PrematureSCO2TNCT04866342
Servo Controlled Oxygen Targeting (SCO2T) Study: Masimo vs. Nellcor
A study of Premature and Premature Infant, run by University of Edinburgh at 1 site in United Kingdom.
Trial summary
Most premature babies require oxygen therapy. There is uncertainty about what oxygen levels are the best. The oxygen levels in the blood are measured using a monitor called a saturation monitor and the oxygen the baby breathes is adjusted to keep the level in a target range. Read more about this study
- Who is it for?
- Ages 2 days and olderHealthy volunteers can take part
- Conditions the study is for
- Premature, Premature Infant, Oxygen Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 27 Nov 2020to 28 Aug 2023
- 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 2 days and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Infants born at less than 30 weeks gestation
- Infants greater than 48 hours of age
- Infants who are receiving supplementary oxygen
- Person with parental responsibility able to give consent
Who cannot join
- Congenital anomalies that would prevent targeting SpO2 to 90-95% (e.g. cardiac defects)
- Clinical condition of an infant would impair accurateTcPO2 measurement (e.g. impaired perfusion or requirement of inotropic or vasopressor support)
- Parent/person with parental responsibility unable to give informed consent on behalf of the infant
- Infants born less than 22 weeks gestation
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Simpson Centre for Reproductive Health, Royal Infirmary Edinburgh
Edinburgh, City Of Edinburgh, EH16 4SA
About this study
Official title: SCO2T Study: A Randomised Crossover Study Comparing Pulse Oximeter Technology Using Automatic Oxygen Control for Preterm Infants
Most premature babies require oxygen therapy. There is uncertainty about what oxygen levels are the best. The oxygen levels in the blood are measured using a monitor called a saturation monitor and the oxygen the baby breathes is adjusted to keep the level in a target range. Although there is evidence that lower oxygen levels maybe harmful, it is not known how high they need to be for maximum benefit. Very high levels are also harmful. Saturation monitors are not very good for checking for high oxygen levels. For this a different kind of monitor, called a transcutaneous monitor, is better.
Keeping oxygen levels stable is usually done by nurses adjusting the oxygen levels by hand (manual control). There is also equipment available that can do this automatically (servo control). It is not known which is best.
Read more
Research suggests that different automated devices control oxygen effectively as measured by the readings from their internal oxygen saturation monitoring systems. When compared to free-standing saturation monitors there appears to be variations in measured oxygen levels between devices. This could have important clinical implications.
This study aims to show the different achieved oxygen levels when babies are targeted to a set target range. Babies in the study will have both a saturation monitor and a transcutaneous oxygen monitor at the same time. Both types of monitor have been in long term use in neonatal units.
For a period of 12 hours, each baby will have their oxygen adjusted automatically using two different internal oxygen monitoring technologies (6 hours respectively). The investigators will compare the range of oxygen levels that are seen between the two oxygen saturation monitoring technologies.
The investigators will study babies born at less than 30 weeks gestation, who are at least 2 days old, on nasal high flow and still require added oxygen.
Read the detailed description
Presently oxygen is titrated against saturation (SpO2) by manual adjustment. Automated or servo-control systems have been developed that result in tighter control of SpO2 and more time spent in the intended target range. These systems are already in clinical use. Automated systems produce quite large fluctuations in fraction of inspired oxygen (FiO2) in order to keep SpO2 in range. It is possible that this could result in short periods of high or low oxygen tension (PO2) that are undetectable using saturation monitoring. Studies to date have examined the effects of manual and automated (servo) oxygen targeting on SpO2 but not on transcutaneous oxygen tension (TcPO2).
Research suggests that individual servo control devices control oxygen effectively as measured by the readings obtained from their internal SpO2 monitoring system. The device the investigators intend to study is available with two different oximeter monitoring systems. When compared to a separate free-standing SpO2 monitor the devices have a systematic bias in the clinically targeted range. Consequently, this could allow variations between infants in oxygenation large enough to influence important clinical outcome to go unrecognised.
There is a need to determine the achieved SpO2 and TcPO2 distributions associated with the use of different automated control systems as a first step in planning future trials. When this is measured over a small number of hours it is not anticipated that this would have an influence on clinical outcome.
