Mechanical PowerweaningNCT06510517
Mechanical Power Versus Diaphragmatic Excursion As a Predictor for Weaning in Chronic Obstructive Pulmonary Disease Patients
An observational study of Mechanical Power, run by Assiut University.
Trial summary
The primary objective is to evaluate the mechanical power as a predictor of weaning of mechanical ventilation in COPD patients hospitalized in the respiratory intensive care unit of Assiut University Hospital. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Mechanical Power
- What is being tested?
- Calculation of Mechanical Power. and Measurement Diaphragmatic Excursion after first SBT
- How many people
- 84 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2024to 1 Aug 2026
- How long will I take part?
- 8 Weeks
- Phase
- Observational
- 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 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: COPD patients who are mechanically ventilated in Respiratory ICU of Assiut University Hospital
Who may be able to join
- All COPD patients who are mechanically ventilated patients. Must be eligible for weaning according to European respiratory society 2016.
Who cannot join
- Patients with Bronchiectasis, interstitial lung diseases, lung scarring.
- Tracheostomized patients.
Trial locations and contacts
No sites are listed yet.
Mohamed Mamdouh Awad, Master Degree of Chest Diseses contact
About this study
Official title: Mechanical Power Versus Diaphragmatic Excursion As a Predictor for Weaning in Chronic Obstructive Pulmonary Disease Patients: Prospective Cohort Study
The primary objective is to evaluate the mechanical power as a predictor of weaning of mechanical ventilation in COPD patients hospitalized in the respiratory intensive care unit of Assiut University Hospital.
The secondary objective is to compare between mechanical power and diaphragmatic excursion (DE) assessed by ultrasound as a predictor of weaning in these patients. Also, to investigate the association between MP and DE and mortality in these patients
Read the detailed description
Acute exacerbation of chronic obstructive pulmonary disease (AECOPD), a public health problem that is characterized by persistent airflow limitation ,it develops when there is a significant exposure of irritants causing an inflammatory response in the lungs, it is a common cause of respiratory failure which require hospital admission that is associated with increased medical costs.
The World Health Organization reported that COPD was the fifth most common disease globally in 2020, with a prevalence of 7.8-19.7% in adults. Approximately, 60% of patients with COPD admitted with hypercapnic respiratory failure.
Acute exacerbations of chronic obstructive pulmonary disease (COPD) is characterized by acute worsening of respiratory symptoms associated with the development of severe airflow limitation, gas trapping, dynamic hyperinflation and intrinsic positive end-expiratory pressure (PEEPi). In the most severe cases, these exacerbations may cause acute respiratory failure, which may require mechanical ventilation.
The process of weaning from mechanical ventilation remains one of the most critical challenges in patients underwent mechanical ventilation in the intensive care unit (ICU). The multidisciplinary team must study the optimal time for weaning from the mechanical ventilator as premature weaning may lead to weaning failure and thus increase the risk of hospital acquired infections, costs of care, length of ICU stay, Morbidity and Mortality.
Current guidelines recommend several indices applied at the bedside to predict successful weaning from mechanical ventilation. A spontaneous breathing trial (SBT) is an appropriate way to prepare the patient for extubation; however, even after successful SBT, failure rates and subsequent reintubation can exceed 20% in the highest-risk patient.
Mechanical power (MP) is the energy delivered by the ventilator to the entire respiratory system per time unit and combines all factors affecting the energy load of the respiratory system, including pressure, tidal volume, flow rate and respiratory rate.
MP is primarily calculated as the product of the applied airway pressure and minute ventilation and can be used as an estimate of the workload exerted on the respiratory muscles during spontaneous breathing.
MP is a major determinant to ensure adequate gas exchange in the body and a key factor in assessing the ability of a patient to successfully wean from mechanical ventilation.
Therefore, a larger scale clinical study is needed to further verify the relationship between MP and weaning outcomes in all critically ill mechanically ventilated patients.
- Conditions
- Mechanical Power
- Being tested
- Calculation of Mechanical Power., Measurement Diaphragmatic Excursion after first SBT
- Keywords
- Mechanical power, Weaning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calculation of Mechanical Power.Other
Total respiratory rate (RR). Positive end-expiratory pressure (PEEP) (the external or applied PEEP) recorded, not the total PEEP, or intrinsic PEEP. The plateau pressure (Pplat) was measured during an inspiratory pause on the ventilator. Peak inspiratory pressure (Ppeak) should be obtained while the patient is relaxed, not coughing or moving in bed. MP was calculated according to Gattinoni's simplified mechanical power equation as follows (3,8):
MP(J/min)=0.098×VT×RR×(Ppeak-0.5×ΔP).
