Transesophageal Echocardiography Contrast AgentsNCT02613052
Agitated Saline, Albumin, or Propofol-albumin Mixture for Enhanced Contrast in TEE Examinations
A study testing normal saline, human albumin and human albumin and propofol in people with Transesophageal Echocardiography Contrast Agents, run by University of California, San Diego at 1 site in United States.
Trial summary
This is a prospective, randomized, controlled study to determine if albumin and propofol or albumin only will provide superior qualitative contrast enhancement during TEE bubble studies compared to agitated saline. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transesophageal Echocardiography Contrast Agents
- What is being tested?
- normal saline, human albumin and human albumin and propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2016to Sep 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- cardiac surgical patients requiring a transesophageal echocardiogram (TEE)
Who cannot join
- allergy to propofol
- inability to place a TEE probe
- inability to obtain a TEE bicaval image
- known right to left intracardiac shunt
- pt refusal to accept human blood products including albumin
- pt refusal to participate in study
- vulnerable patients (pregnant women, prisoners, cognitively impaired, or institutionalized)
Trial locations and contacts
1 site in 1 country.
United States1 site
UC San Diego Sulpizio Cardiovascular Center
La Jolla, California, 92037
About this study
Official title: The Use of Agitated Saline, Albumin, or a Propofol-albumin Mixture for Enhanced Contrast in Bubble Studies During Transesophageal Echocardiographic Examinations
This is a prospective, randomized, controlled study to determine if albumin and propofol or albumin only will provide superior qualitative contrast enhancement during TEE bubble studies compared to agitated saline. Each patient will receive three randomized bubble studies (agitated saline, albumin, and albumin and propofol) using 10 ml of agitated contrast agent. The albumin and propofol mixture will consist of 7 mL of 5% albumin plus 3 mL of propofol (10 mg/mL). Each patient will undergo qualitative review of all 3 bubble studies by 10 different anesthesiologists and/or cardiologists credentialed to read echocardiographic studies at the time of the surgical procedure, and also with retrospective review of the echo video (~200 studies). A bicaval view will be obtained to record a 20 beat loop for each bubble study. Hemodynamic variables prior to injection of contrast agent; and 30 seconds, 1 minute and 2 minutes after injection will be monitored and recorded.
Read the detailed description
This is a prospective, randomized, controlled study to determine if albumin and propofol or albumin only will provide superior qualitative contrast enhancement during TEE bubble studies compared to the current standard of care contrast agent, agitated saline. The study will take place in the Operating Rooms (OR) at the UCSD Sulpizio Cardiovascular Center. The TEE studies will be reviewed by UCSD Anesthesiology or Cardiology faculty who are credentialed to read and interpret echocardiographic studies.
The study population will consist of 20 English-speaking patients and all will receive two doses of contrast, namely agitated albumin or propofol and albumin mixture, undergoing cardiac surgery who require TEE. Each patient will undergo qualitative review by 10 anesthesiologists and/or cardiologists credentialed to read echocardiographic studies at the time of the surgical procedure, and also with retrospective review of the echo video. The multiple reviewers per patient will increase the power of the study (~200 studies). Each patient will receive three bubble studies using 10 ml of agitated contrast agent as named above. The order in which each contrast agent is utilized, as well as the experimental contrast agent, is randomized and the interpreting physician is blinded to this information. Agitated saline (AS) alone will be used as a (third dose) control for each patient, which is the current standard contrast agent for TEE bubble studies. The other bubble studies will use an experimental agitated contrast agent, either a mixture of 7 mL albumin and 3 mL propofol (10 mg/ml) or 10 mL albumin (human). Saline and albumin 5% are intravenous fluids FDA approved for the use in restoration and maintenance of circulating of blood volume. Propofol is FDA approved for the use in induction or maintenance of general anesthesia.
The anesthesia care team, as per the standard care during UCSD cardiac surgical procedures, will place a TEE probe after induction of general anesthesia and endotracheal intubation. During the initial TEE exam, a bicaval view will be obtained. Both the order and type of experimental agitated contrast agent will be randomized and blinded to the sonographer and reviewer. A 20 beat loop will be recorded for each bubble study. Hemodynamic variables prior to injection of contrast agent; and 30 seconds, 1 minute and 2 minutes after injection are monitored and recorded. All recorded data will be anonymized prior to review. TEE is standard of care and routinely used in the care of cardiac surgery patients and is not performed solely for this study.