This study is a prospective, single centre, randomised crossover trial of two different internal oximeter monitoring systems in an automated (servo) control device - IntellO2 (Vapotherm, USA) - delivering nasal high flow employing automated oxygen titration. Each infant will act as their own control. Infants born at less than 30 weeks gestation, greater than 48 hour of age and receiving supplementary oxygen will be eligible for inclusion.
The study will be undertaken in the Neonatal Unit at the Simpson Centre for Reproductive Health at the Royal Infirmary of Edinburgh.
Total study time is 12 hours for each infant. Infants will be randomised to commence on either Masimo oximetry or Nellcor oximetry using the Oxygen Assist Module (OAM), IntellO2 Vapotherm device. SpO2 (range 90-95%) will be continuously monitored on a second pulse oximetry probe connected to a bedside multiparameter monitor as per normal standard of care.
Additional monitoring will be carried out as shown below:
- TcPO2 monitoring
- FiO2 monitoring
- Heart rate monitoring (used to validate SpO2 readings)
- Arterial gas sampling (only if conducted by the direct care team as part of the routine care of the infant; no extra blood samples will be taken as part of the study)
FiO2 will be adjusted by the respiratory support device which has integrated automated oxygen control, set to maintain a SpO2 target range of 90-95%.The IntellO2 device uses Precision Flow technology (IntellO2, Vapotherm, USA). By means of a modified closed-loop algorithm, the devise uses MasimoSET or Nellcor pulse oximetry to target a user-set SpO2 value.
SpO2 readings will be downloaded directly from the multiparameter patient monitor. SpO2 will be measured using a Phillips MX500 multiparameter monitor (Phillips, Germany, CE 0366).TcPO2 will be measured using a SenTec Digital Monitoring System with OxiVent sensor (SenTec AG, Switzerland, European patent No. 1535055, CE 0120). Both monitors are routinely used in clinical practice. Transcutaneous data will be recorded contemporaneously and the site of the transcutaneous probe will be rotated on each infant every 2 hours. Control of sensor temperature and application duration are designed to meet all applicable standards and this monitoring device is used routinely in many neonatal units.
- Conditions
- Premature, Premature Infant, Oxygen Therapy, Hypoxia, Hyperoxia, Obstetric Labor, Premature
- Being tested
- Servo control (closed-loop automatic control of the inspiratory fraction of oxygen (FiO2)) - IntellO2 OAM
- Keywords
- Servo Control, Closed-Loop Automated Oxygen Control, Pulse oximeter technology
- Medical subject headings
- Premature Birth, Hypoxia, Hyperoxia, Obstetric Labor, Premature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Servo control (closed-loop automatic control of the inspiratory fraction of oxygen (FiO2)) - IntellO2 OAMDevice
FiO2 adjustments will be made by the IntellO2 Oxygen Assist Module (OAM) for Precision Flow (IntellO2, Vapotherm, USA). By means of a modified closed-loop algorithm, the devise uses MasimoSET or Nellcor pulse oximetry to target a user-set SpO2 value.
Manual adjustments of the inspired oxygen fraction can additionally be made as per standard care.
| Study group | Role | What they receive |
|---|---|---|
| Servo control - Masimo oximetry technology (Oxygen Assist Module, IntellO2, Vapotherm) | Experimental | Automated control of oxygen. The oxygen saturation target range will be set to 90-95% (set to maintain an integral value of 93%) as per standard clinical practice.
Automated oxygen control can be overridden by manual adjustment of oxygen at any time if this is considered necessary to optimise control of oxygenation according to current clinical targets. Receives: Device: Servo control (closed-loop automatic control of the inspiratory fraction of oxygen (FiO2)) - IntellO2 OAM |
| Servo control - Nellcor oximetry technology (Oxygen Assist Module, IntellO2, Vapotherm) | Active comparator | Automated control of oxygen. The oxygen saturation target range will be set to 90-95% (set to maintain an integral value of 93%) as per standard clinical practice.
Automated oxygen control can be overridden by manual adjustment of oxygen at any time if this is considered necessary to optimise control of oxygenation according to current clinical targets. Receives: Device: Servo control (closed-loop automatic control of the inspiratory fraction of oxygen (FiO2)) - IntellO2 OAM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hyperoxia and hypoxia on saturation monitoring
To discover the percentage time spent within target SpO2 range of 90-95% when infants are targeted to an SpO2 range of 90-95% with an automated (servo) control device using two internal oximeter monitoring systems (Masimo and Nellcor).
