Ischemic and Hemorrhagic Stroke, Subarachnoid HemorrhageSETPOINT2NCT02377167
Early Tracheostomy in Ventilated Stroke Patients 2
A study testing Tracheostomy in people with Ischemic and Hemorrhagic Stroke, Subarachnoid Hemorrhage, run by University Hospital Heidelberg at 1 site in Germany.
Trial summary
Patients with severe ischemic and hemorrhagic strokes, who require mechanical ventilation, have a particularly bad prognosis. If they require long-term ventilation, their orotracheal tube needs to be, like in any other intensive care patient, replaced by a shorter tracheal tube below the larynx. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic and Hemorrhagic Stroke, Subarachnoid Hemorrhage
- What is being tested?
- Tracheostomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- 1 siteGermany
- Study dates
- May 2015to Oct 2020
- 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
- Age 18 years or older
- informed consent from legal representative
- non-traumatic cerebrovascular disease
- Estimated ventilation need for at least 2 weeks
- The clinical judgement of the attending neurointensivist
- principle indication for tracheostomy
Who cannot join
- Premorbid modified Rankin Score (mRS)>1
- Artificial ventilation for more than 4 days
- Severe chronic pulmonary disease requiring supplemental oxygen, or evidence of CO2 retention on admission serum analysis (HCO3≥30)
- Severe chronic cardiac disorder
- Any emergency situation compromising the patient's well-being or ability to undergo tracheostomy in the study time-frame
- Intracranial pressure (ICP) persistently > 25cmH2O
Show all 14Show fewer
- Difficult airway management, anticipated problems with extubation / re-intubation,
- Need for a permanent surgical tracheostomy
- Contraindications for a percutaneous tracheostomy (see below)
- High oxygenation requirements: Positive end-expiratory pressure > 12, or fraction of inspired oxygen > 0.6)
- Pregnancy
- Participation in any other interventional trial
- Life expectancy < 3 weeks
- Patient/family unlikely to opt for at least 3 weeks of aggressive therapy prior to consideration of transition to comfort measures/discontinuation of life support measures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Stroke-Related Early Tracheostomy Versus Prolonged Orotracheal Intubation in Neurocritical Care Trial 2
Patients with severe ischemic and hemorrhagic strokes, who require mechanical ventilation, have a particularly bad prognosis. If they require long-term ventilation, their orotracheal tube needs to be, like in any other intensive care patient, replaced by a shorter tracheal tube below the larynx. This so called tracheostomy might be associated with advantages such as less demand of narcotics and pain killers, less lesions in mouth and larynx, better mouth hygiene, safer airway, more patient comfort and earlier mobilisation. The best timepoint for tracheostomy in stroke, however, is not known. Preliminary data from a pilot study of early tracheostomy in patients with hemorrhagic or ischemic stroke suggest that such patients may also have improved survival and long-term functional outcomes, but a large, multicenter clinical trial is needed to confirm these findings.
Read the detailed description
Background: According to United States data from the National Inpatient Sample, about 1.3% of 1.5 million patients (20,300) hospitalized with ischemic stroke from 2007-2009 underwent tracheostomy - while the number of tracheostomies performed for hemorrhagic stroke is unknown. Historically, mechanically ventilated patients with ischemic or hemorrhagic strokes have had poor functional outcomes, and care of such patients is extremely expensive. Effective interventions to improve survival, improve functional recovery, decrease costs, and increase cost-effectiveness are urgently needed. Early tracheostomy of selected medical and surgical patients allows for dramatically decreased sedation and analgesia, and is associated with improved outcomes. Preliminary data from a pilot study of early tracheostomy in patients with hemorrhagic or ischemic stroke suggest that such patients may also have improved survival and long-term functional outcomes, but a large, multicenter clinical trial is needed to confirm these findings.
