Mechanical VentilationCONFIDENCENCT05188092
Lung Ultrasound-Guided Fluid Deresuscitation in ICU Patients
A study testing Lung ultrasound guided deresuscitation in people with Mechanical Ventilation and Fluid Overload, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 3 sites in Netherlands.
Trial summary
Timely recognition and treatment of fluid overload can expedite liberation from invasive mechanical ventilation in intensive care unit (ICU) patients. Lung ultrasound (LUS) is an easy to learn, safe, cheap and noninvasive bedside imaging tool with high accuracy for pulmonary edema and pleural effusions in ICU… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation, Fluid Overload, Deresuscitation
- What is being tested?
- Lung ultrasound guided deresuscitation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 998 participants
- Where
- 3 sitesNetherlands
- Study dates
- 22 Dec 2021to 9 Mar 2026
- 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
- Admission to one of the participating ICUs;
- Invasively ventilated for less than 24 hours at randomization;
- Expected to be under invasive ventilation for longer than 24 hours after randomization.
Who cannot join
- Age below 18 years old;
- Suspected or confirmed pregnancy;
- Participation in other interventional trials with similar endpoints;
- Use of long term home mechanical ventilation;
- Neurological condition that can prolong duration of mechanical ventilation (i.e.Guillain-Barré syndrome, high spinal cord lesion, amyotrophic lateral sclerosis, multiple sclerosis, or myasthenia gravis);
- Conditions in which LUS cannot be performed or correctly interpreted (i.e. chest wall abnormalities, morbid obesity, and pre-existing interstitial lung disease);
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- Conditions in which targeting a negative fluid balance is discouraged (i.e. subarachnoid bleeding, severe rhabdomyolysis (CK > 20.000);
- Previous participation in this RCT;
- Patients transferred from another center and invasively ventilated for longer than 24 hours.
Trial locations and contacts
3 sites in 1 country.
Netherlands3 sites
Amsterdam UMC, location VUMC
Amsterdam, North Holland, 1081 HV
Amsterdam UMC, location AMC
Amsterdam, North Holland, 1105AZ
Rijnstate
Arnhem, Gelderland, 6800 TA
About this study
Official title: Effect of Lung Ultrasound-Guided Fluid Deresuscitation on Duration of Ventilation in Intensive Care Unit Patients (CONFIDENCE)
Timely recognition and treatment of fluid overload can expedite liberation from invasive mechanical ventilation in intensive care unit (ICU) patients. Lung ultrasound (LUS) is an easy to learn, safe, cheap and noninvasive bedside imaging tool with high accuracy for pulmonary edema and pleural effusions in ICU patients. The aim of this study is to assess the effect of LUS-guided deresuscitation on duration of invasive ventilation in ICU patients. The investigators hypothesize that LUS-guided fluid deresuscitation is superior to routine fluid deresuscitation (not using LUS) with regard to duration of invasive ventilation.
This study is an international multicenter randomized clinical trial (RCT) in invasively ventilated ICU patients.This study will include 1,000 consecutively admitted invasively ventilated adult ICU patients, who are expected not to be extubated within the next 24 hours after randomization. Patients are randomly assigned to the intervention group, in which fluid deresuscitation is guided by repeated LUS, or the control group, in which fluid deresuscitation is at the discretion of the treating physician (not using LUS).
Read the detailed description
Objective:
The aim of this study is to assess the effect of LUS-guided deresuscitation on duration of invasive ventilation in ICU patients.
Hypothesis:
LUS-guided fluid deresuscitation is superior to routine fluid deresuscitation (not using LUS) with regard to duration of invasive ventilation.
Study design:
The CONFIDENCE study is an investigator-initiated, national, multicenter, randomized clinical trial in critically ill invasively ventilated patients admitted to the ICUs of participating hospitals.
Study population:
Adult patients admitted to ICUs in multiple countries
Sample size calculation:
The sample size is computed on the basis of the hypothesis that LUS guided deresuscitation is associated with a reduction of two days of ventilation. Assuming a mean (±SD) number of VFD-28 of 13±11 days, the ivenstigators estimate that a sample of 1000 patients (500 per group) is needed to have 80% power, at a two-tailed significance level of 0.05, to detect a mean between-group difference of 2 VFD-28, and allowing an anticipated dropout rate of 5%.
