ARDS (Moderate or Severe)REEFNCT07203781
PEEP-induced Effects on Respiratory dRivE and EFfort
A study testing PEEP level changes in people with ARDS (Moderate or Severe) and Acute Hypoxemic Respiratory Failure, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
Rationale: In patients with acute hypoxemic respiratory failure (AHRF), preserving spontaneous breathing during mechanical ventilation offers physiological benefits, but also carries risks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ARDS (Moderate or Severe), Acute Hypoxemic Respiratory Failure
- What is being tested?
- PEEP level changes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNetherlands
- Study dates
- 2 Sep 2025to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Acute hypoxemic respiratory failure (AHRF) with a PaO2/FiO2-ratio ≤ 200
- Patient on invasive assisted mechanical ventilation in pressure support mode exhibiting valid inspiratory efforts (occlusion pressure > 5 cmH2O).
Who cannot join
- Pre-existent neuromuscular disease
- History of chronic respiratory failure requiring long-term oxygen therapy
- Muscle paralysis
- Pneumothorax
- Contra-indication to EIT monitoring (e.g. burns, pacemaker, thoracic wounds limiting electrode placement)
- Contra-indications for EAdi or oesophageal balloon catheter placement (e.g. history of gastric bypass surgery, gastro-oesophageal junction surgery, oesophageal stricture, recent upper gastrointestinal hemorrhage or known/suspected varices).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Radboudumc
Nijmegen, Gelderland, 6525 GA
Jonne Doorduin, PhD, 06-50155757, Jonne.Doorduin@Radboudumc.nl
About this study
Official title: Unraveling PEEP-induced Effects on Respiratory dRivE and EFfort in Acute Hypoxemic Respiratory Failure: the REEF Study
Rationale:
In patients with acute hypoxemic respiratory failure (AHRF), preserving spontaneous breathing during mechanical ventilation offers physiological benefits, but also carries risks. While spontaneous breathing improves gas exchange and limits diaphragm atrophy, strong inspiratory efforts may worsen lung and diaphragm injury. Balancing these factors requires refined and tailored strategies, such as the modulation of PEEP. However, the impact of PEEP on neural respiratory drive and inspiratory effort is very heterogenous, and these two entities have only been studied separately in limited subsets of patients and healthy subjects. Additionally, it remains unclear whether the major determinant of PEEP-induced changes in respiratory drive and effort is represented by variations in diaphragm geometry, lung compliance, or by the presence of expiratory muscles recruitment, which may counteract its effect.
Read more
Objective:
The primary objective is to determine the effect of PEEP on diaphragm neuromechanical efficiency (i.e. an index of neural respiratory drive and inspiratory effort) in patients with acute hypoxemic respiratory failure during invasive assisted mechanical ventilation. The secondary objective is to determine the major physiological contributors to PEEP-mediated changes in diaphragm neuromechanical efficiency.
Study design: Prospective, physiological study. Study population: Invasively mechanically ventilated adult patients admitted to the ICU.
Intervention:
For each patient, six different PEEP levels (15-12-10-8-5-2 cmH2O) will be tested during a decremental PEEP trial. During each step, neural respiratory drive, inspiratory effort, expiratory muscle activity, lung inflation pattern through electrical impedance tomography, respiratory muscle geometry and function through ultrasound and surface EMG, gas exchange and hemodynamics data will be collected.
Main study parameters/endpoints:
The primary outcome of the study will be the evaluation of PEEP-mediated changes in diaphragm neuromechanical efficiency (NME).
- Being tested
- PEEP level changes
- Keywords
- PEEP, effort, drive, PSV, pressure support ventilation, AHRF, ARDS, diaphragm, NME
- Medical subject headings
- Lymphoma, Follicular, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PEEP level changesOther
For each patient, six different PEEP levels (15-12-10-8-5-2 cmH2O) will be tested during a decremental PEEP trial. During each step, neural respiratory drive, inspiratory effort, expiratory muscle activity, lung inflation pattern through electrical impedance tomography, respiratory muscle geometry and function through ultrasound and surface EMG, gas exchange and hemodynamics data will be collected.
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | Not described Receives: Other: PEEP level changes |
What is being measured
The primary outcome is the main question the study is designed to answer.