Method: SETPOINT 2 is a prospective, randomized, controlled, outcome observer-blinded, multicenter, two-armed, comparative trial. Patients are randomized 1:1 to either the experimental group - who undergo percutaneous tracheostomy (PDT) as soon as feasible and within 5 days after intubation ("early tracheostomy") or to the control group ("standard of care" group), in which PDT is performed after day 10 from intubation if the application of an in-house weaning protocol did not lead to successful extubation. Otherwise, no differences in intensive care treatment are intended, and each participating institution's standard operating procedures will be applied to ensure uniform management decisions in fields such as weaning, ventilation, analgesia and sedation, transfusion, and neurological monitoring and management. Blinding to the treatment assignment is impossible for treating physicians, patients and legal representatives as well as for most of the investigators. However, the primary endpoint of long-term outcome and causes of mortality will be assessed by trial-independent adjudicators blinded to the timing of tracheostomy.
The study started as an investigator initiated study which was conducted with limited external funding. Some funding (about 50 000 Euros) was provided from third party funds by the principal investigator and other foundations to provide for data management by the IMBI and other organizational aspects of the study. The principal investigator and the US co-principle investigator-David B. Seder, M.D.) together applied for research funding to several foundations and medical associations and in December 2016 received confirmation of funding from the Patient-Centered Outcomes Research Institute (PCORI). Based on this award, some additional endpoints (e.g. neuromonitoring, patient and family experience) were added as secondary endpoints in this study. The core version of this study remained unchanged. There will be no industry funding of the SETPOINT 2 study. This is not an investigation of any specific medical products or medications.
- Being tested
- Tracheostomy
- Medical subject headings
- Ischemia, Hemorrhagic Stroke, Subarachnoid Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TracheostomyProcedure or surgery
Tracheostomy is performed as percutaneous dilatative tracheostomy with tracheostomy kit by neurointensivists whenever possible. If anatomically or otherwise indicated, surgical tracheostomy is applied.
| Study group | Role | What they receive |
|---|---|---|
| Early Tracheostomy | Experimental | Patients randomized to early tracheostomy receive (preferably dilatative) tracheostomy within 5 days from intubation.
Intervention: Procedure: Early Tracheostomy Receives: Procedure: Tracheostomy |
| Prolonged Intubation | Active comparator | Patients randomized to this arm will be tried to wean off the ventilator and get (an) extubation trial(s) if regarded feasible. In case of failure or non-feasibility, they receive tracheostomy after intubation day 10.
Intervention: Procedure: Late Tracheostomy Receives: Procedure: Tracheostomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional outcome
Dichotomized functional outcome (a modified Rankin Scale (mRS) score of 0-4 (favorable outcome) vs 5,6 (poor outcome)) at 6 months after admission to ICU
Measured: 6 months
Secondary outcomes (13)
Mortality
This secondary endpoint is assessed as time and type of death during the ICU-stay and 6 months after admission.
Measured: 6 months
Hospital Length of stay
This secondary endpoint is assessed as days spent at the recruiting hospital from admission to discharge.
Measured: participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Duration of ventilation
This secondary endpoint is assessed as half-days on the ventilator until the patient is ventilator-independent for 24 h.
Measured: participants will be followed for the duration of hospital stay, an expected average of 5 weeks
Duration and Quality of Weaning
This secondary endpoint is assessed as half-days spent under the possible application of a weaning protocol, and spent within specific phases of such a protocol.
Measured: participants will be followed for the duration of weaning, an expected average of 6 weeks
Time of Analgosedation Dependence
This secondary endpoint is assessed as half-days requiring the application of sedatives and analgesics which are also specified.
Measured: participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Time of ICU dependence
This secondary endpoint is assessed as days from admission to a pre-defined status that would allow discharge from ICU (absence of active infection, vasopressors, pulmonary and cardial instability etc.)
Measured: participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Vasopressor Dependence
This secondary endpoint is assessed as half-days spent under vasopressors during ICU-stay
Measured: participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Number and type of complications
This secondary endpoint is assessed as the number and types of complications arelated to tracheostomy (i.e. bleeding, mispositioning, malfunction, replacement demand,etc.).
Measured: 10 days post tracheostomy
Functional Outcome
This secondary endpoint is assessed as the modified Rankin Scale (mRS) at the above named timepoints.
