Infant, PrematureMODERATION NeoNCT05030012
Maintaining Optimal HVNI Delivery Using Automatic Titration of Oxygen in Preterm Infants
A study of Infant, Premature and Neonatal Respiratory Distress, run by Vapotherm, Inc. at 3 sites in United States.
Trial summary
Oxygen treatment is common in management of preterm babies requiring intensive care. Delivery of too much or too little oxygen increase the risk of damage to eyes and lungs, and contributes to death and disability. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Infant, Premature, Neonatal Respiratory Distress, Oxygen Saturation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 3 sitesUnited States
- Study dates
- 2 Sep 2021to 19 Oct 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Infants delivered at a gestational age of less than or equal to 35 6/7 weeks (Preterm) being treated with high velocity nasal insufflation therapy for the management of respiratory distress syndrome
- Patients that clinically require SpO2 maintenance within the target range of 90-95%
- A need for supplemental oxygen as demonstrated by a required FiO2 > 0.25 at enrollment
- Requiring a flow rate of greater than 2 L•min-1 such that the assumed inspired oxygen fraction matched delivered oxygen fraction (definition of HVNI).
- A minimum of 6 manual FiO2 adjustments in the 24hr period prior to trial enrollment.
- Willing/Able to complete informed consent.
Who cannot join
- Current patient weight of <1000g or >3500g at time of study
- Major congenital abnormalities
- Hemodynamic instability, defined as being outside of a normotensive range based on an infant's individual characteristics by clinician
- Persistent unresolved apnea defined as: requiring 6 stimulations or more per 6 hours
- Seizures
- Ongoing sepsis
- Meningitis
- Clinician's concern regarding stability of the infant
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Utah Hospital
Salt Lake City, Utah, 84132
Seattle Children's Hospital
Seattle, Washington, 98195
Children's National Hospital & Research Institute
Washington D.C., District of Columbia, 20010
About this study
Official title: Maintaining Optimal Delivery Using Automatic Titration of Oxygen in Preterm Infants Receiving High Velocity Nasal Insufflation Therapy
Oxygen treatment is common in management of preterm babies requiring intensive care. Delivery of too much or too little oxygen increase the risk of damage to eyes and lungs, and contributes to death and disability. Oxygen control in preterm infants requires frequent adjustments in the amount of oxygen delivered to the baby. This is generally performed manually by a clinician attending the baby, and generally directed to maintaining a specific range of blood oxygen saturation. The manual control often results in only half of the time in the specified range, with the baby experiencing high and low blood oxygen saturations.
The technology being studied is designed to assist the clinician in maintaining blood oxygen saturation within target range by measuring oxygen saturation and automatically adjusting the amount of oxygen delivered for babies receiving high velocity nasal insufflation (an advanced form of high flow oxygen therapy). The proposed study will evaluate the efficacy and safety of the automatic control of oxygen by the new technology, as compared to manual control, among babies receiving high velocity therapy in a neonatal intensive care unit.
Read the detailed description
Detailed Description: Supplemental oxygen is commonly administered to babies in neonatal intensive care units. The goal of oxygen therapy is to maintain normal oxygenation while minimizing hypoxemia and hypoxemia. Preterm infants are particularly vulnerable to oxygen toxicity and oxidative stress leading to retinopathy of prematurity (ROP), bronchopulmonary dysplasia (BPD), and periventricular leukomalacia (PVL). It's also well known that preterm infants experience hypoxic events exposing the baby to low oxygen levels. These hypoxic events vary as the infant matures, but exposure to prolonged and frequent episodes of hypoxemia is associated with increased morbidity and mortality. The delivery of oxygen is generally controlled by a clinician, and the control decisions are generally made using a non-invasive measure of blood oxygen saturation called pulse oximetry (SpO2) and is a standard of care in the neonatal intensive care unit. The most frequent item adjusted by clinicians to maintain SpO2 within specific target ranges is the fraction of the inspired oxygen (FiO2).