PEEP-related changes in diaphragm neuromechanical efficiency (NME)
The primary endpoint of this study will be the evaluation of PEEP-induced changes in diaphragm neuromechanical efficiency (NME, cmH2O/µV), calculated as the ratio between the change in transdiaphragmatic pressure (representing inspiratory effort in cmH2O and assessed through the use of esophageal and gastric manometry) and the change in diaphragm electrical activity (neural respiratory drive, expressed in µV and measured through diaphragm EMG by a dedicated nasogastric tube) for each inspiration (ΔPdi/ΔEAdi). NME is an index of diaphragm efficiency and of potential electromechanical uncoupling, a key PEEP-mediated effect on the diaphragm. Its assessment combines changes in neural respiratory drive and inspiratory effort after a change in PEEP, which will be assessed individually and combined as a ratio as primary outcome.
Measured: Measurements will be conducted throughout the protocol at each of the 6 PEEP levels tested: 15, 12, 10, 8, 5 and 2 cmH2O. Each PEEP step will last 30 minutes, and measurements will be collected recording the last 10 minutes of each step.
Secondary outcomes (13)
PEEP-induced changes in inspiratory effort
Inspiratory effort will be assessed through esophageal pressure monitoring and expressed in cmH2O.
Measured: Measurements will be conducted throughout the protocol at each of the 6 PEEP levels tested: 15, 12, 10, 8, 5 and 2 cmH2O. Each PEEP step will last 30 minutes, and measurements will be collected recording the last 10 minutes of each step.
PEEP-induced changes in neural respiratory drive
Neural respiratory drive will be assessed through the monitoring of the electrical activity of the diaphragm, performed with the use of a dedicated nasogastric tube equipped with electrodes and expressed in µV.
Measured: Measurements will be conducted throughout the protocol at each of the 6 PEEP levels tested: 15, 12, 10, 8, 5 and 2 cmH2O. Each PEEP step will last 30 minutes, and measurements will be collected recording the last 10 minutes of each step.
PEEP-induced effects on partitioned respiratory system mechanics
Respiratory mechanics assessed through ventilator and esophageal/gastric manometry, inlcuding end-expiratory, end-inspiratory and driving transpulmonary pressure (expressed in cmH2O).
Measured: Measurements will be conducted throughout the protocol at each of the 6 PEEP levels tested: 15, 12, 10, 8, 5 and 2 cmH2O. Each PEEP step will last 30 minutes, and measurements will be collected recording the last 10 minutes of each step.
PEEP induced effects on tidal volume
Changes in expired tidal volume will be monitored from the ventilator (expressed in mL)
Measured: Measurements will be conducted throughout the protocol at each of the 6 PEEP levels tested: 15, 12, 10, 8, 5 and 2 cmH2O. Each PEEP step will last 30 minutes, and measurements will be collected recording the last 10 minutes of each step.
PEEP-induced effects on end-expiratory lung impedance
End-expiratory lung impedance will be assessed with electrical impedance tomography (EIT) and expressed in arbitrary units and as percentage change from baseline.
Measured: Measurements will be conducted throughout the protocol at each of the 6 PEEP levels tested: 15, 12, 10, 8, 5 and 2 cmH2O. Each PEEP step will last 30 minutes, and measurements will be collected recording the last 10 minutes of each step.
PEEP-induced effects on amount of pendelluft
Pendelluft will be examined through electrical impedance tomography monitoring and expressed as % of total tidal impedance variation.
Measured: Measurements will be conducted throughout the protocol at each of the 6 PEEP levels tested: 15, 12, 10, 8, 5 and 2 cmH2O. Each PEEP step will last 30 minutes, and measurements will be collected recording the last 10 minutes of each step.
PEEP-induced changes in diaphragm thickening fraction assessed through ultrasound
Diaphragm thickening fraction will be assessed and expressed in %, through the formula: (End-inspiratory thickness - End-expiratory thickness) / End-expiratory thickness × 100.
Measured: Measurements will be conducted throughout the protocol at each of the 6 PEEP levels tested: 15, 12, 10, 8, 5 and 2 cmH2O. Each PEEP step will last 30 minutes, and measurements will be collected once within the last 10 minutes of each step.