Methods:
Patients in participating intensive care units (ICU) are screened for eligibility. Inclusion and randomization will occur within 24 hours after meeting the inclusion criteria. If possible, informed consent from the legal representative will be obtained before randomization but no longer than 48 hours after meeting the inclusion criteria.
Patients are eligible if they are admitted to one of the participating ICUs, are invasively ventilated for less than 24 hours at randomization and expected to be under invasive ventilation for longer than 24 hours after randomization.
Randomization will be performed using Castor Electronic Data Capture (EDC). A dedicated, password protected, encrypted website. Randomization sequence is generated by a dedicated computer randomization software program. Due to the nature of the intervention, blinding of the caregivers is not possible.
Patients will be randomly assigned in a 1:1 ratio to lung guided fluid deresuscitation or routine fluid deresuscitation. Randomization will be stratified per center.
Lung ultrasound guided deresuscitation: with lung ultrasound (LUS)-guided fluid deresuscitation, LUS examinations are performed at least onze a day in hemodynamically stable patients, defined as a mean arterial pressure (MAP) ≥ 65 mmHg (with vasopressor dose decreasing and norepinephrine ≤ 0.2 μg/kg/min), and no new clear signs of hypoperfusion such as mottled skin and capillary refill time > 3 seconds and/or new oliguria (urine output < 0.3-0.5ml/kg/hour for the previous 6 hours). Target MAP can be changed in conditions in which 65 mmHg is not sufficient (i.e. history of chronic hypertension). In these cases the target MAP is at the discretion of the treating physician. 12-region LUS is performed, by a trained healthcare provider, and each region is scanned for the presence of B-lines and pleural effusions and scored using the lung ultrasound score. After extubation, lung ultrasound is continued once a day until day 28 or until discharge (whatever comes first) to monitor reappearance of pulmonary fluid overload or pleural effusion. In case of reappearance (or increase) of pulmonary fluid overload or pleural effusion, fluid withdrawal is started again according to the treatment protocol.
Routine deresuscitation: in routine fluid deresuscitation, in which fluid withdrawal is started and continued at the discretion of the treating physician, factors guiding fluid deresuscitation are chosen by the treating physician and may include the following: physical examination, laboratory values (e.g. BNP), chest x-ray, PiCCO or pulmonary artery catheters. LUS examinations are not performed to guide fluid deresuscitation in this group.
In both groups patients are extubated if standard extubation criteria are fulfilled, i.e., normal body temperature, patient awake and responsive/cooperative, adequate cough reflex, adequate oxygenation and ventilation, and hemodynamically stable.
Monitoring:
Monitoring of patients safety and reviewing of safety issues is performed by a designated independent Data Safety and Monitoring Board (DSMB).The DSMB watches over the ethics of conducting the study in accordance with the Declaration of Helsinki.