Measured: 12 hours
Secondary outcomes (9)
Transcutaneous oxygen variability
To discover the percentage time spent within a TcPO2 range of 50mmHg (6.7kPa) - 80mmHg (10.7kPa) when infants are targeted to an SpO2 range of 90-95% with an automated (servo) control device using two internal oximeter monitoring systems (Masimo and Nellcor).
Measured: 12 hours
Saturation variability
To discover the variability in SpO2 (measured by standard deviation) when infants are targeted to an SpO2 range of 90-95% with an automated (servo) control device using two internal oximeter monitoring systems (Masimo and Nellcor).
Measured: 12 hours
Fraction of inspired oxygen variability
To discover the variability in FiO2 (measured by standard deviation) when infants are targeted to an SpO2 range of 90-95% with an automated (servo) control device using two internal oximeter monitoring systems (Masimo and Nellcor).
Measured: 12 hours
Pooled frequency histogram of TcPO2
To generate a pooled frequency histogram of percentage time at a TcPO2 of below 30mmHg, 30-39.9mmHg, 40-49.9mmHg, 50-59.9mmHg, 60-69.9mmHg, 70-79.9mmHg, and 80mmHg and above for infants targeted to an SpO2 range of 90-95% with an automated (servo) control device using two internal oximeter monitoring systems (Masimo and Nellcor).
Measured: 12 hours
Pooled frequency histogram of SpO2
To generate a pooled frequency histogram of percentage time at each SpO2 point between 80 - 100% for infants targeted to an SpO2 range of 90-95% with an automated (servo) control device using two internal oximeter monitoring systems (Masimo and Nellcor).
Measured: 12 hours
Pooled frequency histogram of FiO2
To generate a pooled frequency histogram of the cumulative frequency at a FiO2 of 0.21-0.3, 0.31-0.4, 0.41-0.5, 0.51-0.6, 0.61-0.7, 0.81-0.9 and 0.91-1.0 for infants targeted to an SpO2 range of 90-95% with an automated (servo) control device using two internal oximeter monitoring systems (Masimo and Nellcor).
Measured: 12 hours
Desaturations
To discover the frequency of desaturations for infants targeted to an SpO2 range of 90-95% with an automated (servo) control device using two internal oximeter monitoring systems (Masimo and Nellcor).
Measured: 12 hours
Desaturations
To discover the duration of desaturations for infants targeted to an SpO2 range of 90-95% with an automated (servo) control device using two internal oximeter monitoring systems (Masimo and Nellcor).
Measured: 12 hours
Desaturations
To discover the depth of desaturations and the area (change in PO2 versus time) above and below the set PO2 threshold for infants targeted to an SpO2 range of 90-95% with an automated (servo) control device using two internal oximeter monitoring systems (Masimo and Nellcor).
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2021
- Study start27 Nov 2020
- Primary completion28 Aug 2023
- Study completion28 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PrematureStudies 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
- Crossover
- Model description
- This study is a prospective, single centre, randomised crossover trial of two different internal oximeter monitoring systems in an automated (servo) control device - IntellO2 (Vapotherm, USA) - delivering nasal high flow employing automated oxygen titration. Each infant will act as their own control.
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Lothian
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04866342
- Sponsor's protocol ID
- AC20114
- Acronym
- SCO2T
- Status last verified
- May 2024
- First submitted
- 6 Jan 2021
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SCO2T Study: A Randomised Crossover Study Comparing Pulse Oximeter Technology Using Automatic Oxygen Control for Preterm Infants
- ClinicalTrials.gov ID
- NCT04866342
- Acronym / sponsor ID
- SCO2T / AC20114
- Conditions
- Premature, Premature Infant, Oxygen Therapy, Hypoxia, Hyperoxia, Obstetric Labor, Premature
- Keywords
- Servo Control, Closed-Loop Automated Oxygen Control, Pulse oximeter technology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- NHS Lothian
- Study start
- 27 Nov 2020 (actual)
- Primary completion
- 28 Aug 2023 (actual)
- Study completion
- 28 Aug 2023 (actual)
- First posted
- 29 Apr 2021 (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.