In a recent study by Reynolds, et al., caregiver manual control of oxygen delivered to NICU babies receiving high velocity therapy resulted in only 49% of the total 24-hour study period with the babies within the target SpO2 range (90-95%). by the caregiver based on the monitored oxygen saturation. Similar to the Reynolds findings, Hagadorn et al., conducted a study in 14 centers and showed that preterm infants under 28 weeks' gestation receiving oxygen spent on average only 48% of the time with SpO2 within the prescribed target range, about 36% of the time above and 16% of the time with SpO2 below the target range.
Preterm infants have frequent fluctuations in SpO2 due to their cardio-respiratory instability requiring frequent adjustments of FiO2 . Consequently, these particularly vulnerable infants spend significant time with SpO2 outside the optimal target range and are often exposed to extremes of hypoxemia and hyperoxaemia. The automatic oxygen control system continuously monitors the oxygen saturation and adjusts the oxygen delivery to maintain oxygen saturation within the target range. The efficacy of this mode of oxygen control was demonstrated by Reynolds, et al. in 2018 from two centers in the United Kingdom. Automated control of FiO2 can significantly improve compliance of oxygen saturation targeting and may significantly reduces exposure to hypoxemia as well as hyperoxaemia. The high velocity nasal insufflation therapy is a common mode of non-invasive respiratory support in preterm infants.
Unlike prior studies, this study will include a set of hypothesis-driven safety endpoints (proportion of time above or below target range), stratification by body mass at enrolment, and skin pigmentation phenotype. The objective of this randomized control trial is to evaluate the efficacy of the controller (Vapotherm Oxygen Assist Module [OAM]) in maintaining the SpO2 within target range for premature infants receiving high velocity therapy and presenting with a labile FiO2 requirement.
- Conditions
- Infant, Premature, Neonatal Respiratory Distress, Oxygen Saturation, Bronchopulmonary Dysplasia
- Being tested
- Automated Control, Manual Control
- Keywords
- High Velocity Nasal Insufflation (HVNI), Preterm Infants, Noninvasive Ventilatory Support, Automatic Oxygen Titration, Closed Loop Oxygen Control, High Flow Nasal Cannula
- Medical subject headings
- Premature Birth, Pulmonary Atelectasis, Bronchopulmonary Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Automated ControlDevice
Also called Oxygen Assist Module (OAM), Vapotherm OAM + Vapotherm Precision Flow
The purpose of this intervention is to evaluate that the efficacy and safety during the automated performance of the Vapotherm OAM are not inferior to standard care practice (manual control) in maintaining SpO2 levels of 90-95% in preterm infants requiring oxygen adjustments while being treated with high velocity nasal insufflation (HVNI) therapy.
Manual ControlDevice
Also called Vapotherm Precision Flow, Treatment as Usual (TAU), Standard of Care (SOC)
The purpose of this intervention is to establish an active comparator via standard care practice against which to evaluate the efficacy and safety of the automated arm of the study, for determination of non-inferiority of that automated control arm to manual control in maintaining SpO2 levels of 90-95% in preterm infants being treated with high velocity nasal insufflation (HVNI) therapy.
| Study group | Role | What they receive |
|---|---|---|
| Automated Control (OAM) | Experimental | In this arm, FiO2 levels delivered via high-velocity nasal insufflation therapy (Vapotherm Precision Flow) will be adjusted by the Oxygen Assist Module (OAM) to keep the infants pulse oxygen saturation within a target range (90-95%). Clinical staff will have the ability to override FiO2 levels when required, and instructed to do so. Receives: Device: Automated Control |
| Manual Control (Manual) | Active comparator | In this arm, FiO2 levels delivered via high-velocity nasal insufflation therapy (Vapotherm Precision Flow) will be manually adjusted by clinical staff to keep infants' oxygen saturation between 90-95%. Receives: Device: Manual Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety Objective - Percentage of Time Outside of SpO2 Target Range
Percentage of time spent outside target oxygen saturation range, measured by pulse oximetry (SpO2). A lower value indicates a better outcome.
Measured: Through study completion, two consecutive 24-hour periods
Primary Performance Objective - Percentage of Time Within SpO2 Target Range
Percentage of time spent within target oxygen saturation range, measured by pulse oximetry (SpO2). A higher value indicates a better outcome.
Measured: Through study completion, two consecutive 24-hour periods
Secondary outcomes (2)
Performance Endpoint, Percentage of Time IN Range (SpO2 in 90-95% With FiO2 Special at .21) Across the Two Weight Groups.
