Anesthesia, ConductionNCT03741465

A New Neuraxial Position Technique " The Anatolian Sitting Position- Sitting Fetal Cross-legged"

A study testing The SFP technique and The ASP technique in people with Anesthesia, Conduction, run by Yeditepe University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

A prosperous neuraxial anesthesia positioning ensures a raised chance of successful needle placement. The primary aim is to compare "The Anatolian sitting position-ASP" with "The Sitting Fetal Position-SFP" sonographically. Secondary aim is to compare their comfort. Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Anesthesia, Conduction
What is being tested?: The SFP technique and The ASP technique
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 1 Jun 2018to 20 Sep 2018
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 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

healty and adult volunteers,
must be able to do the sitting fetal cross-legged position ( ASP ),
must be able to do the sitting fetal position ( SFP ).

Who cannot join

BMI higher than 40,
Lumbar hernia,
Scoliosis,
History of spine surgery,
History of trauma,
History of lower back pain,
Arthropathy {especially pelvic or knee problems},
Could not be able to do one or both of the two neuraxial position techniques.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Yeditepe University hospital
Istanbul, İçerenköy

Other trials in Turkey (Türkiye)

About this study

Official title: "The Anatolian Sitting Neuraxial Position Technique"; is it Beneficial? A Prospective Clinical Comparison Trial Via Ultrasonography

Read the detailed description

Fifty participants were included to this prospective, randomized, consecutive controlled clinical study. Six parameters were evaluated in each position; subcutaneous tissue (ST), skin to spinous process (S-SP), transverse diameters of bilateral paraspinal muscles (left paraspinal muscle [LPM] and right paraspinal muscle [RPM]), interspinous gap opening (ISGO), mean of bilateral paraspinal muscles (MPM). The change of every measurement recorded via ultrasonography (USG) according to the positioning techniques (the Anatolian Sitting Position [ASP] could also be named as "sitting fetal cross-legged position" and the Sitting Fetal Position [SFP] which is a traditional sitting position) were also calculated. The calculations are explained briefly in primary outcomes (including the change of ASP-SFP in ST, S-SP, LPM, RPM, MPM, ISGO). Stretcher comfort (SC), position comfort (PC), lumbar comfort (LC), and abdominal comfort (AC) were evaluated by the participants with the 5-point Numerical Rating Scale (NRS).

Conditions: Anesthesia, Conduction
Being tested: The SFP technique, The ASP technique
Keywords: neuraxial anesthesia positioning technique, Anatolian sitting position, sitting cross-legged position, sitting fetal position, ultrasonography, numerical rating scale

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

The SFP techniqueProcedure or surgery
The USG, and the 5-point NRS evaluation in the SFP
The ASP techniqueProcedure or surgery
The USG, and the 5-point NRS evaluation in the ASP

Study groups in NCT03741465
Study group	Role	What they receive
The SFP technique	Active comparator	In the SFP neuraxial positioning technique, fifty participants were planned to sit on the stretcher facing the wall of the sonography room and turned back to the consultant Radiologist with legs hanging freely, forearms on the lap and hand are on the knees. The position is completed with the back curved in the fetal position. Then the USG is performed by the consultant Radiology M.D. in maximum 2 hours time to each participant, and the 5-point NRS evaluation is done by each participant in maximum 30 minutes time until the study ends within 24 weeks. Receives: Procedure: The SFP technique
The ASP technique	Experimental	In the ASP neuraxial positioning technique, the same fifty participants were planned to sit on the same part of the stretcher facing the wall of the sonography room and turned back to the consultant Radiologist with legs crossed, forearms of the participants are on the lap and hands are on the knees, and the position is completed with the back curved in the fetal position.Then the USG is performed by the consultant Radiology M.D. in maximum 2 hours time to each participant, and the 5-point NRS evaluation is done by each participant in maximum 30 minutes time until the study ends within 24 weeks. Receives: Procedure: The ASP technique

What is being measured

The primary outcome is the main question the study is designed to answer.