Most premature babies require oxygen therapy. There is uncertainty about what oxygen levels are the best. The oxygen levels in the blood are measured using a monitor called a saturation monitor and the oxygen the baby breathes is adjusted to keep the level in a target range. Although there is evidence that lower oxygen levels maybe harmful, it is not known how high they need to be for maximum benefit. Very high levels are also harmful. Saturation monitors are not very good for checking for high oxygen levels. For this a different kind of monitor, called a transcutaneous monitor, is better.
Keeping oxygen levels stable is usually done by nurses adjusting the oxygen levels by hand (manual control). There is also equipment available that can do this automatically (servo control). It is not known which is best.
Research suggests that different automated devices control oxygen effectively as measured by the readings from their internal oxygen saturation monitoring systems. When compared to free-standing saturation monitors there appears to be variations in measured oxygen levels between devices. This could have important clinical implications.
This study aims to show the different achieved oxygen levels when babies are targeted to a set target range. Babies in the study will have both a saturation monitor and a transcutaneous oxygen monitor at the same time. Both types of monitor have been in long term use in neonatal units.
For a period of 12 hours, each baby will have their oxygen adjusted automatically using two different internal oxygen monitoring technologies (6 hours respectively). The investigators will compare the range of oxygen levels that are seen between the two oxygen saturation monitoring technologies.
The investigators will study babies born at less than 30 weeks gestation, who are at least 2 days old, on nasal high flow and still require added oxygen.
Detailed description
Presently oxygen is titrated against saturation (SpO2) by manual adjustment. Automated or servo-control systems have been developed that result in tighter control of SpO2 and more time spent in the intended target range. These systems are already in clinical use. Automated systems produce quite large fluctuations in fraction of inspired oxygen (FiO2) in order to keep SpO2 in range. It is possible that this could result in short periods of high or low oxygen tension (PO2) that are undetectable using saturation monitoring. Studies to date have examined the effects of manual and automated (servo) oxygen targeting on SpO2 but not on transcutaneous oxygen tension (TcPO2).
Research suggests that individual servo control devices control oxygen effectively as measured by the readings obtained from their internal SpO2 monitoring system. The device the investigators intend to study is available with two different oximeter monitoring systems. When compared to a separate free-standing SpO2 monitor the devices have a systematic bias in the clinically targeted range. Consequently, this could allow variations between infants in oxygenation large enough to influence important clinical outcome to go unrecognised.
There is a need to determine the achieved SpO2 and TcPO2 distributions associated with the use of different automated control systems as a first step in planning future trials. When this is measured over a small number of hours it is not anticipated that this would have an influence on clinical outcome.
This study is a prospective, single centre, randomised crossover trial of two different internal oximeter monitoring systems in an automated (servo) control device - IntellO2 (Vapotherm, USA) - delivering nasal high flow employing automated oxygen titration. Each infant will act as their own control. Infants born at less than 30 weeks gestation, greater than 48 hour of age and receiving supplementary oxygen will be eligible for inclusion.
The study will be undertaken in the Neonatal Unit at the Simpson Centre for Reproductive Health at the Royal Infirmary of Edinburgh.
Total study time is 12 hours for each infant. Infants will be randomised to commence on either Masimo oximetry or Nellcor oximetry using the Oxygen Assist Module (OAM), IntellO2 Vapotherm device. SpO2 (range 90-95%) will be continuously monitored on a second pulse oximetry probe connected to a bedside multiparameter monitor as per normal standard of care.
Additional monitoring will be carried out as shown below:
- TcPO2 monitoring
- FiO2 monitoring
- Heart rate monitoring (used to validate SpO2 readings)
- Arterial gas sampling (only if conducted by the direct care team as part of the routine care of the infant; no extra blood samples will be taken as part of the study)
FiO2 will be adjusted by the respiratory support device which has integrated automated oxygen control, set to maintain a SpO2 target range of 90-95%.The IntellO2 device uses Precision Flow technology (IntellO2, Vapotherm, USA). By means of a modified closed-loop algorithm, the devise uses MasimoSET or Nellcor pulse oximetry to target a user-set SpO2 value.