Measured: admission and discharge
Richmond Agitation Sedation Scale Score
evaluation of consciousness and sedation score
Measured: participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Riker Sedation-Agitation-Score
evaluation of consciousness and sedation score
Measured: participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Burden scale for Family caregivers BSFC-s
assessment of the caregiver burden at the time of discharge from the NCCU and after 6 months
Measured: at discharge and after 6 month
Patient reported outcome questions
assessment of the patient and caregiver burden after 6 month
Measured: after 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2015 (estimated)
- Study startMay 2015
- Primary completionJan 2020
- Study completionOct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Ischemic and Hemorrhagic Stroke, Subarachnoid HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 380 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Heidelberg
- Sponsor type
- University, hospital or other
- Collaborators
- MaineHealth, Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Julian Boesel, University Hospital Heidelberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02377167
- Sponsor's protocol ID
- SETPOINT2
- Acronym
- SETPOINT2
- Status last verified
- Nov 2020
- First submitted
- 28 Jan 2015
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bosel J, Schiller P, Hook Y, Andes M, Neumann JO, Poli S, Amiri H, Schonenberger S, Peng Z, Unterberg A, Hacke W, Steiner T. Stroke-related Early Tracheostomy versus Prolonged Orotracheal Intubation in Neurocritical Care Trial (SETPOINT): a randomized pilot trial. Stroke. 2013 Jan;44(1):21-8. doi: 10.1161/STROKEAHA.112.669895. Epub 2012 Nov 29.
PubMed 23204058Schneider H, Meis J, Klose C, Ratzka P, Niesen WD, Seder DB, Bosel J; SETPOINT2 and IGNITE study groups. Surgical Versus Dilational Tracheostomy in Patients with Severe Stroke: A SETPOINT2 Post hoc Analysis. Neurocrit Care. 2024 Aug;41(1):146-155. doi: 10.1007/s12028-023-01933-9. Epub 2024 Jan 30.
PubMed 38291277Bosel J, Niesen WD, Salih F, Morris NA, Ragland JT, Gough B, Schneider H, Neumann JO, Hwang DY, Kantamneni P, James ML, Freeman WD, Rajajee V, Rao CV, Nair D, Benner L, Meis J, Klose C, Kieser M, Suarez JI, Schonenberger S, Seder DB; SETPOINT2 and the IGNITE Study Groups. Effect of Early vs Standard Approach to Tracheostomy on Functional Outcome at 6 Months Among Patients With Severe Stroke Receiving Mechanical Ventilation: The SETPOINT2 Randomized Clinical Trial. JAMA. 2022 May 17;327(19):1899-1909. doi: 10.1001/jama.2022.4798.
PubMed 35506515Schonenberger S, Niesen WD, Fuhrer H, Bauza C, Klose C, Kieser M, Suarez JI, Seder DB, Bosel J; SETPOINT2-Study Group; IGNITE-Study Group. Early tracheostomy in ventilated stroke patients: Study protocol of the international multicentre randomized trial SETPOINT2 (Stroke-related Early Tracheostomy vs. Prolonged Orotracheal Intubation in Neurocritical care Trial 2). Int J Stroke. 2016 Apr;11(3):368-79. doi: 10.1177/1747493015616638. Epub 2016 Jan 5.
PubMed 26763913
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stroke-Related Early Tracheostomy Versus Prolonged Orotracheal Intubation in Neurocritical Care Trial 2
- ClinicalTrials.gov ID
- NCT02377167
- Acronym / sponsor ID
- SETPOINT2 / SETPOINT2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 380 participants (actual)
- Lead sponsor
- University Hospital HeidelbergUniversity, hospital or other
- Collaborators
- MaineHealth, Patient-Centered Outcomes Research Institute
- Study start
- May 2015 (actual)
- Primary completion
- Jan 2020 (actual)
- Study completion
- Oct 2020 (actual)
- First posted
- 3 Mar 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.