All anesthetic, surgical and medical interventions will be chosen and carried out by the surgical and anesthesia teams, including those involving invasive monitor placement, fluid administration, ventilator management and patient positioning.
Appropriate statistical analysis will be utilized to evaluate the difference in contrast enhancement in the saline only, albumin, and albumin and propofol groups.
The results of the study will be published in the peer-reviewed medical literature.
- Being tested
- normal saline, human albumin, human albumin and propofol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
normal salineDrug
Also called sodium chloride
10 mL of normal saline agitated prior to IV administration
human albuminDrug
10 mL of 5% albumin agitated prior to IV administration
human albumin and propofolDrug
Also called Diprivan
7 mL of 5% albumin mixed with 3 mL of propofol (10 mg/mL) agitated together prior to IV administration
| Study group | Role | What they receive |
|---|---|---|
| Agitated Normal Saline | Placebo comparator | Agitated saline is the current standard of care contrast agent used for bubble studies. 10 mL of agitated normal saline will be used for the bubble study. Receives: Drug: normal saline |
| Albumin only | Active comparator | 10 mL of agitated 5% albumin will be used for the bubbly study. Receives: Drug: human albumin |
| Albumin and Propofol | Experimental | 7 mL of 5% albumin and 3 mL of propofol (10 mg/mL) will be agitated together and used for the bubble study. Receives: Drug: human albumin and propofol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative enhancement in right atrial opacification during intraoperative TEE bubble studies
Number of participants with qualitatively enhanced right atrial opacification with albumin or albumin and propofol mixture compared to standard of care agitated normal saline, during TEE bubble studies using the bicaval view.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2015 (estimated)
- Study startJan 2016
- Primary completionJun 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Transesophageal Echocardiography Contrast AgentsStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Swapnil Khoche, University of California, San Diego
- Investigators
- Swapnil Khoche, MD, Principal investigator, University of California, San DiegoRyan YS Suda, MD, Study director, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02613052
- Sponsor's protocol ID
- 151360
- Status last verified
- Sep 2019
- First submitted
- 19 Nov 2015
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Meerbaum S. Introduction and general background. In: Myocardial Contrast Two-Dimensional Echocardiography, Meerbaum S, Meltzer R (Eds), Kluwer Academic Publishers, Boston 1989. p.2
Stewart MJ. Contrast echocardiography. Heart. 2003 Mar;89(3):342-8. doi: 10.1136/heart.89.3.342. No abstract available.
PubMed 12591856Attaran RR, Ata I, Kudithipudi V, Foster L, Sorrell VL. Protocol for optimal detection and exclusion of a patent foramen ovale using transthoracic echocardiography with agitated saline microbubbles. Echocardiography. 2006 Aug;23(7):616-22. doi: 10.1111/j.1540-8175.2006.00272.x.
PubMed 16911341Unger EC, Porter T, Culp W, Labell R, Matsunaga T, Zutshi R. Therapeutic applications of lipid-coated microbubbles. Adv Drug Deliv Rev. 2004 May 7;56(9):1291-314. doi: 10.1016/j.addr.2003.12.006.
PubMed 15109770Mulvagh SL, Rakowski H, Vannan MA, Abdelmoneim SS, Becher H, Bierig SM, Burns PN, Castello R, Coon PD, Hagen ME, Jollis JG, Kimball TR, Kitzman DW, Kronzon I, Labovitz AJ, Lang RM, Mathew J, Moir WS, Nagueh SF, Pearlman AS, Perez JE, Porter TR, Rosenbloom J, Strachan GM, Thanigaraj S, Wei K, Woo A, Yu EH, Zoghbi WA; American Society of Echocardiography. American Society of Echocardiography Consensus Statement on the Clinical Applications of Ultrasonic Contrast Agents in Echocardiography. J Am Soc Echocardiogr. 2008 Nov;21(11):1179-201; quiz 1281. doi: 10.1016/j.echo.2008.09.009.