SpO2 readings will be downloaded directly from the multiparameter patient monitor. SpO2 will be measured using a Phillips MX500 multiparameter monitor (Phillips, Germany, CE 0366).TcPO2 will be measured using a SenTec Digital Monitoring System with OxiVent sensor (SenTec AG, Switzerland, European patent No. 1535055, CE 0120). Both monitors are routinely used in clinical practice. Transcutaneous data will be recorded contemporaneously and the site of the transcutaneous probe will be rotated on each infant every 2 hours. Control of sensor temperature and application duration are designed to meet all applicable standards and this monitoring device is used routinely in many neonatal units.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study is a prospective, single centre, randomised crossover trial of two different internal oximeter monitoring systems in an automated (servo) control device - IntellO2 (Vapotherm, USA) - delivering nasal high flow employing automated oxygen titration. Each infant will act as their own control.
| Arm | Type | Receives |
|---|---|---|
| Servo control - Masimo oximetry technology (Oxygen Assist Module, IntellO2, Vapotherm) | Experimental | Device: Servo control (closed-loop automatic control of the inspiratory fraction of oxygen (FiO2)) - IntellO2 OAMAutomated control of oxygen. The oxygen saturation target range will be set to 90-95% (set to maintain an integral value of 93%) as per standard clinical practice. Automated oxygen control can be overridden by manual adjustment of oxygen at any time if this is considered necessary to optimise control of oxygenation according to current clinical targets. |
| Servo control - Nellcor oximetry technology (Oxygen Assist Module, IntellO2, Vapotherm) | Active comparator | Device: Servo control (closed-loop automatic control of the inspiratory fraction of oxygen (FiO2)) - IntellO2 OAMAutomated control of oxygen. The oxygen saturation target range will be set to 90-95% (set to maintain an integral value of 93%) as per standard clinical practice. Automated oxygen control can be overridden by manual adjustment of oxygen at any time if this is considered necessary to optimise control of oxygenation according to current clinical targets. |
Who may qualify
- Ages
- 2 days and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Infants born at less than 30 weeks gestation
- Infants greater than 48 hours of age
- Infants who are receiving supplementary oxygen
- Person with parental responsibility able to give consent
Key exclusion criteria (4 listed)
- Congenital anomalies that would prevent targeting SpO2 to 90-95% (e.g. cardiac defects)
- Clinical condition of an infant would impair accurateTcPO2 measurement (e.g. impaired perfusion or requirement of inotropic or vasopressor support)
- Parent/person with parental responsibility unable to give informed consent on behalf of the infant
- Infants born less than 22 weeks gestation
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 |
|---|---|---|
| Servo control (closed-loop automatic control of the inspiratory fraction of oxygen (FiO2)) - IntellO2 OAMFiO2 adjustments will be made by the IntellO2 Oxygen Assist Module (OAM) for Precision Flow (IntellO2, Vapotherm, USA). By means of a modified closed-loop algorithm, the devise uses MasimoSET or Nellcor pulse oximetry to target a user-set SpO2 value. Manual adjustments of the inspired oxygen fraction can additionally be made as per standard care. | Device | Servo control - Masimo oximetry technology (Oxygen Assist Module, IntellO2, Vapotherm), Servo control - Nellcor oximetry technology (Oxygen Assist Module, IntellO2, Vapotherm) |
Primary outcome
Incidence of hyperoxia and hypoxia on saturation monitoring
Time frame: 12 hours
To discover the percentage time spent within target SpO2 range of 90-95% when infants are targeted to an SpO2 range of 90-95% with an automated (servo) control device using two internal oximeter monitoring systems (Masimo and Nellcor).
9 secondary outcomes
Transcutaneous oxygen variability
Time frame: 12 hours
Saturation variability
Time frame: 12 hours
Fraction of inspired oxygen variability
Time frame: 12 hours
Pooled frequency histogram of TcPO2
Time frame: 12 hours
Pooled frequency histogram of SpO2
Time frame: 12 hours
Pooled frequency histogram of FiO2
Time frame: 12 hours
Desaturations
Time frame: 12 hours
Desaturations
Time frame: 12 hours
Desaturations
Time frame: 12 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
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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 of Premature and Premature Infant, run by University of Edinburgh at 1 site in United Kingdom.
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 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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?
Incidence of hyperoxia and hypoxia on saturation monitoring (time frame: 12 hours). 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 25 Sep 2024; AzTrials last refreshed its copy on 30 Oct 2026.