Measurement Diaphragmatic Excursion after first SBTOther
Chest ultrasound to assess diaphragmatic excursion (DE(. M-mode was used to record the movement of the diaphragm during tidal breathing when the sampling line and diaphragm were as vertical as possible (not < 70°). The data was measured from the first respiratory cycle at 0 min after SBT. The DE at 0 min, 5 min, and 30 min of SBT was respectively named as DE0, DE5, and DE30. The variation of right DE between each time point was named as ΔDE30-5 and ΔDE30-0. (7)
| Study group | Role | What they receive |
|---|---|---|
| Paients with Successful weaning | The procedure of weaning from mechanical ventilation will be considered as early as possible. Patients who will be mechanically ventilated >24 h will be underwent daily screen of subjective and objective indices for assessment of readiness to wean. Weaning will be conducted according to European Respiratory Society guidelines (ERS) (5).
The criteria for successful extubation: successful extubation was defined as the ability to maintain spontaneous breathing for at least 48 h, without any ventilatory support. Receives: Other: Calculation of Mechanical Power.; Other: Measurement Diaphragmatic Excursion after first SBT | |
| Patients with failed weaning | the reconnection to ventilator (invasive or noninvasive) within 48 h due to respiratory failure or other reasons. Extubation and the reconnection to ventilator were all based on SBT results and physicians' decision (5,9). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Calculation of Mechanical Power before first trial of extubation.
Calculation of Mechanical Power before first trial of extubation for every mechanically ventilated patient before first trial of extubation.
Measured: 30 days
Secondary outcomes (4)
value of Mechanical Power in died patients.
Mechanical Power as a predictor of patient's mortality.
Measured: 30 days
calculation of Mechanical Power in every Patients suffered from ventilator induced lung injury.
calculation of Mechanical Power and the number of Patients suffered from ventilator induced lung injury so study association between value of MP and possibility of VILI to be occurred.
Measured: 30 days
Calculation of other parameters of weaning as Respiratory rate, Rapid shallow breathing index and expiratory tidal volume.
Correlation analysis between mechanical power and other parameters of weaning in evaluation of prognosis in COPD patients.
Measured: 30 days
number of days for hospital stay and ICU stay for every Mechanically ventilated patients.
calculation of mechanical power and duration of hospital stay and ICU stay for each patient.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2024
- Study start1 Dec 2024 (estimated)
- Primary completion1 Aug 2026 (estimated)
- Study completion1 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Mechanical PowerStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 84 participants (estimated)
- Target duration
- 8 Weeks
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Mamdouh Moustafa, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06510517
- Sponsor's protocol ID
- Mechanical Power in Weaning
- Acronym
- weaning
- Status last verified
- Jul 2024
- First submitted
- 28 Jun 2024
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yu J, Lee MR, Chen CT, Lin YT, How CK. Predictors of Successful Weaning from Noninvasive Ventilation in Patients with Acute Exacerbation of Chronic Obstructive Pulmonary Disease: A Single-Center Retrospective Cohort Study. Lung. 2021 Oct;199(5):457-466. doi: 10.1007/s00408-021-00469-z. Epub 2021 Aug 21.
PubMed 34420091Mohamed-Hussein AAR, Makhlouf HA, Selim ZI, Gamaleldin Saleh W. Association between hand grip strength with weaning and intensive care outcomes in COPD patients: A pilot study. Clin Respir J. 2018 Oct;12(10):2475-2479. doi: 10.1111/crj.12921. Epub 2018 Sep 23.
PubMed 29931773Yan Y, Xie Y, Chen X, Sun Y, Du Z, Wang Y, Li X. Mechanical power is associated with weaning outcome in critically ill mechanically ventilated patients. Sci Rep. 2022 Nov 16;12(1):19634. doi: 10.1038/s41598-022-21609-2.