PubMed 18992671Porter TR, Abdelmoneim S, Belcik JT, McCulloch ML, Mulvagh SL, Olson JJ, Porcelli C, Tsutsui JM, Wei K. Guidelines for the cardiac sonographer in the performance of contrast echocardiography: a focused update from the American Society of Echocardiography. J Am Soc Echocardiogr. 2014 Aug;27(8):797-810. doi: 10.1016/j.echo.2014.05.011. No abstract available.
PubMed 25085408Shapiro JR, Reisner SA, Lichtenberg GS, Meltzer RS. Intravenous contrast echocardiography with use of sonicated albumin in humans: systolic disappearance of left ventricular contrast after transpulmonary transmission. J Am Coll Cardiol. 1990 Dec;16(7):1603-7. doi: 10.1016/0735-1097(90)90308-c.
PubMed 2254545Davison P, Clift PF, Steeds RP. The role of echocardiography in diagnosis, monitoring closure and post-procedural assessment of patent foramen ovale. Eur J Echocardiogr. 2010 Dec;11(10):i27-34. doi: 10.1093/ejechocard/jeq120.
PubMed 21078836Baker MT, Naguib M. Propofol: the challenges of formulation. Anesthesiology. 2005 Oct;103(4):860-76. doi: 10.1097/00000542-200510000-00026.
PubMed 16192780de Jong N, Emmer M, van Wamel A, Versluis M. Ultrasonic characterization of ultrasound contrast agents. Med Biol Eng Comput. 2009 Aug;47(8):861-73. doi: 10.1007/s11517-009-0497-1. Epub 2009 May 26.
PubMed 19468770Kitzman DW, Goldman ME, Gillam LD, Cohen JL, Aurigemma GP, Gottdiener JS. Efficacy and safety of the novel ultrasound contrast agent perflutren (definity) in patients with suboptimal baseline left ventricular echocardiographic images. Am J Cardiol. 2000 Sep 15;86(6):669-74. doi: 10.1016/s0002-9149(00)01050-x.
PubMed 10980221Dewhirst E, et al. The Use of a Propofol-Saline Mixture for Enhanced Contrast in Bubble Studies During Echocardiographic Examinations. Society of Pediatric Anesthesia Meeting (Winter 2012).
Geny B, Mettauer B, Muan B, Bischoff P, Epailly E, Piquard F, Eisenmann B, Haberey P. Safety and efficacy of a new transpulmonary echo contrast agent in echocardiographic studies in patients. J Am Coll Cardiol. 1993 Oct;22(4):1193-8. doi: 10.1016/0735-1097(93)90437-6.
PubMed 8409060
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Agitated Saline, Albumin, or a Propofol-albumin Mixture for Enhanced Contrast in Bubble Studies During Transesophageal Echocardiographic Examinations
- ClinicalTrials.gov ID
- NCT02613052
- Acronym / sponsor ID
- 151360
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 24 Nov 2015 (estimated)
- 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.
This is a prospective, randomized, controlled study to determine if albumin and propofol or albumin only will provide superior qualitative contrast enhancement during TEE bubble studies compared to agitated saline. Each patient will receive three randomized bubble studies (agitated saline, albumin, and albumin and propofol) using 10 ml of agitated contrast agent. The albumin and propofol mixture will consist of 7 mL of 5% albumin plus 3 mL of propofol (10 mg/mL). Each patient will undergo qualitative review of all 3 bubble studies by 10 different anesthesiologists and/or cardiologists credentialed to read echocardiographic studies at the time of the surgical procedure, and also with retrospective review of the echo video (~200 studies). A bicaval view will be obtained to record a 20 beat loop for each bubble study. Hemodynamic variables prior to injection of contrast agent; and 30 seconds, 1 minute and 2 minutes after injection will be monitored and recorded.
Detailed description
This is a prospective, randomized, controlled study to determine if albumin and propofol or albumin only will provide superior qualitative contrast enhancement during TEE bubble studies compared to the current standard of care contrast agent, agitated saline. The study will take place in the Operating Rooms (OR) at the UCSD Sulpizio Cardiovascular Center. The TEE studies will be reviewed by UCSD Anesthesiology or Cardiology faculty who are credentialed to read and interpret echocardiographic studies.