Interspinous gap opening (ISGO) measurement in the ASP
the wideness measurement of the ISGO in millimeters via ultrasonography (USG) in the ASP
Measured: For the ASP technique, ISGO is measured in the first 10 minutes(mins.) time, for each participant, through study completion.
Left paraspinal muscle (LPM) measurements in the ASP
the diameter measurement of the LPM in millimeters via ultrasonography in the ASP
Measured: For the ASP technique, LPM is measured in between 10mins. and 20mins. time, for each participant, through study completion.
Right paraspinal muscle (RPM) measurements in the ASP
the diameter measurement of the RPM in millimeters via ultrasonography in the ASP
Measured: For the ASP technique, RPM is measured in between 20mins. and 30mins. time, for each participant, through study completion.
The mean of bilateral paraspinal muscles (MPM) in the ASP
Measured by ( [LPM+RPM]/2) in millimeters in the ASP
Measured: For the ASP technique, MPM measurement is planned to be done in between 30mins. and 40mins. time, for each participant, through study completion.
Subcutaneous tissue (ST) measurements in the ASP
the thickness measurement of the subcutaneous tissue in millimeters via ultrasonography in the ASP
Measured: For the ASP technique, ST measurement is planned to be done in between 40mins. and 50mins. time, for each participant, through study completion.
The skin to spinous process (S-SP) measurements in the ASP
the depth measurement of the skin to spinous process in millimeters via ultrasonography in the ASP
Measured: For the ASP technique, S-SP measurement is planned to be done in between 50mins. and 1 hour(hr.) time, for each participant, through study completion.
Interspinous gap opening (ISGO) measurement in the SFP
the wideness measurement of the ISGO in millimeters via ultrasonography in the SFP
Measured: For the SFP technique, ISGO measurement is planned to be done, right after NRS evaluation of the ASP, in between 1hr.10mins. and 1hr.20mins. time, for each participant, through study completion.
Left paraspinal muscle (LPM) measurements in the SFP
the diameter measurement of the LPM in millimeters via ultrasonography in the SFP
Measured: For the SFP technique, LPM measurement is planned to be done in between 1hr.20mins. and 1hr.30mins. time, for each participant, through study completion.
Right paraspinal muscle (RPM) measurements in the SFP
the diameter measurement of the RPM in millimeters via ultrasonography in the SFP
Measured: For the SFP technique, RPM measurement is planned to be done in between 1hr.30mins. and 1hr.40mins. time, for each participant, through study completion.
The mean of bilateral paraspinal muscles (MPM) in the SFP
Measured by ( [LPM+RPM]/2) in millimeters in the SFP
Measured: For the SFP technique, MPM measurement is planned to be done in between 1hr.40mins. and 1hr.50mins. time, for each participant, through study completion.
Subcutaneous tissue (ST) measurements in the SFP
the thickness measurement of the subcutaneous tissue in millimeters via ultrasonography in the SFP
Measured: For the SFP technique, ST measurement is planned to be done in between 1hr.50mins. and 2hrs. time, for each participant, through study completion.
The skin to spinous process (S-SP) measurements in the SFP
the depth measurement of the skin to spinous process in millimeters via ultrasonography in the SFP
Measured: For the SFP technique, S-SP measurement is planned to be done in between 2hrs. and 2hr.10mins. time, for each participant, through study completion.
the change of ISGO (ISGO ASP-SFP)
Measured by calculation; ([ISGO in the ASP in millimeters]-[ISGO in the SFP in millimeters])
Measured: ISGO in the ASP is measured in the first 10mins., and ISGO in the SFP is measured in between 1hr.10 mins. and 1hr.20mins. time, through study completion.
the change of LPM (LPM ASP-SFP)
Measured by calculation; ([LPM in ASP in millimeters]-[LPM in SFP in millimeters])
Measured: LPM in the ASP is measured in between 10mins. and 20mins. time, and LPM in the SFP is measured in between 1hr.20mins and 1hr.30mins. time, through study completion.
the change of RPM (RPM ASP-SFP)
Measured by calculation ([RPM in ASP in millimeters]-[RPM in SFP in millimeters])
Measured: RPM in the ASP is measured in between 20mins. and 30mins. time, and RPM in the SFP is measured in between 1hr.30mins. and 1hr.40mins. time, through study completion.
the change of MPM (MPM ASP-SFP)
Measured by calculation ([MPM in ASP in millimeters]-[MPM in SFP in millimeters])
Measured: MPM in the ASP is measured in between 30mins. and 40mins. time, and MPM in the SFP is measured in between 1hr.40mins and 1hr.50mins. time, through study completion.
the change of ST (ST ASP-SFP)
Measured by calculation ([ST in ASP in millimeters]-[ST in SFP in millimeters])
Measured: ST in the ASP is measured in between 40mins. and 50mins. time, and in the SFP is measured in between 1hr.50mins and 2hrs. time, through study completion.
the change of S-SP (S-SP ASP-SFP)
Measured by calculation ([S-SP in ASP in millimeters]-[S-SP in SFP in millimeters])
Measured: S-SP in the ASP is measured in between 50mins. and 1hr. time, and S-SP in the SFP is measured in between 2 hrs. and 2hrs.10mins. time, through study completion.