PubMed 36385129Azizi BA, Munoz-Acuna R, Suleiman A, Ahrens E, Redaelli S, Tartler TM, Chen G, Jung B, Talmor D, Baedorf-Kassis EN, Schaefer MS. Mechanical power and 30-day mortality in mechanically ventilated, critically ill patients with and without Coronavirus Disease-2019: a hospital registry study. J Intensive Care. 2023 Apr 6;11(1):14. doi: 10.1186/s40560-023-00662-7.
PubMed 37024938Boles JM, Bion J, Connors A, Herridge M, Marsh B, Melot C, Pearl R, Silverman H, Stanchina M, Vieillard-Baron A, Welte T. Weaning from mechanical ventilation. Eur Respir J. 2007 May;29(5):1033-56. doi: 10.1183/09031936.00010206.
PubMed 17470624Leonov Y, Kisil I, Perlov A, Stoichev V, Ginzburg Y, Nazarenko A, Gimelfarb Y. Predictors of successful weaning in patients requiring extremely prolonged mechanical ventilation. Adv Respir Med. 2020;88(6):477-484. doi: 10.5603/ARM.a2020.0151.
PubMed 33393639Zhang X, Yuan J, Zhan Y, Wu J, Liu B, Zhang P, Yu T, Wang Z, Jiang X, Lu W. Evaluation of diaphragm ultrasound in predicting extubation outcome in mechanically ventilated patients with COPD. Ir J Med Sci. 2020 May;189(2):661-668. doi: 10.1007/s11845-019-02117-1. Epub 2019 Nov 6.
PubMed 31691888Paudel R, Trinkle CA, Waters CM, Robinson LE, Cassity E, Sturgill JL, Broaddus R, Morris PE. Mechanical Power: A New Concept in Mechanical Ventilation. Am J Med Sci. 2021 Dec;362(6):537-545. doi: 10.1016/j.amjms.2021.09.004. Epub 2021 Sep 28.
PubMed 34597688Akella P, Voigt LP, Chawla S. To Wean or Not to Wean: A Practical Patient Focused Guide to Ventilator Weaning. J Intensive Care Med. 2022 Nov;37(11):1417-1425. doi: 10.1177/08850666221095436. Epub 2022 Jul 11.
PubMed 35815895
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanical Power Versus Diaphragmatic Excursion As a Predictor for Weaning in Chronic Obstructive Pulmonary Disease Patients: Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06510517
- Acronym / sponsor ID
- weaning / Mechanical Power in Weaning
- Conditions
- Mechanical Power
- Keywords
- Mechanical power, Weaning
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 1 Aug 2026 (estimated)
- First posted
- 19 Jul 2024 (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.
The primary objective is to evaluate the mechanical power as a predictor of weaning of mechanical ventilation in COPD patients hospitalized in the respiratory intensive care unit of Assiut University Hospital.
The secondary objective is to compare between mechanical power and diaphragmatic excursion (DE) assessed by ultrasound as a predictor of weaning in these patients. Also, to investigate the association between MP and DE and mortality in these patients
Detailed description
Acute exacerbation of chronic obstructive pulmonary disease (AECOPD), a public health problem that is characterized by persistent airflow limitation ,it develops when there is a significant exposure of irritants causing an inflammatory response in the lungs, it is a common cause of respiratory failure which require hospital admission that is associated with increased medical costs.
The World Health Organization reported that COPD was the fifth most common disease globally in 2020, with a prevalence of 7.8-19.7% in adults. Approximately, 60% of patients with COPD admitted with hypercapnic respiratory failure.
Acute exacerbations of chronic obstructive pulmonary disease (COPD) is characterized by acute worsening of respiratory symptoms associated with the development of severe airflow limitation, gas trapping, dynamic hyperinflation and intrinsic positive end-expiratory pressure (PEEPi). In the most severe cases, these exacerbations may cause acute respiratory failure, which may require mechanical ventilation.
The process of weaning from mechanical ventilation remains one of the most critical challenges in patients underwent mechanical ventilation in the intensive care unit (ICU). The multidisciplinary team must study the optimal time for weaning from the mechanical ventilator as premature weaning may lead to weaning failure and thus increase the risk of hospital acquired infections, costs of care, length of ICU stay, Morbidity and Mortality.
Current guidelines recommend several indices applied at the bedside to predict successful weaning from mechanical ventilation. A spontaneous breathing trial (SBT) is an appropriate way to prepare the patient for extubation; however, even after successful SBT, failure rates and subsequent reintubation can exceed 20% in the highest-risk patient.