PEEP-induced effects on internal oblique muscle thickening fraction
Internal oblique muscle thickening fraction will be measured through ultrasound and expressed in %, with the following formula: (End-inspiratory thickness - End-expiratory thickness) / End-expiratory thickness × 100.
Measured: Measurements will be conducted throughout the protocol at each of the 6 PEEP levels tested: 15, 12, 10, 8, 5 and 2 cmH2O. Each PEEP step will last 30 minutes, and measurements will be collected once within the last 10 minutes of each step.
PEEP-induced changes in gastric pressure during expiration
Expiratory muscle activity will be assessed through monitoring of gastric pressure swings during expiration and expressed in cmH2O.
Measured: Measurements will be conducted throughout the protocol at each of the 6 PEEP levels tested: 15, 12, 10, 8, 5 and 2 cmH2O. Each PEEP step will last 30 minutes, and measurements will be collected recording the last 10 minutes of each step.
PEEP-induced changes in abdominal wall muscles expiratory activity
Abdominal wall muscles expiratory activity will be assessed and quantified through the use of surface EMG of the abdominal wall, and expressed in µV.
Measured: Measurements will be conducted throughout the protocol at each of the 6 PEEP levels tested: 15, 12, 10, 8, 5 and 2 cmH2O. Each PEEP step will last 30 minutes, and measurements will be collected recording the last 10 minutes of each step.
PEEP-induced effects on gas exchange
Effects on gas exchange, including PaO2 and PaCO2 monitoring (mmHg), will be evaluated through arterial blood gas monitoring.
Measured: Measurements will be conducted throughout the protocol at baseline and at each of the 6 PEEP levels tested: 15, 12, 10, 8, 5 and 2 cmH2O. Each PEEP step will last 30 minutes, and measurements will be collected once in the last 10 minutes of each step.
PEEP-induced effects on arterial blood pressure
Hemodynamics will be assessed through standard invasive blood pressure and will include the recording of systolic, diastolic and mean arterial blood pressure (mmHg).
Measured: Measurements will be conducted throughout the protocol at baseline and at each of the 6 PEEP levels tested: 15, 12, 10, 8, 5 and 2 cmH2O. Each PEEP step will last 30 minutes, and measurements will be collected once in the last 10 minutes of each step.
PEEP-induced effects on heart rate
Heart rate will be monitored and expressed in beats per minute.
Measured: Measurements will be conducted throughout the protocol at baseline and at each of the 6 PEEP levels tested: 15, 12, 10, 8, 5 and 2 cmH2O. Each PEEP step will last 30 minutes, and measurements will be collected once in the last 10 minutes of each step.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2025
- Study start2 Sep 2025
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDS (Moderate or Severe)Studies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Interventional, prospective physiological study
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Catholic University of the Sacred Heart
- Responsible party
- Sponsor
- Investigators
- Jonne Doorduin, PhD, Principal investigator, Radboud University Medical CenterLeo Heunks, M.D., PhD, Study chair, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07203781
- Sponsor's protocol ID
- NL-009995
- Acronym
- REEF
- Status last verified
- Sep 2025
- First submitted
- 4 Sep 2025
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Unraveling PEEP-induced Effects on Respiratory dRivE and EFfort in Acute Hypoxemic Respiratory Failure: the REEF Study
- ClinicalTrials.gov ID
- NCT07203781
- Acronym / sponsor ID
- REEF / NL-009995
- Keywords
- PEEP, effort, drive, PSV, pressure support ventilation, AHRF, ARDS, diaphragm
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Catholic University of the Sacred Heart
- Study start
- 2 Sep 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 2 Oct 2025 (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.
Rationale:
In patients with acute hypoxemic respiratory failure (AHRF), preserving spontaneous breathing during mechanical ventilation offers physiological benefits, but also carries risks. While spontaneous breathing improves gas exchange and limits diaphragm atrophy, strong inspiratory efforts may worsen lung and diaphragm injury. Balancing these factors requires refined and tailored strategies, such as the modulation of PEEP. However, the impact of PEEP on neural respiratory drive and inspiratory effort is very heterogenous, and these two entities have only been studied separately in limited subsets of patients and healthy subjects. Additionally, it remains unclear whether the major determinant of PEEP-induced changes in respiratory drive and effort is represented by variations in diaphragm geometry, lung compliance, or by the presence of expiratory muscles recruitment, which may counteract its effect.