Secondary outcomes (2)

Comfort evaluation in the ASP via 5-point numerical rating scale (NRS)
Comfort evaluation of the ASP technique is planned to be done by the participant right after USG. The 5-point NRS includes 5 scale. The minimum scale is"1" means poor, "2" means fair, "3" means good, "4" means very good, and the maximum scale is "5" means excellent.
Measured: NRS measurement is planned to be done right after the ASP position in between 1hr. and 1hr.10mins. time, for each participant, through study completion.
Comfort evaluation in the SFP via 5-point numerical rating scale (NRS)
Comfort evaluation of the SFP technique is planned to be done by the participant right after USG. The 5-point NRS includes 5 scale. The minimum scale is"1" means poor, "2" means fair, "3" means good, "4" means very good, and the maximum scale is "5" means excellent.
Measured: NRS measurement is planned to be done right after the SFP position in between 2hrs.10mins. and 2hrs.20mins. time, for each participant, through study completion.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jun 201820 Sep 2018

First posted15 Nov 2018
Study start1 Jun 2018
Primary completion20 Sep 2018
Study completion20 Sep 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Anesthesia, ConductionStudies 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: Other
Allocation: Randomised
Intervention model: Sequential
Model description: Systematic randomization was made from 150 volunteers, and 50 participants were chosen. All 50 participants were planned to sit on the stretcher in both of the two positioning techniques sequentially (one after another). The two positioning techniques are 1) sitting fetal position-" the SFP" ( a traditional position ) and 2) sitting fetal cross-legged-" the ASP" ( a new position, named as " Anatolian sitting position"). The investigator was planned to record all of the participants' anatomical measurements in both of those positioning techniques evaluated via ultrasonography. After each position participants were planned to evaluate each positioning technique's comfort by 5-point numerical rating scale from minimum 1 meaning "poor" to maximum 5 meaning "excellent."
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03741465
Sponsor's protocol ID: YeditepeU
Status last verified: Nov 2018
First submitted: 26 Oct 2018
Last updated: 16 Nov 2018
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

Dimaculangan DP, Mazer JA, Maracaja-Neto LF. Sonographic evaluation of lumbar interlaminar space opening in a variety of patient body positions for optimal neuraxial anesthesia delivery. J Clin Anesth. 2016 Nov;34:159-65. doi: 10.1016/j.jclinane.2016.03.045. Epub 2016 May 6.
PubMed 27687365

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 16 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: "The Anatolian Sitting Neuraxial Position Technique"; is it Beneficial? A Prospective Clinical Comparison Trial Via Ultrasonography
ClinicalTrials.gov ID: NCT03741465
Acronym / sponsor ID: YeditepeU
Conditions: Anesthesia, Conduction
Keywords: neuraxial anesthesia positioning technique, Anatolian sitting position, sitting cross-legged position, sitting fetal position, ultrasonography, numerical rating scale
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: Yeditepe UniversityUniversity, hospital or other
Study start: 1 Jun 2018 (actual)
Primary completion: 20 Sep 2018 (actual)
Study completion: 20 Sep 2018 (actual)
First posted: 15 Nov 2018 (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.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Sequential
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model description: Systematic randomization was made from 150 volunteers, and 50 participants were chosen. All 50 participants were planned to sit on the stretcher in both of the two positioning techniques sequentially (one after another). The two positioning techniques are 1) sitting fetal position-" the SFP" ( a traditional position ) and 2) sitting fetal cross-legged-" the ASP" ( a new position, named as " Anatolian sitting position"). The investigator was planned to record all of the participants' anatomical measurements in both of those positioning techniques evaluated via ultrasonography. After each position participants were planned to evaluate each positioning technique's comfort by 5-point numerical rating scale from minimum 1 meaning "poor" to maximum 5 meaning "excellent."