Mechanical power (MP) is the energy delivered by the ventilator to the entire respiratory system per time unit and combines all factors affecting the energy load of the respiratory system, including pressure, tidal volume, flow rate and respiratory rate.
MP is primarily calculated as the product of the applied airway pressure and minute ventilation and can be used as an estimate of the workload exerted on the respiratory muscles during spontaneous breathing.
MP is a major determinant to ensure adequate gas exchange in the body and a key factor in assessing the ability of a patient to successfully wean from mechanical ventilation.
Therefore, a larger scale clinical study is needed to further verify the relationship between MP and weaning outcomes in all critically ill mechanically ventilated patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 8 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paients with Successful weaning | – | Other: Calculation of Mechanical Power., Other: Measurement Diaphragmatic Excursion after first SBTThe procedure of weaning from mechanical ventilation will be considered as early as possible. Patients who will be mechanically ventilated >24 h will be underwent daily screen of subjective and objective indices for assessment of readiness to wean. Weaning will be conducted according to European Respiratory Society guidelines (ERS) (5). The criteria for successful extubation: successful extubation was defined as the ability to maintain spontaneous breathing for at least 48 h, without any ventilatory support. |
| Patients with failed weaning | – | –the reconnection to ventilator (invasive or noninvasive) within 48 h due to respiratory failure or other reasons. Extubation and the reconnection to ventilator were all based on SBT results and physicians' decision (5,9). |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- COPD patients who are mechanically ventilated in Respiratory ICU of Assiut University Hospital
Key inclusion criteria (1 listed)
- All COPD patients who are mechanically ventilated patients. Must be eligible for weaning according to European respiratory society 2016.
Key exclusion criteria (2 listed)
- Patients with Bronchiectasis, interstitial lung diseases, lung scarring.
- Tracheostomized patients.
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 |
|---|---|---|
| Calculation of Mechanical Power.Total respiratory rate (RR). Positive end-expiratory pressure (PEEP) (the external or applied PEEP) recorded, not the total PEEP, or intrinsic PEEP. The plateau pressure (Pplat) was measured during an inspiratory pause on the ventilator. Peak inspiratory pressure (Ppeak) should be obtained while the patient is relaxed, not coughing or moving in bed. MP was calculated according to Gattinoni's simplified mechanical power equation as follows (3,8): MP(J/min)=0.098×VT×RR×(Ppeak-0.5×ΔP). | Other | Paients with Successful weaning |
| Measurement Diaphragmatic Excursion after first SBTChest ultrasound to assess diaphragmatic excursion (DE(. M-mode was used to record the movement of the diaphragm during tidal breathing when the sampling line and diaphragm were as vertical as possible (not < 70°). The data was measured from the first respiratory cycle at 0 min after SBT. The DE at 0 min, 5 min, and 30 min of SBT was respectively named as DE0, DE5, and DE30. The variation of right DE between each time point was named as ΔDE30-5 and ΔDE30-0. (7) | Other | Paients with Successful weaning |
Primary outcome
Calculation of Mechanical Power before first trial of extubation.
Time frame: 30 days
Calculation of Mechanical Power before first trial of extubation for every mechanically ventilated patient before first trial of extubation.
4 secondary outcomes
value of Mechanical Power in died patients.
Time frame: 30 days
calculation of Mechanical Power in every Patients suffered from ventilator induced lung injury.
Time frame: 30 days
Calculation of other parameters of weaning as Respiratory rate, Rapid shallow breathing index and expiratory tidal volume.
Time frame: 30 days
number of days for hospital stay and ICU stay for every Mechanically ventilated patients.
Time frame: 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
- Background: PubMed 34420091Yu J, Lee MR, Chen CT, Lin YT, How CK. Predictors of Successful Weaning from Noninvasive Ventilation in Patients with Acute Exacerbation of Chronic Obstructive Pulmonary Disease: A Single-Center Retrospective Cohort Study. Lung. 2021 Oct;199(5):457-466. doi: 10.1007/s00408-021-00469-z. Epub 2021 Aug 21.
- Background: PubMed 29931773Mohamed-Hussein AAR, Makhlouf HA, Selim ZI, Gamaleldin Saleh W. Association between hand grip strength with weaning and intensive care outcomes in COPD patients: A pilot study. Clin Respir J. 2018 Oct;12(10):2475-2479. doi: 10.1111/crj.12921. Epub 2018 Sep 23.