Patients with severe ischemic and hemorrhagic strokes, who require mechanical ventilation, have a particularly bad prognosis. If they require long-term ventilation, their orotracheal tube needs to be, like in any other intensive care patient, replaced by a shorter tracheal tube below the larynx. This so called tracheostomy might be associated with advantages such as less demand of narcotics and pain killers, less lesions in mouth and larynx, better mouth hygiene, safer airway, more patient comfort and earlier mobilisation. The best timepoint for tracheostomy in stroke, however, is not known. Preliminary data from a pilot study of early tracheostomy in patients with hemorrhagic or ischemic stroke suggest that such patients may also have improved survival and long-term functional outcomes, but a large, multicenter clinical trial is needed to confirm these findings.
Detailed description
Background: According to United States data from the National Inpatient Sample, about 1.3% of 1.5 million patients (20,300) hospitalized with ischemic stroke from 2007-2009 underwent tracheostomy - while the number of tracheostomies performed for hemorrhagic stroke is unknown. Historically, mechanically ventilated patients with ischemic or hemorrhagic strokes have had poor functional outcomes, and care of such patients is extremely expensive. Effective interventions to improve survival, improve functional recovery, decrease costs, and increase cost-effectiveness are urgently needed. Early tracheostomy of selected medical and surgical patients allows for dramatically decreased sedation and analgesia, and is associated with improved outcomes. Preliminary data from a pilot study of early tracheostomy in patients with hemorrhagic or ischemic stroke suggest that such patients may also have improved survival and long-term functional outcomes, but a large, multicenter clinical trial is needed to confirm these findings.
Method: SETPOINT 2 is a prospective, randomized, controlled, outcome observer-blinded, multicenter, two-armed, comparative trial. Patients are randomized 1:1 to either the experimental group - who undergo percutaneous tracheostomy (PDT) as soon as feasible and within 5 days after intubation ("early tracheostomy") or to the control group ("standard of care" group), in which PDT is performed after day 10 from intubation if the application of an in-house weaning protocol did not lead to successful extubation. Otherwise, no differences in intensive care treatment are intended, and each participating institution's standard operating procedures will be applied to ensure uniform management decisions in fields such as weaning, ventilation, analgesia and sedation, transfusion, and neurological monitoring and management. Blinding to the treatment assignment is impossible for treating physicians, patients and legal representatives as well as for most of the investigators. However, the primary endpoint of long-term outcome and causes of mortality will be assessed by trial-independent adjudicators blinded to the timing of tracheostomy.
The study started as an investigator initiated study which was conducted with limited external funding. Some funding (about 50 000 Euros) was provided from third party funds by the principal investigator and other foundations to provide for data management by the IMBI and other organizational aspects of the study. The principal investigator and the US co-principle investigator-David B. Seder, M.D.) together applied for research funding to several foundations and medical associations and in December 2016 received confirmation of funding from the Patient-Centered Outcomes Research Institute (PCORI). Based on this award, some additional endpoints (e.g. neuromonitoring, patient and family experience) were added as secondary endpoints in this study. The core version of this study remained unchanged. There will be no industry funding of the SETPOINT 2 study. This is not an investigation of any specific medical products or medications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Tracheostomy | Experimental | Procedure: TracheostomyPatients randomized to early tracheostomy receive (preferably dilatative) tracheostomy within 5 days from intubation. Intervention: Procedure: Early Tracheostomy |
| Prolonged Intubation | Active comparator | Procedure: TracheostomyPatients randomized to this arm will be tried to wean off the ventilator and get (an) extubation trial(s) if regarded feasible. In case of failure or non-feasibility, they receive tracheostomy after intubation day 10. Intervention: Procedure: Late Tracheostomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 years or older
- informed consent from legal representative
- non-traumatic cerebrovascular disease