Arm	Type	Receives
The SFP technique	Active comparator	Procedure: The SFP techniqueIn the SFP neuraxial positioning technique, fifty participants were planned to sit on the stretcher facing the wall of the sonography room and turned back to the consultant Radiologist with legs hanging freely, forearms on the lap and hand are on the knees. The position is completed with the back curved in the fetal position. Then the USG is performed by the consultant Radiology M.D. in maximum 2 hours time to each participant, and the 5-point NRS evaluation is done by each participant in maximum 30 minutes time until the study ends within 24 weeks.
The ASP technique	Experimental	Procedure: The ASP techniqueIn the ASP neuraxial positioning technique, the same fifty participants were planned to sit on the same part of the stretcher facing the wall of the sonography room and turned back to the consultant Radiologist with legs crossed, forearms of the participants are on the lap and hands are on the knees, and the position is completed with the back curved in the fetal position.Then the USG is performed by the consultant Radiology M.D. in maximum 2 hours time to each participant, and the 5-point NRS evaluation is done by each participant in maximum 30 minutes time until the study ends within 24 weeks.

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

healty and adult volunteers,
must be able to do the sitting fetal cross-legged position ( ASP ),
must be able to do the sitting fetal position ( SFP ).

Key exclusion criteria (8 listed)

BMI higher than 40,
Lumbar hernia,
Scoliosis,
History of spine surgery,
History of trauma,

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
The SFP techniqueThe USG, and the 5-point NRS evaluation in the SFP	Procedure or surgery	The SFP technique
The ASP techniqueThe USG, and the 5-point NRS evaluation in the ASP	Procedure or surgery	The ASP technique