Percentage of time spent within target oxygen saturation range across two weight groups (1000g-2500g, 2501g-3500g), measured by pulse oximetry (SpO2). A higher value indicates a better outcome.
Measured: Through study completion, two consecutive 24-hour periods
Secondary Performance Objective 2 - Percentage of Time Within SpO2 Target Range (Skin Pigmentation)
Percentage of time spent within target oxygen saturation range across two skin pigmentation groups (light, dark), measured by pulse oximetry (SpO2). A higher value indicates a better outcome.
Measured: Through study completion, two consecutive 24-hour periods
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2021
- Study start2 Sep 2021
- Primary completion19 Oct 2023
- Study completion19 Oct 2023
Why it stopped: No path to obtain FDA approval for the legacy Precision Flow OAM.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Infant, 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 will be a prospective, multi-center, randomized, crossover trial evaluating automated oxygen titration versus manual titration in maintaining oxygen saturation levels in preterm infants requiring noninvasive ventilatory support via high velocity nasal insufflation (HVNI).
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vapotherm, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Children's National Research Institute, Seattle Children's Hospital, University of Utah
- Responsible party
- Sponsor
- Investigators
- Billie L Short, MD, Principal investigator, Children's National Research InstituteKhodayar Rais-Bahrami, MD, Principal investigator, Children's National Research InstituteRobert J DiGeronimo, MD, Principal investigator, Seattle Children's HospitalRobert DiBlasi, RRT-NPS, Principal investigator, Seattle Children's HospitalBradley A Yoder, MD, Principal investigator, University of Utah Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05030012
- Sponsor's protocol ID
- RP-NIOA2019001Reg
- Acronym
- MODERATION Neo
- Status last verified
- Jun 2024
- First submitted
- 25 Aug 2021
- Last updated
- 26 Jun 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Reynolds PR, Miller TL, Volakis LI, Holland N, Dungan GC, Roehr CC, Ives K. Randomised cross-over study of automated oxygen control for preterm infants receiving nasal high flow. Arch Dis Child Fetal Neonatal Ed. 2019 Jul;104(4):F366-F371. doi: 10.1136/archdischild-2018-315342. Epub 2018 Nov 21.
PubMed 30464005Hagadorn JI, Furey AM, Nghiem TH, Schmid CH, Phelps DL, Pillers DA, Cole CH; AVIOx Study Group. Achieved versus intended pulse oximeter saturation in infants born less than 28 weeks' gestation: the AVIOx study. Pediatrics. 2006 Oct;118(4):1574-82. doi: 10.1542/peds.2005-0413.
PubMed 17015549
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maintaining Optimal Delivery Using Automatic Titration of Oxygen in Preterm Infants Receiving High Velocity Nasal Insufflation Therapy
- ClinicalTrials.gov ID
- NCT05030012
- Acronym / sponsor ID
- MODERATION Neo / RP-NIOA2019001Reg
- Conditions
- Infant, Premature, Neonatal Respiratory Distress, Oxygen Saturation, Bronchopulmonary Dysplasia
- Keywords
- High Velocity Nasal Insufflation (HVNI), Preterm Infants, Noninvasive Ventilatory Support, Automatic Oxygen Titration, Closed Loop Oxygen Control, High Flow Nasal Cannula
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No path to obtain FDA approval for the legacy Precision Flow OAM.
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Vapotherm, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Children's National Research Institute, Seattle Children's Hospital, University of Utah
- Study start
- 2 Sep 2021 (actual)
- Primary completion
- 19 Oct 2023 (actual)
- Study completion
- 19 Oct 2023 (actual)
- First posted
- 1 Sep 2021 (actual)
- Results
- Posted 26 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Oxygen treatment is common in management of preterm babies requiring intensive care. Delivery of too much or too little oxygen increase the risk of damage to eyes and lungs, and contributes to death and disability. Oxygen control in preterm infants requires frequent adjustments in the amount of oxygen delivered to the baby. This is generally performed manually by a clinician attending the baby, and generally directed to maintaining a specific range of blood oxygen saturation. The manual control often results in only half of the time in the specified range, with the baby experiencing high and low blood oxygen saturations.