- Estimated ventilation need for at least 2 weeks
- The clinical judgement of the attending neurointensivist
Key exclusion criteria (14 listed)
- Premorbid modified Rankin Score (mRS)>1
- Artificial ventilation for more than 4 days
- Severe chronic pulmonary disease requiring supplemental oxygen, or evidence of CO2 retention on admission serum analysis (HCO3≥30)
- Severe chronic cardiac disorder
- Any emergency situation compromising the patient's well-being or ability to undergo tracheostomy in the study time-frame
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 |
|---|---|---|
| TracheostomyTracheostomy is performed as percutaneous dilatative tracheostomy with tracheostomy kit by neurointensivists whenever possible. If anatomically or otherwise indicated, surgical tracheostomy is applied. | Procedure or surgery | Early Tracheostomy, Prolonged Intubation |
Primary outcome
Functional outcome
Time frame: 6 months
Dichotomized functional outcome (a modified Rankin Scale (mRS) score of 0-4 (favorable outcome) vs 5,6 (poor outcome)) at 6 months after admission to ICU
13 secondary outcomes
Mortality
Time frame: 6 months
Hospital Length of stay
Time frame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Duration of ventilation
Time frame: participants will be followed for the duration of hospital stay, an expected average of 5 weeks
Duration and Quality of Weaning
Time frame: participants will be followed for the duration of weaning, an expected average of 6 weeks
Time of Analgosedation Dependence
Time frame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Time of ICU dependence
Time frame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Vasopressor Dependence
Time frame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Number and type of complications
Time frame: 10 days post tracheostomy
Functional Outcome
Time frame: admission and discharge
Richmond Agitation Sedation Scale Score
Time frame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Riker Sedation-Agitation-Score
Time frame: participants will be followed for the duration of hospital stay, an expected average of 3 weeks
Burden scale for Family caregivers BSFC-s
Time frame: at discharge and after 6 month
Patient reported outcome questions
Time frame: after 6 month
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 4 Nov 2020.
- Background: PubMed 23204058Bosel J, Schiller P, Hook Y, Andes M, Neumann JO, Poli S, Amiri H, Schonenberger S, Peng Z, Unterberg A, Hacke W, Steiner T. Stroke-related Early Tracheostomy versus Prolonged Orotracheal Intubation in Neurocritical Care Trial (SETPOINT): a randomized pilot trial. Stroke. 2013 Jan;44(1):21-8. doi: 10.1161/STROKEAHA.112.669895. Epub 2012 Nov 29.
- Derived from this study: PubMed 38291277Schneider H, Meis J, Klose C, Ratzka P, Niesen WD, Seder DB, Bosel J; SETPOINT2 and IGNITE study groups. Surgical Versus Dilational Tracheostomy in Patients with Severe Stroke: A SETPOINT2 Post hoc Analysis. Neurocrit Care. 2024 Aug;41(1):146-155. doi: 10.1007/s12028-023-01933-9. Epub 2024 Jan 30.
- Derived from this study: PubMed 35506515Bosel J, Niesen WD, Salih F, Morris NA, Ragland JT, Gough B, Schneider H, Neumann JO, Hwang DY, Kantamneni P, James ML, Freeman WD, Rajajee V, Rao CV, Nair D, Benner L, Meis J, Klose C, Kieser M, Suarez JI, Schonenberger S, Seder DB; SETPOINT2 and the IGNITE Study Groups. Effect of Early vs Standard Approach to Tracheostomy on Functional Outcome at 6 Months Among Patients With Severe Stroke Receiving Mechanical Ventilation: The SETPOINT2 Randomized Clinical Trial. JAMA. 2022 May 17;327(19):1899-1909. doi: 10.1001/jama.2022.4798.
- Derived from this study: PubMed 26763913Schonenberger S, Niesen WD, Fuhrer H, Bauza C, Klose C, Kieser M, Suarez JI, Seder DB, Bosel J; SETPOINT2-Study Group; IGNITE-Study Group. Early tracheostomy in ventilated stroke patients: Study protocol of the international multicentre randomized trial SETPOINT2 (Stroke-related Early Tracheostomy vs. Prolonged Orotracheal Intubation in Neurocritical care Trial 2). Int J Stroke. 2016 Apr;11(3):368-79. doi: 10.1177/1747493015616638. Epub 2016 Jan 5.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tracheostomy in people with Ischemic and Hemorrhagic Stroke, Subarachnoid Hemorrhage, run by University Hospital Heidelberg at 1 site in Germany.
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 6 inclusion and 14 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 4 Nov 2020. 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 Germany. 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?
Functional outcome (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 NCT02377167, which also lists 4 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 4 Nov 2020.