- Being tested
- Lung ultrasound guided deresuscitation
- Medical subject headings
- Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung ultrasound guided deresuscitationOther
With every new LUS examination, the following scenarios, with distinct recommendations, are possible:
- LUS observations suggest massive pulmonary fluid overload, with the recommendation to minimize fluid infusion and start fluid withdrawal, targeting a negative fluid balance of at least -1500 ml in the next 24 hours;
- LUS suggests some pulmonary edema and/or significant pleural effusion. These LUS observations suggest little pulmonary fluid overload, with the suggestion to minimize fluid infusion and start fluid withdrawal, targeting a negative fluid balance at least -500 ml in the next 24 hours;
- LUS suggests absence of pulmonary edema and no pleural effusion. These LUS observations suggest no fluid overload, with the suggestion to target a neutral fluid balance in the next 24 hours.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Routine fluid deresuscitation in which fluid withdrawal is started and continued at the discretion of the treating physician. |
| Intervention | Active comparator | Deresuscitation is guided by lung ultrasound observations. Receives: Other: Lung ultrasound guided deresuscitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilator free days(VFD) and alive at day 28
Patient is alive and breathes without assistance of the mechanical ventilator, if the period of unassisted breathing lasted at least 24 consecutive hours:
- VFD-28 = 0 if subject dies within 28 days of mechanical ventilation
- VFD-28 = 28 - x if successfully liberated from ventilation x days after initiation Succcessful liberation: extubation (planned or unplanned) without death or reintubation within the next 72 hours
- VFD-28 = 0 if the subject is mechanically ventilated for ≥ 28 days
Measured: 28 days after randomisation
Secondary outcomes (9)
Duration of ventilation
Duration of ventilation in survivors
Measured: 28 days
ICU length of stay
Length of stay in the intensive care unit
Measured: 28 days
Hospital length of stay
Length of stay in the hospital
Measured: 28 days
28 day mortality
Mortality after 28 days
Measured: 28 days
90 day mortality
Mortality after 90 days
Measured: 90 days
Incidences of reintubations
Need of reintubation within 72 hours after extubation
Measured: 28 days
Cumulative fluid balances after randomization
Cumulative fluid balance on day 1-7 after randomization;
Measured: 7 days
Cumulative fluid balances after start of lung ultrasound examination
Cumulative fluid balance on day 1-7 after start of lung ultrasound examinations;
Measured: 7 days
Incidence of acute kidney injury
Kidney injury with Kidney Disease Improving Global Outcomes (KDIGO) stadium ≥ 2
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study start22 Dec 2021
- Primary completion6 Jan 2026
- Study completion9 Mar 2026
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 Mechanical VentilationStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 998 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Responsible party
- Principal investigator, Prof. Dr. Marcus J. Schultz, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Marcus J Schultz, Prof, Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Pieter Roel Tuinman, Dr, Principal investigator, Amsterdam UMC, location VUmcFrederique Paulus, Dr, Study director, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Leo MA Heunks, Study director, Amsterdam UMC, location VUmc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05188092
- Sponsor's protocol ID
- CONFIDENCE
- Acronym
- CONFIDENCE
- Status last verified
- Oct 2026
- First submitted
- 22 Dec 2021
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Blok SG, Mousa A, Brouwer MG, de Grooth HJ, Neto AS, Blans MJ, den Boer S, Dormans T, Endeman H, Roeleveld T, Scholten H, van Slobbe-Bijlsma ER, Scholten E, Touw H, van der Ven FSLIM, Wils EJ, van Westerloo DJ, Heunks LMA, Schultz MJ, Paulus F, Tuinman PR. Effect of lung ultrasound-guided fluid deresuscitation on duration of ventilation in intensive care unit patients (CONFIDENCE): protocol for a multicentre randomised controlled trial. Trials. 2023 Mar 24;24(1):226. doi: 10.1186/s13063-023-07171-w.
PubMed 36964614
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Lung Ultrasound-Guided Fluid Deresuscitation on Duration of Ventilation in Intensive Care Unit Patients (CONFIDENCE)
- ClinicalTrials.gov ID
- NCT05188092
- Acronym / sponsor ID
- CONFIDENCE / CONFIDENCE
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 998 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- ZonMw: The Netherlands Organisation for Health Research and Development
- Study start
- 22 Dec 2021 (actual)
- Primary completion
- 6 Jan 2026 (actual)
- Study completion
- 9 Mar 2026 (actual)
- First posted
- 12 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Timely recognition and treatment of fluid overload can expedite liberation from invasive mechanical ventilation in intensive care unit (ICU) patients. Lung ultrasound (LUS) is an easy to learn, safe, cheap and noninvasive bedside imaging tool with high accuracy for pulmonary edema and pleural effusions in ICU patients. The aim of this study is to assess the effect of LUS-guided deresuscitation on duration of invasive ventilation in ICU patients. The investigators hypothesize that LUS-guided fluid deresuscitation is superior to routine fluid deresuscitation (not using LUS) with regard to duration of invasive ventilation.