The technology being studied is designed to assist the clinician in maintaining blood oxygen saturation within target range by measuring oxygen saturation and automatically adjusting the amount of oxygen delivered for babies receiving high velocity nasal insufflation (an advanced form of high flow oxygen therapy). The proposed study will evaluate the efficacy and safety of the automatic control of oxygen by the new technology, as compared to manual control, among babies receiving high velocity therapy in a neonatal intensive care unit.
Detailed description
Detailed Description: Supplemental oxygen is commonly administered to babies in neonatal intensive care units. The goal of oxygen therapy is to maintain normal oxygenation while minimizing hypoxemia and hypoxemia. Preterm infants are particularly vulnerable to oxygen toxicity and oxidative stress leading to retinopathy of prematurity (ROP), bronchopulmonary dysplasia (BPD), and periventricular leukomalacia (PVL). It's also well known that preterm infants experience hypoxic events exposing the baby to low oxygen levels. These hypoxic events vary as the infant matures, but exposure to prolonged and frequent episodes of hypoxemia is associated with increased morbidity and mortality. The delivery of oxygen is generally controlled by a clinician, and the control decisions are generally made using a non-invasive measure of blood oxygen saturation called pulse oximetry (SpO2) and is a standard of care in the neonatal intensive care unit. The most frequent item adjusted by clinicians to maintain SpO2 within specific target ranges is the fraction of the inspired oxygen (FiO2).
In a recent study by Reynolds, et al., caregiver manual control of oxygen delivered to NICU babies receiving high velocity therapy resulted in only 49% of the total 24-hour study period with the babies within the target SpO2 range (90-95%). by the caregiver based on the monitored oxygen saturation. Similar to the Reynolds findings, Hagadorn et al., conducted a study in 14 centers and showed that preterm infants under 28 weeks' gestation receiving oxygen spent on average only 48% of the time with SpO2 within the prescribed target range, about 36% of the time above and 16% of the time with SpO2 below the target range.
Preterm infants have frequent fluctuations in SpO2 due to their cardio-respiratory instability requiring frequent adjustments of FiO2 . Consequently, these particularly vulnerable infants spend significant time with SpO2 outside the optimal target range and are often exposed to extremes of hypoxemia and hyperoxaemia. The automatic oxygen control system continuously monitors the oxygen saturation and adjusts the oxygen delivery to maintain oxygen saturation within the target range. The efficacy of this mode of oxygen control was demonstrated by Reynolds, et al. in 2018 from two centers in the United Kingdom. Automated control of FiO2 can significantly improve compliance of oxygen saturation targeting and may significantly reduces exposure to hypoxemia as well as hyperoxaemia. The high velocity nasal insufflation therapy is a common mode of non-invasive respiratory support in preterm infants.
Unlike prior studies, this study will include a set of hypothesis-driven safety endpoints (proportion of time above or below target range), stratification by body mass at enrolment, and skin pigmentation phenotype. The objective of this randomized control trial is to evaluate the efficacy of the controller (Vapotherm Oxygen Assist Module [OAM]) in maintaining the SpO2 within target range for premature infants receiving high velocity therapy and presenting with a labile FiO2 requirement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study will be a prospective, multi-center, randomized, crossover trial evaluating automated oxygen titration versus manual titration in maintaining oxygen saturation levels in preterm infants requiring noninvasive ventilatory support via high velocity nasal insufflation (HVNI).
| Arm | Type | Receives |
|---|---|---|
| Automated Control (OAM) | Experimental | Device: Automated ControlIn this arm, FiO2 levels delivered via high-velocity nasal insufflation therapy (Vapotherm Precision Flow) will be adjusted by the Oxygen Assist Module (OAM) to keep the infants pulse oxygen saturation within a target range (90-95%). Clinical staff will have the ability to override FiO2 levels when required, and instructed to do so. |
| Manual Control (Manual) | Active comparator | Device: Manual ControlIn this arm, FiO2 levels delivered via high-velocity nasal insufflation therapy (Vapotherm Precision Flow) will be manually adjusted by clinical staff to keep infants' oxygen saturation between 90-95%. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Infants delivered at a gestational age of less than or equal to 35 6/7 weeks (Preterm) being treated with high velocity nasal insufflation therapy for the management of respiratory distress syndrome
- Patients that clinically require SpO2 maintenance within the target range of 90-95%
- A need for supplemental oxygen as demonstrated by a required FiO2 > 0.25 at enrollment
- Requiring a flow rate of greater than 2 L•min-1 such that the assumed inspired oxygen fraction matched delivered oxygen fraction (definition of HVNI).