- Background: PubMed 36385129Yan Y, Xie Y, Chen X, Sun Y, Du Z, Wang Y, Li X. Mechanical power is associated with weaning outcome in critically ill mechanically ventilated patients. Sci Rep. 2022 Nov 16;12(1):19634. doi: 10.1038/s41598-022-21609-2.
- Background: PubMed 37024938Azizi BA, Munoz-Acuna R, Suleiman A, Ahrens E, Redaelli S, Tartler TM, Chen G, Jung B, Talmor D, Baedorf-Kassis EN, Schaefer MS. Mechanical power and 30-day mortality in mechanically ventilated, critically ill patients with and without Coronavirus Disease-2019: a hospital registry study. J Intensive Care. 2023 Apr 6;11(1):14. doi: 10.1186/s40560-023-00662-7.
- Background: PubMed 17470624Boles JM, Bion J, Connors A, Herridge M, Marsh B, Melot C, Pearl R, Silverman H, Stanchina M, Vieillard-Baron A, Welte T. Weaning from mechanical ventilation. Eur Respir J. 2007 May;29(5):1033-56. doi: 10.1183/09031936.00010206.
- Background: PubMed 33393639Leonov Y, Kisil I, Perlov A, Stoichev V, Ginzburg Y, Nazarenko A, Gimelfarb Y. Predictors of successful weaning in patients requiring extremely prolonged mechanical ventilation. Adv Respir Med. 2020;88(6):477-484. doi: 10.5603/ARM.a2020.0151.
- Background: PubMed 31691888Zhang X, Yuan J, Zhan Y, Wu J, Liu B, Zhang P, Yu T, Wang Z, Jiang X, Lu W. Evaluation of diaphragm ultrasound in predicting extubation outcome in mechanically ventilated patients with COPD. Ir J Med Sci. 2020 May;189(2):661-668. doi: 10.1007/s11845-019-02117-1. Epub 2019 Nov 6.
- Background: PubMed 34597688Paudel R, Trinkle CA, Waters CM, Robinson LE, Cassity E, Sturgill JL, Broaddus R, Morris PE. Mechanical Power: A New Concept in Mechanical Ventilation. Am J Med Sci. 2021 Dec;362(6):537-545. doi: 10.1016/j.amjms.2021.09.004. Epub 2021 Sep 28.
- Background: PubMed 35815895Akella P, Voigt LP, Chawla S. To Wean or Not to Wean: A Practical Patient Focused Guide to Ventilator Weaning. J Intensive Care Med. 2022 Nov;37(11):1417-1425. doi: 10.1177/08850666221095436. Epub 2022 Jul 11.
Related trials for Mechanical Power
Not yet recruitingObservational study
Effects of Trendelenburg Position and Pneumoperitoneum on Mechanical Power and Respiratory Mechanics During V-NOTES Surgery
Vnotes, Respiratory Mechanics
Not yet recruiting
Flow-Controlled Ventilation to Improve Postoperative Pulmonary Outcome After Thoracic Surgery
Mechanical Ventilation, Postoperative Pulmonary Complications (PPCs)
RecruitingObservational study
Pulmonary Mechanics and Cerebral Oxygenation During Prone Lumbar Disc Surgery
Lumbar Disc Herniation, Respiratory Mechanics
Not yet recruitingObservational study
Comparison of Different Ventilation Modes in Video-Assisted Thoracoscopic Lung Resection
One-lung Ventilation (OLV), Video-assisted Thoracis Surgery (VATS)
Enrolling by invitationObservational study
Application Study of Individualized Mechanical Power Titration Strategy Based on PiCCO (Pulse Index Continuous Cardiac Output) Monitoring Parameters in ARDS Patients
Acute Respiratory Distress Syndrome
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.
Mohamed Mamdouh Awad, Master Degree of Chest Diseses contact
Questions about this trial
What is this clinical trial studying?
An observational study of Mechanical Power, run by Assiut University.
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 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Mamdouh Awad, Master Degree of Chest Diseses (2001023420225, mohamedmamdouh15794@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Calculation of Mechanical Power before first trial of extubation. (time frame: 30 days). 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 NCT06510517, which also lists 9 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 3 Dec 2024.