Aydin T. Old probe, new method: Y-shape visualization of central veins using endocavitary transducer via omoclavicular acoustic window. Am J Emerg Med. 2018 Mar;36(3):511-513. doi: 10.1016/j.ajem.2017.07.096. Epub 2017 Jul 31. No abstract available.
- Background: PubMed 24384583Kim SC, Heinze I, Schmiedel A, Baumgarten G, Knuefermann P, Hoeft A, Weber S. Ultrasound confirmation of central venous catheter position via a right supraclavicular fossa view using a microconvex probe: an observational pilot study. Eur J Anaesthesiol. 2015 Jan;32(1):29-36. doi: 10.1097/EJA.0000000000000042.
- Background: PubMed 27650385Matias F, Semedo E, Carreira C, Pereira P. [Ultrasound-guided central venous catheterization - "Syringe-Free" approach]. Rev Bras Anestesiol. 2017 May-Jun;67(3):314-317. doi: 10.1016/j.bjan.2016.08.005. Epub 2016 Sep 17. Portuguese.
- Background: PubMed 29478705Ince I, Ari MA, Sulak MM, Aksoy M. [Comparison of transverse short-axis classic and oblique long-axis "Syringe-Free" approaches for internal jugular venous catheterization under ultrasound guidance]. Braz J Anesthesiol. 2018 May-Jun;68(3):260-265. doi: 10.1016/j.bjan.2017.12.002. Epub 2018 Feb 23.
- 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.
Onur Balaban, MD. principal investigator
Kutahya Health Sciences 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 Central venous catheterization in people with Central Venous Catheter Placement, run by Kutahya Health Sciences 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 1 inclusion and 5 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 5 Feb 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Onur Balaban, MD.. (+90 274 231 6660, obalabandr@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of puncture attempts (time frame: During the whole cannulation procedure, starting from the 1st minute until the end of the procedure). The study lists 7 primary outcomes in all. 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 NCT04256564, which also lists 7 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 5 Feb 2020.