This study is an international multicenter randomized clinical trial (RCT) in invasively ventilated ICU patients.This study will include 1,000 consecutively admitted invasively ventilated adult ICU patients, who are expected not to be extubated within the next 24 hours after randomization. Patients are randomly assigned to the intervention group, in which fluid deresuscitation is guided by repeated LUS, or the control group, in which fluid deresuscitation is at the discretion of the treating physician (not using LUS).
Detailed description
Objective:
The aim of this study is to assess the effect of LUS-guided deresuscitation on duration of invasive ventilation in ICU patients.
Hypothesis:
LUS-guided fluid deresuscitation is superior to routine fluid deresuscitation (not using LUS) with regard to duration of invasive ventilation.
Study design:
The CONFIDENCE study is an investigator-initiated, national, multicenter, randomized clinical trial in critically ill invasively ventilated patients admitted to the ICUs of participating hospitals.
Study population:
Adult patients admitted to ICUs in multiple countries
Sample size calculation:
The sample size is computed on the basis of the hypothesis that LUS guided deresuscitation is associated with a reduction of two days of ventilation. Assuming a mean (±SD) number of VFD-28 of 13±11 days, the ivenstigators estimate that a sample of 1000 patients (500 per group) is needed to have 80% power, at a two-tailed significance level of 0.05, to detect a mean between-group difference of 2 VFD-28, and allowing an anticipated dropout rate of 5%.
Methods:
Patients in participating intensive care units (ICU) are screened for eligibility. Inclusion and randomization will occur within 24 hours after meeting the inclusion criteria. If possible, informed consent from the legal representative will be obtained before randomization but no longer than 48 hours after meeting the inclusion criteria.
Patients are eligible if they are admitted to one of the participating ICUs, are invasively ventilated for less than 24 hours at randomization and expected to be under invasive ventilation for longer than 24 hours after randomization.
Randomization will be performed using Castor Electronic Data Capture (EDC). A dedicated, password protected, encrypted website. Randomization sequence is generated by a dedicated computer randomization software program. Due to the nature of the intervention, blinding of the caregivers is not possible.
Patients will be randomly assigned in a 1:1 ratio to lung guided fluid deresuscitation or routine fluid deresuscitation. Randomization will be stratified per center.
Lung ultrasound guided deresuscitation: with lung ultrasound (LUS)-guided fluid deresuscitation, LUS examinations are performed at least onze a day in hemodynamically stable patients, defined as a mean arterial pressure (MAP) ≥ 65 mmHg (with vasopressor dose decreasing and norepinephrine ≤ 0.2 μg/kg/min), and no new clear signs of hypoperfusion such as mottled skin and capillary refill time > 3 seconds and/or new oliguria (urine output < 0.3-0.5ml/kg/hour for the previous 6 hours). Target MAP can be changed in conditions in which 65 mmHg is not sufficient (i.e. history of chronic hypertension). In these cases the target MAP is at the discretion of the treating physician. 12-region LUS is performed, by a trained healthcare provider, and each region is scanned for the presence of B-lines and pleural effusions and scored using the lung ultrasound score. After extubation, lung ultrasound is continued once a day until day 28 or until discharge (whatever comes first) to monitor reappearance of pulmonary fluid overload or pleural effusion. In case of reappearance (or increase) of pulmonary fluid overload or pleural effusion, fluid withdrawal is started again according to the treatment protocol.
Routine deresuscitation: in routine fluid deresuscitation, in which fluid withdrawal is started and continued at the discretion of the treating physician, factors guiding fluid deresuscitation are chosen by the treating physician and may include the following: physical examination, laboratory values (e.g. BNP), chest x-ray, PiCCO or pulmonary artery catheters. LUS examinations are not performed to guide fluid deresuscitation in this group.
In both groups patients are extubated if standard extubation criteria are fulfilled, i.e., normal body temperature, patient awake and responsive/cooperative, adequate cough reflex, adequate oxygenation and ventilation, and hemodynamically stable.