Primary outcome

Interspinous gap opening (ISGO) measurement in the ASP
Time frame: For the ASP technique, ISGO is measured in the first 10 minutes(mins.) time, for each participant, through study completion.
the wideness measurement of the ISGO in millimeters via ultrasonography (USG) in the ASP
Left paraspinal muscle (LPM) measurements in the ASP
Time frame: For the ASP technique, LPM is measured in between 10mins. and 20mins. time, for each participant, through study completion.
the diameter measurement of the LPM in millimeters via ultrasonography in the ASP
Right paraspinal muscle (RPM) measurements in the ASP
Time frame: For the ASP technique, RPM is measured in between 20mins. and 30mins. time, for each participant, through study completion.
the diameter measurement of the RPM in millimeters via ultrasonography in the ASP
The mean of bilateral paraspinal muscles (MPM) in the ASP
Time frame: For the ASP technique, MPM measurement is planned to be done in between 30mins. and 40mins. time, for each participant, through study completion.
Measured by ( [LPM+RPM]/2) in millimeters in the ASP
Subcutaneous tissue (ST) measurements in the ASP
Time frame: For the ASP technique, ST measurement is planned to be done in between 40mins. and 50mins. time, for each participant, through study completion.
the thickness measurement of the subcutaneous tissue in millimeters via ultrasonography in the ASP
The skin to spinous process (S-SP) measurements in the ASP
Time frame: For the ASP technique, S-SP measurement is planned to be done in between 50mins. and 1 hour(hr.) time, for each participant, through study completion.
the depth measurement of the skin to spinous process in millimeters via ultrasonography in the ASP
Interspinous gap opening (ISGO) measurement in the SFP
Time frame: For the SFP technique, ISGO measurement is planned to be done, right after NRS evaluation of the ASP, in between 1hr.10mins. and 1hr.20mins. time, for each participant, through study completion.
the wideness measurement of the ISGO in millimeters via ultrasonography in the SFP
Left paraspinal muscle (LPM) measurements in the SFP
Time frame: For the SFP technique, LPM measurement is planned to be done in between 1hr.20mins. and 1hr.30mins. time, for each participant, through study completion.
the diameter measurement of the LPM in millimeters via ultrasonography in the SFP
Right paraspinal muscle (RPM) measurements in the SFP
Time frame: For the SFP technique, RPM measurement is planned to be done in between 1hr.30mins. and 1hr.40mins. time, for each participant, through study completion.
the diameter measurement of the RPM in millimeters via ultrasonography in the SFP
The mean of bilateral paraspinal muscles (MPM) in the SFP
Time frame: For the SFP technique, MPM measurement is planned to be done in between 1hr.40mins. and 1hr.50mins. time, for each participant, through study completion.
Measured by ( [LPM+RPM]/2) in millimeters in the SFP
Subcutaneous tissue (ST) measurements in the SFP
Time frame: For the SFP technique, ST measurement is planned to be done in between 1hr.50mins. and 2hrs. time, for each participant, through study completion.
the thickness measurement of the subcutaneous tissue in millimeters via ultrasonography in the SFP
The skin to spinous process (S-SP) measurements in the SFP
Time frame: For the SFP technique, S-SP measurement is planned to be done in between 2hrs. and 2hr.10mins. time, for each participant, through study completion.
the depth measurement of the skin to spinous process in millimeters via ultrasonography in the SFP
the change of ISGO (ISGO ASP-SFP)
Time frame: ISGO in the ASP is measured in the first 10mins., and ISGO in the SFP is measured in between 1hr.10 mins. and 1hr.20mins. time, through study completion.
Measured by calculation; ([ISGO in the ASP in millimeters]-[ISGO in the SFP in millimeters])
the change of LPM (LPM ASP-SFP)
Time frame: LPM in the ASP is measured in between 10mins. and 20mins. time, and LPM in the SFP is measured in between 1hr.20mins and 1hr.30mins. time, through study completion.
Measured by calculation; ([LPM in ASP in millimeters]-[LPM in SFP in millimeters])
the change of RPM (RPM ASP-SFP)
Time frame: RPM in the ASP is measured in between 20mins. and 30mins. time, and RPM in the SFP is measured in between 1hr.30mins. and 1hr.40mins. time, through study completion.
Measured by calculation ([RPM in ASP in millimeters]-[RPM in SFP in millimeters])
the change of MPM (MPM ASP-SFP)
Time frame: MPM in the ASP is measured in between 30mins. and 40mins. time, and MPM in the SFP is measured in between 1hr.40mins and 1hr.50mins. time, through study completion.
Measured by calculation ([MPM in ASP in millimeters]-[MPM in SFP in millimeters])
the change of ST (ST ASP-SFP)
Time frame: ST in the ASP is measured in between 40mins. and 50mins. time, and in the SFP is measured in between 1hr.50mins and 2hrs. time, through study completion.
Measured by calculation ([ST in ASP in millimeters]-[ST in SFP in millimeters])
the change of S-SP (S-SP ASP-SFP)
Time frame: S-SP in the ASP is measured in between 50mins. and 1hr. time, and S-SP in the SFP is measured in between 2 hrs. and 2hrs.10mins. time, through study completion.
Measured by calculation ([S-SP in ASP in millimeters]-[S-SP in SFP in millimeters])

2 secondary outcomes

Comfort evaluation in the ASP via 5-point numerical rating scale (NRS)
Time frame: NRS measurement is planned to be done right after the ASP position in between 1hr. and 1hr.10mins. time, for each participant, through study completion.
Comfort evaluation in the SFP via 5-point numerical rating scale (NRS)
Time frame: NRS measurement is planned to be done right after the SFP position in between 2hrs.10mins. and 2hrs.20mins. time, for each participant, through study completion.

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 16 Nov 2018.
Background: PubMed 27687365Dimaculangan DP, Mazer JA, Maracaja-Neto LF. Sonographic evaluation of lumbar interlaminar space opening in a variety of patient body positions for optimal neuraxial anesthesia delivery. J Clin Anesth. 2016 Nov;34:159-65. doi: 10.1016/j.jclinane.2016.03.045. Epub 2016 May 6.
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.

ferda kartufan principal investigator

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing The SFP technique and The ASP technique in people with Anesthesia, Conduction, run by Yeditepe 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 3 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: finished, as of the sponsor's last update on 16 Nov 2018. 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?

Interspinous gap opening (ISGO) measurement in the ASP (time frame: For the ASP technique, ISGO is measured in the first 10 minutes(mins.) time, for each participant, through study completion.). The study lists 18 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 NCT03741465, which also lists 1 linked publication.

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 16 Nov 2018.