Objective:
The primary objective is to determine the effect of PEEP on diaphragm neuromechanical efficiency (i.e. an index of neural respiratory drive and inspiratory effort) in patients with acute hypoxemic respiratory failure during invasive assisted mechanical ventilation. The secondary objective is to determine the major physiological contributors to PEEP-mediated changes in diaphragm neuromechanical efficiency.
Study design: Prospective, physiological study. Study population: Invasively mechanically ventilated adult patients admitted to the ICU.
Intervention:
For each patient, six different PEEP levels (15-12-10-8-5-2 cmH2O) will be tested during a decremental PEEP trial. During each step, neural respiratory drive, inspiratory effort, expiratory muscle activity, lung inflation pattern through electrical impedance tomography, respiratory muscle geometry and function through ultrasound and surface EMG, gas exchange and hemodynamics data will be collected.
Main study parameters/endpoints:
The primary outcome of the study will be the evaluation of PEEP-mediated changes in diaphragm neuromechanical efficiency (NME).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Interventional, prospective physiological study
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Other: PEEP level changes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age > 18 years
- Acute hypoxemic respiratory failure (AHRF) with a PaO2/FiO2-ratio ≤ 200
- Patient on invasive assisted mechanical ventilation in pressure support mode exhibiting valid inspiratory efforts (occlusion pressure > 5 cmH2O).
Key exclusion criteria (6 listed)
- Pre-existent neuromuscular disease
- History of chronic respiratory failure requiring long-term oxygen therapy
- Muscle paralysis
- Pneumothorax
- Contra-indication to EIT monitoring (e.g. burns, pacemaker, thoracic wounds limiting electrode placement)
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 |
|---|---|---|
| PEEP level changesFor each patient, six different PEEP levels (15-12-10-8-5-2 cmH2O) will be tested during a decremental PEEP trial. During each step, neural respiratory drive, inspiratory effort, expiratory muscle activity, lung inflation pattern through electrical impedance tomography, respiratory muscle geometry and function through ultrasound and surface EMG, gas exchange and hemodynamics data will be collected. | Other | Single arm |
Primary outcome
PEEP-related changes in diaphragm neuromechanical efficiency (NME)
Time frame: Measurements will be conducted throughout the protocol at each of the 6 PEEP levels tested: 15, 12, 10, 8, 5 and 2 cmH2O. Each PEEP step will last 30 minutes, and measurements will be collected recording the last 10 minutes of each step.
The primary endpoint of this study will be the evaluation of PEEP-induced changes in diaphragm neuromechanical efficiency (NME, cmH2O/µV), calculated as the ratio between the change in transdiaphragmatic pressure (representing inspiratory effort in cmH2O and assessed through the use of esophageal and gastric manometry) and the change in diaphragm electrical activity (neural respiratory drive, expressed in µV and measured through diaphragm EMG by a dedicated nasogastric tube) for each inspiration (ΔPdi/ΔEAdi). NME is an index of diaphragm efficiency and of potential electromechanical uncoupling, a key PEEP-mediated effect on the diaphragm. Its assessment combines changes in neural respiratory drive and inspiratory effort after a change in PEEP, which will be assessed individually and combined as a ratio as primary outcome.
13 secondary outcomes
PEEP-induced changes in inspiratory effort
Time frame: Measurements will be conducted throughout the protocol at each of the 6 PEEP levels tested: 15, 12, 10, 8, 5 and 2 cmH2O. Each PEEP step will last 30 minutes, and measurements will be collected recording the last 10 minutes of each step.
PEEP-induced changes in neural respiratory drive
Time frame: Measurements will be conducted throughout the protocol at each of the 6 PEEP levels tested: 15, 12, 10, 8, 5 and 2 cmH2O. Each PEEP step will last 30 minutes, and measurements will be collected recording the last 10 minutes of each step.