The study population will consist of 20 English-speaking patients and all will receive two doses of contrast, namely agitated albumin or propofol and albumin mixture, undergoing cardiac surgery who require TEE. Each patient will undergo qualitative review by 10 anesthesiologists and/or cardiologists credentialed to read echocardiographic studies at the time of the surgical procedure, and also with retrospective review of the echo video. The multiple reviewers per patient will increase the power of the study (~200 studies). Each patient will receive three bubble studies using 10 ml of agitated contrast agent as named above. The order in which each contrast agent is utilized, as well as the experimental contrast agent, is randomized and the interpreting physician is blinded to this information. Agitated saline (AS) alone will be used as a (third dose) control for each patient, which is the current standard contrast agent for TEE bubble studies. The other bubble studies will use an experimental agitated contrast agent, either a mixture of 7 mL albumin and 3 mL propofol (10 mg/ml) or 10 mL albumin (human). Saline and albumin 5% are intravenous fluids FDA approved for the use in restoration and maintenance of circulating of blood volume. Propofol is FDA approved for the use in induction or maintenance of general anesthesia.
The anesthesia care team, as per the standard care during UCSD cardiac surgical procedures, will place a TEE probe after induction of general anesthesia and endotracheal intubation. During the initial TEE exam, a bicaval view will be obtained. Both the order and type of experimental agitated contrast agent will be randomized and blinded to the sonographer and reviewer. A 20 beat loop will be recorded for each bubble study. Hemodynamic variables prior to injection of contrast agent; and 30 seconds, 1 minute and 2 minutes after injection are monitored and recorded. All recorded data will be anonymized prior to review. TEE is standard of care and routinely used in the care of cardiac surgery patients and is not performed solely for this study.
All anesthetic, surgical and medical interventions will be chosen and carried out by the surgical and anesthesia teams, including those involving invasive monitor placement, fluid administration, ventilator management and patient positioning.
Appropriate statistical analysis will be utilized to evaluate the difference in contrast enhancement in the saline only, albumin, and albumin and propofol groups.
The results of the study will be published in the peer-reviewed medical literature.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Agitated Normal Saline | Placebo comparator | Drug: normal salineAgitated saline is the current standard of care contrast agent used for bubble studies. 10 mL of agitated normal saline will be used for the bubble study. |
| Albumin only | Active comparator | Drug: human albumin10 mL of agitated 5% albumin will be used for the bubbly study. |
| Albumin and Propofol | Experimental | Drug: human albumin and propofol7 mL of 5% albumin and 3 mL of propofol (10 mg/mL) will be agitated together and used for the bubble study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- cardiac surgical patients requiring a transesophageal echocardiogram (TEE)
Key exclusion criteria (7 listed)
- allergy to propofol
- inability to place a TEE probe
- inability to obtain a TEE bicaval image
- known right to left intracardiac shunt
- pt refusal to accept human blood products including albumin
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 |
|---|---|---|
| normal salineAlso: sodium chloride10 mL of normal saline agitated prior to IV administration | Drug | Agitated Normal Saline |
| human albumin10 mL of 5% albumin agitated prior to IV administration | Drug | Albumin only |
| human albumin and propofolAlso: Diprivan7 mL of 5% albumin mixed with 3 mL of propofol (10 mg/mL) agitated together prior to IV administration | Drug | Albumin and Propofol |
Primary outcome
Qualitative enhancement in right atrial opacification during intraoperative TEE bubble studies
Time frame: 6 months
Number of participants with qualitatively enhanced right atrial opacification with albumin or albumin and propofol mixture compared to standard of care agitated normal saline, during TEE bubble studies using the bicaval view.
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 25 Sep 2019.
- BackgroundMeerbaum S. Introduction and general background. In: Myocardial Contrast Two-Dimensional Echocardiography, Meerbaum S, Meltzer R (Eds), Kluwer Academic Publishers, Boston 1989. p.2
- Background: PubMed 12591856Stewart MJ. Contrast echocardiography. Heart. 2003 Mar;89(3):342-8. doi: 10.1136/heart.89.3.342. No abstract available.