- A minimum of 6 manual FiO2 adjustments in the 24hr period prior to trial enrollment.
Key exclusion criteria (8 listed)
- Current patient weight of <1000g or >3500g at time of study
- Major congenital abnormalities
- Hemodynamic instability, defined as being outside of a normotensive range based on an infant's individual characteristics by clinician
- Persistent unresolved apnea defined as: requiring 6 stimulations or more per 6 hours
- Seizures
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 |
|---|---|---|
| Automated ControlAlso: Oxygen Assist Module (OAM), Vapotherm OAM + Vapotherm Precision FlowThe purpose of this intervention is to evaluate that the efficacy and safety during the automated performance of the Vapotherm OAM are not inferior to standard care practice (manual control) in maintaining SpO2 levels of 90-95% in preterm infants requiring oxygen adjustments while being treated with high velocity nasal insufflation (HVNI) therapy. | Device | Automated Control (OAM) |
| Manual ControlAlso: Vapotherm Precision Flow, Treatment as Usual (TAU), Standard of Care (SOC)The purpose of this intervention is to establish an active comparator via standard care practice against which to evaluate the efficacy and safety of the automated arm of the study, for determination of non-inferiority of that automated control arm to manual control in maintaining SpO2 levels of 90-95% in preterm infants being treated with high velocity nasal insufflation (HVNI) therapy. | Device | Manual Control (Manual) |
Primary outcome
Primary Safety Objective - Percentage of Time Outside of SpO2 Target Range
Time frame: Through study completion, two consecutive 24-hour periods
Percentage of time spent outside target oxygen saturation range, measured by pulse oximetry (SpO2). A lower value indicates a better outcome.
Primary Performance Objective - Percentage of Time Within SpO2 Target Range
Time frame: Through study completion, two consecutive 24-hour periods
Percentage of time spent within target oxygen saturation range, measured by pulse oximetry (SpO2). A higher value indicates a better outcome.
2 secondary outcomes
Performance Endpoint, Percentage of Time IN Range (SpO2 in 90-95% With FiO2 Special at .21) Across the Two Weight Groups.
Time frame: Through study completion, two consecutive 24-hour periods
Secondary Performance Objective 2 - Percentage of Time Within SpO2 Target Range (Skin Pigmentation)
Time frame: Through study completion, two consecutive 24-hour periods
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 30464005Reynolds PR, Miller TL, Volakis LI, Holland N, Dungan GC, Roehr CC, Ives K. Randomised cross-over study of automated oxygen control for preterm infants receiving nasal high flow. Arch Dis Child Fetal Neonatal Ed. 2019 Jul;104(4):F366-F371. doi: 10.1136/archdischild-2018-315342. Epub 2018 Nov 21.
- Background: PubMed 17015549Hagadorn JI, Furey AM, Nghiem TH, Schmid CH, Phelps DL, Pillers DA, Cole CH; AVIOx Study Group. Achieved versus intended pulse oximeter saturation in infants born less than 28 weeks' gestation: the AVIOx study. Pediatrics. 2006 Oct;118(4):1574-82. doi: 10.1542/peds.2005-0413.
- 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.
Billie L Short, MD principal investigator
Children's National Research Institute
Khodayar Rais-Bahrami, MD principal investigator
Children's National Research Institute
Robert J DiGeronimo, MD principal investigator
Seattle Children's Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Infant, Premature and Neonatal Respiratory Distress, run by Vapotherm, Inc. at 3 sites in United States.
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 8 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: stopped early, as of the sponsor's last update on 26 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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?
Yes. Results are posted in the registry (first posted 26 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Primary Safety Objective - Percentage of Time Outside of SpO2 Target Range (time frame: Through study completion, two consecutive 24-hour periods). The study lists 2 primary outcomes in all. 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 NCT05030012, which also lists 2 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 26 Jun 2024.