Monitoring:
Monitoring of patients safety and reviewing of safety issues is performed by a designated independent Data Safety and Monitoring Board (DSMB).The DSMB watches over the ethics of conducting the study in accordance with the Declaration of Helsinki.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Routine fluid deresuscitation in which fluid withdrawal is started and continued at the discretion of the treating physician. |
| Intervention | Active comparator | Other: Lung ultrasound guided deresuscitationDeresuscitation is guided by lung ultrasound observations. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Admission to one of the participating ICUs;
- Invasively ventilated for less than 24 hours at randomization;
- Expected to be under invasive ventilation for longer than 24 hours after randomization.
Key exclusion criteria (9 listed)
- Age below 18 years old;
- Suspected or confirmed pregnancy;
- Participation in other interventional trials with similar endpoints;
- Use of long term home mechanical ventilation;
- Neurological condition that can prolong duration of mechanical ventilation (i.e.Guillain-Barré syndrome, high spinal cord lesion, amyotrophic lateral sclerosis, multiple sclerosis, or myasthenia gravis);
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 |
|---|---|---|
| Lung ultrasound guided deresuscitationWith every new LUS examination, the following scenarios, with distinct recommendations, are possible: 1. LUS observations suggest massive pulmonary fluid overload, with the recommendation to minimize fluid infusion and start fluid withdrawal, targeting a negative fluid balance of at least -1500 ml in the next 24 hours; 2. LUS suggests some pulmonary edema and/or significant pleural effusion. These LUS observations suggest little pulmonary fluid overload, with the suggestion to minimize fluid infusion and start fluid withdrawal, targeting a negative fluid balance at least -500 ml in the next 24 hours; 3. LUS suggests absence of pulmonary edema and no pleural effusion. These LUS observations suggest no fluid overload, with the suggestion to target a neutral fluid balance in the next 24 hours. | Other | Intervention |
Primary outcome
Ventilator free days(VFD) and alive at day 28
Time frame: 28 days after randomisation
Patient is alive and breathes without assistance of the mechanical ventilator, if the period of unassisted breathing lasted at least 24 consecutive hours: * VFD-28 = 0 if subject dies within 28 days of mechanical ventilation * VFD-28 = 28 - x if successfully liberated from ventilation x days after initiation Succcessful liberation: extubation (planned or unplanned) without death or reintubation within the next 72 hours * VFD-28 = 0 if the subject is mechanically ventilated for ≥ 28 days
9 secondary outcomes
Duration of ventilation
Time frame: 28 days
ICU length of stay
Time frame: 28 days
Hospital length of stay
Time frame: 28 days
28 day mortality
Time frame: 28 days
90 day mortality
Time frame: 90 days
Incidences of reintubations
Time frame: 28 days
Cumulative fluid balances after randomization
Time frame: 7 days
Cumulative fluid balances after start of lung ultrasound examination
Time frame: 7 days
Incidence of acute kidney injury
Time frame: 28 days
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 30 Oct 2026.
- Derived from this study: PubMed 36964614Blok SG, Mousa A, Brouwer MG, de Grooth HJ, Neto AS, Blans MJ, den Boer S, Dormans T, Endeman H, Roeleveld T, Scholten H, van Slobbe-Bijlsma ER, Scholten E, Touw H, van der Ven FSLIM, Wils EJ, van Westerloo DJ, Heunks LMA, Schultz MJ, Paulus F, Tuinman PR. Effect of lung ultrasound-guided fluid deresuscitation on duration of ventilation in intensive care unit patients (CONFIDENCE): protocol for a multicentre randomised controlled trial. Trials. 2023 Mar 24;24(1):226. doi: 10.1186/s13063-023-07171-w.
- Individual participant dataSharing planned: Yes
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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.
Marcus J Schultz, Prof principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Pieter Roel Tuinman, Dr principal investigator
Amsterdam UMC, location VUmc
Frederique Paulus, Dr study director
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lung ultrasound guided deresuscitation in people with Mechanical Ventilation and Fluid Overload, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 3 sites in Netherlands.
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 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Netherlands. 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?
Ventilator free days(VFD) and alive at day 28 (time frame: 28 days after randomisation). 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 NCT05188092, 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 30 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.