- Background: PubMed 16911341Attaran RR, Ata I, Kudithipudi V, Foster L, Sorrell VL. Protocol for optimal detection and exclusion of a patent foramen ovale using transthoracic echocardiography with agitated saline microbubbles. Echocardiography. 2006 Aug;23(7):616-22. doi: 10.1111/j.1540-8175.2006.00272.x.
- Background: PubMed 15109770Unger EC, Porter T, Culp W, Labell R, Matsunaga T, Zutshi R. Therapeutic applications of lipid-coated microbubbles. Adv Drug Deliv Rev. 2004 May 7;56(9):1291-314. doi: 10.1016/j.addr.2003.12.006.
- Background: PubMed 18992671Mulvagh SL, Rakowski H, Vannan MA, Abdelmoneim SS, Becher H, Bierig SM, Burns PN, Castello R, Coon PD, Hagen ME, Jollis JG, Kimball TR, Kitzman DW, Kronzon I, Labovitz AJ, Lang RM, Mathew J, Moir WS, Nagueh SF, Pearlman AS, Perez JE, Porter TR, Rosenbloom J, Strachan GM, Thanigaraj S, Wei K, Woo A, Yu EH, Zoghbi WA; American Society of Echocardiography. American Society of Echocardiography Consensus Statement on the Clinical Applications of Ultrasonic Contrast Agents in Echocardiography. J Am Soc Echocardiogr. 2008 Nov;21(11):1179-201; quiz 1281. doi: 10.1016/j.echo.2008.09.009.
- Background: PubMed 25085408Porter TR, Abdelmoneim S, Belcik JT, McCulloch ML, Mulvagh SL, Olson JJ, Porcelli C, Tsutsui JM, Wei K. Guidelines for the cardiac sonographer in the performance of contrast echocardiography: a focused update from the American Society of Echocardiography. J Am Soc Echocardiogr. 2014 Aug;27(8):797-810. doi: 10.1016/j.echo.2014.05.011. No abstract available.
- Background: PubMed 2254545Shapiro JR, Reisner SA, Lichtenberg GS, Meltzer RS. Intravenous contrast echocardiography with use of sonicated albumin in humans: systolic disappearance of left ventricular contrast after transpulmonary transmission. J Am Coll Cardiol. 1990 Dec;16(7):1603-7. doi: 10.1016/0735-1097(90)90308-c.
- Background: PubMed 21078836Davison P, Clift PF, Steeds RP. The role of echocardiography in diagnosis, monitoring closure and post-procedural assessment of patent foramen ovale. Eur J Echocardiogr. 2010 Dec;11(10):i27-34. doi: 10.1093/ejechocard/jeq120.
- Background: PubMed 16192780Baker MT, Naguib M. Propofol: the challenges of formulation. Anesthesiology. 2005 Oct;103(4):860-76. doi: 10.1097/00000542-200510000-00026.
- Background: PubMed 19468770de Jong N, Emmer M, van Wamel A, Versluis M. Ultrasonic characterization of ultrasound contrast agents. Med Biol Eng Comput. 2009 Aug;47(8):861-73. doi: 10.1007/s11517-009-0497-1. Epub 2009 May 26.
- Background: PubMed 10980221Kitzman DW, Goldman ME, Gillam LD, Cohen JL, Aurigemma GP, Gottdiener JS. Efficacy and safety of the novel ultrasound contrast agent perflutren (definity) in patients with suboptimal baseline left ventricular echocardiographic images. Am J Cardiol. 2000 Sep 15;86(6):669-74. doi: 10.1016/s0002-9149(00)01050-x.
- BackgroundDewhirst E, et al. The Use of a Propofol-Saline Mixture for Enhanced Contrast in Bubble Studies During Echocardiographic Examinations. Society of Pediatric Anesthesia Meeting (Winter 2012).
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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.
Swapnil Khoche, MD principal investigator
University of California, San Diego
Ryan YS Suda, MD study director
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing normal saline, human albumin and human albumin and propofol in people with Transesophageal Echocardiography Contrast Agents, run by University of California, San Diego at 1 site in United States.
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 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2019. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Qualitative enhancement in right atrial opacification during intraoperative TEE bubble studies (time frame: 6 months). 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 NCT02613052, which also lists 13 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 25 Sep 2019.