PEEP-induced effects on partitioned respiratory system mechanics
Time frame: Measurements will be conducted throughout the protocol at each of the 6 PEEP levels tested: 15, 12, 10, 8, 5 and 2 cmH2O. Each PEEP step will last 30 minutes, and measurements will be collected recording the last 10 minutes of each step.
PEEP induced effects on tidal volume
Time frame: Measurements will be conducted throughout the protocol at each of the 6 PEEP levels tested: 15, 12, 10, 8, 5 and 2 cmH2O. Each PEEP step will last 30 minutes, and measurements will be collected recording the last 10 minutes of each step.
PEEP-induced effects on end-expiratory lung impedance
Time frame: Measurements will be conducted throughout the protocol at each of the 6 PEEP levels tested: 15, 12, 10, 8, 5 and 2 cmH2O. Each PEEP step will last 30 minutes, and measurements will be collected recording the last 10 minutes of each step.
PEEP-induced effects on amount of pendelluft
Time frame: Measurements will be conducted throughout the protocol at each of the 6 PEEP levels tested: 15, 12, 10, 8, 5 and 2 cmH2O. Each PEEP step will last 30 minutes, and measurements will be collected recording the last 10 minutes of each step.
PEEP-induced changes in diaphragm thickening fraction assessed through ultrasound
Time frame: Measurements will be conducted throughout the protocol at each of the 6 PEEP levels tested: 15, 12, 10, 8, 5 and 2 cmH2O. Each PEEP step will last 30 minutes, and measurements will be collected once within the last 10 minutes of each step.
PEEP-induced effects on internal oblique muscle thickening fraction
Time frame: Measurements will be conducted throughout the protocol at each of the 6 PEEP levels tested: 15, 12, 10, 8, 5 and 2 cmH2O. Each PEEP step will last 30 minutes, and measurements will be collected once within the last 10 minutes of each step.
PEEP-induced changes in gastric pressure during expiration
Time frame: Measurements will be conducted throughout the protocol at each of the 6 PEEP levels tested: 15, 12, 10, 8, 5 and 2 cmH2O. Each PEEP step will last 30 minutes, and measurements will be collected recording the last 10 minutes of each step.
PEEP-induced changes in abdominal wall muscles expiratory activity
Time frame: Measurements will be conducted throughout the protocol at each of the 6 PEEP levels tested: 15, 12, 10, 8, 5 and 2 cmH2O. Each PEEP step will last 30 minutes, and measurements will be collected recording the last 10 minutes of each step.
PEEP-induced effects on gas exchange
Time frame: Measurements will be conducted throughout the protocol at baseline and at each of the 6 PEEP levels tested: 15, 12, 10, 8, 5 and 2 cmH2O. Each PEEP step will last 30 minutes, and measurements will be collected once in the last 10 minutes of each step.
PEEP-induced effects on arterial blood pressure
Time frame: Measurements will be conducted throughout the protocol at baseline and at each of the 6 PEEP levels tested: 15, 12, 10, 8, 5 and 2 cmH2O. Each PEEP step will last 30 minutes, and measurements will be collected once in the last 10 minutes of each step.
PEEP-induced effects on heart rate
Time frame: Measurements will be conducted throughout the protocol at baseline and at each of the 6 PEEP levels tested: 15, 12, 10, 8, 5 and 2 cmH2O. Each PEEP step will last 30 minutes, and measurements will be collected once in the last 10 minutes of each step.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- 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.
Jonne Doorduin, PhD principal investigator
Radboud University Medical Center
Leo Heunks, M.D., PhD study chair
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PEEP level changes in people with ARDS (Moderate or Severe) and Acute Hypoxemic Respiratory Failure, run by Radboud University Medical Center at 1 site 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 6 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: looking for participants now, as of the sponsor's last update on 17 Nov 2025. 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tommaso Rosà, M.D. (06-50155757, tommaso.rosa@radboudumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PEEP-related changes in diaphragm neuromechanical efficiency (NME) (time frame: Measurements will be conducted throughout the protocol at each of the 6 PEEP levels tested: 15, 12, 10, 8, 5 and 2 cmH2O. Each PEEP step will last 30 minutes, and measurements will be collected recording the last 10 minutes of each step.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Nov 2025.