StrokeNCT03761394
Pulsewatch: Smartwatch Monitoring for Atrial Fibrillation After Stroke
A study testing Testing Devices, Cardea Solo by Cardiac Insight and Kardia Mobile by AliveCor in people with Stroke and Atrial Fibrillation, run by University of Massachusetts, Worcester at 1 site in United States.
Trial summary
The goal of this research study is to develop a smartphone application capable of monitoring paroxysmal atrial fibrillation (pAF) in people who have survived a stroke or transient ischemic attack (TIA) or people who are at risk for a stroke and are age 50 and older. Read more about this study
- Who is it for?
- Ages 50 to 100 years
- Conditions the study is for
- Stroke, Atrial Fibrillation
- What is being tested?
- Testing Devices, Cardea Solo by Cardiac Insight and Kardia Mobile by AliveCor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Sep 2019to 20 Sep 2021
- 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 50 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of Transient Ischemic Attack (TIA) or stroke or at risk for stroke based on a CHA2DS2-VASc score equal to or greater to a score of 3, presenting at the UMass Memorial Medical Center (UMMMC) inpatient service or ambulatory clinic (neurology clinics and cardiovascular clinics included)
- Age: greater to or equal to 50 years of age
- Able to sign informed consent
- Willing to participant in a focus groups and/or Hack-a-thon for Aim 1 participants only
- Willing and capable of using Pulsewatch (smartwatch and smartphone app) daily for up to 44-days and returning to UMMMC for up to two study visits for Aims 2 and 3 participants only
Who cannot join
- Major contraindication to anti-coagulation treatment
- Plans to move our of the area over the 44-day follow up period
- Serious physical illness (e.g., unable to interact with a smart device, or communicate verbally or via written text) that would interfere with study participation
- Known allergies or hypersensitivities to medical grade hydrocolloid adhesives or hydrogel
- Patient with life threatening arrhythmia's who require in-patient monitoring for immediate analysis
- Patient with implantable pacemaker as paced beats interfere with ECG readings
Show all 14Show fewer
- Lacking capacity to sign informed consent
- Unable to read and write in English
- Plans to move from the area during the study period
- Unwilling to complete all study procedures
- Major contraindication to anti-coagulation treatment (i.e., major hemorrhagic stroke)
- Individuals who are not yet adults
- Pregnant women
- Prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site
UMass Chan Medical School
Worcester, Massachusetts, 01655
About this study
Official title: Smartwatch Monitoring for Atrial Fibrillation After Stroke
The goal of this research study is to develop a smartphone application capable of monitoring paroxysmal atrial fibrillation (pAF) in people who have survived a stroke or transient ischemic attack (TIA) or people who are at risk for a stroke and are age 50 and older. The study team plans to develop a highly effective and easy to use cardiovascular surveillance system to monitor patients for pAF on a nearly continuous basis. People involved in the development of this system include patients, their caregivers, health care providers, and computer programmers.
- Conditions
- Stroke, Atrial Fibrillation
- Being tested
- Testing Devices, Cardea Solo by Cardiac Insight, Kardia Mobile by AliveCor
- Keywords
- Cardiac Arrhythmias
- Medical subject headings
- Stroke, Atrial Fibrillation, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testing DevicesDevice
Pulsewatch system testing application on smartphone with smartwatch.
Cardea Solo by Cardiac InsightDevice
Gold-standard cardiac monitor for comparison of testing devices.
Kardia Mobile by AliveCorDevice
Mobile ECG device for comparison of testing devices during the extended use period.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Testing devices plus Cardea Solo device by Cardiac Insight for 14-day period. Receives: Device: Testing Devices; Device: Cardea Solo by Cardiac Insight |
| Control Group | Active comparator | Only Cardea Solo device by Cardiac Insight for 14-day period. Receives: Device: Cardea Solo by Cardiac Insight |
| Intervention Group for Extended Use | Experimental | 30-additional days of extended use of testing devices for adherence plus Kardia Mobile ECG device by AliveCor. Receives: Device: Testing Devices; Device: Kardia Mobile by AliveCor |
| Control Group for Extended Use | No intervention | No device usage for 30-days following completion of the original 14-day period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usability of Pulsewatch System (System Usability Scale & Rating Scale) at 14 Days Post the First Randomization
System usability scale, self-reported, of likes, dislikes, and problems encountered with the smartphone application and smartwatch. Each item regarding likes and dislikes will be scored 1-5 (1= strongly disagree; 5= strongly agree or Didn't use). Problem encountered will be scored with yes or no options with space provided for explanations. Also, using Mobile Application Rating Scale (MARS) App Classification questions will capture the participants' experience with the application. Each MARS item uses a 5-point scale (1=inadequate, 2=poor, 3=acceptable, 4=Good, 5=Excellent) and sub-scales will have an average mean to indicate the overall rating of the application.
Number of participants with SUS > 68 was reported in the Outcome Measure Data Table
Measured: Assessed 14 days post the first randomization
The Number of Participants With Atrial Fibrillation Detected by Smartwatch at the 14 Day Trial Period
This outcome was measured by the number of atrial fibrillation episodes identified by the smartwatch biosensors. This was conducted using two approaches. Firstly, the Pulsewatch app sent a message to participants to remain still and perform a 30-sec ECG self-check (wrist electrode, high accuracy) should they have an AF episode detected. The second approach involved the cancellation of cyclical frequencies, seen in accelerometer data, from the photoplethysmogram (PPG) signal. Thus, these two approaches were effectively used to recover some data segments contaminated by MNA or by poor signal quality and correctly identified the presence or absence of AF. Once MN artifacts were corrected, we looked at patterns to analyze pulse waveforms for AF detection, including discrimination of PVCs and PACs
Measured: Assessed throughout 14 day trial period
The Number of Participants With Detection of Atrial Fibrillation by a Patch Monitor (Confirmed by Cardiologist Overread) at 14 Days Post the First Randomization.
Episodes of atrial fibrillation was identified by the gold-standard monitor (Cardea Solo by Cardiac Insight). The Cardiac Insight patches have a module chip inside the sensor that stores the data being collected over the 14-days. After the participants returned the patches at the end of the 14-day monitoring period, a trained study staff removed the modules and placed them into the Cardiac insight smart cable to be uploaded to a UMass Medical School server. The ECG readings are then read by a board-certified cardiologist to confirm true atrial fibrillation detection.
Measured: Assessed at 14 days post the first randomization.
Secondary outcomes (7)
Change in Anxiety Symptoms at Baseline and at the Last Study Visit 30 Days Post the Second Randomization.
Anxiety will be assessed using the Generalized Anxiety Disorder-7 scale (GAD-7), a revised version of the anxiety module from the Patient Health Questionnaire, which consists of Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for generalized anxiety disorder over the past 2 weeks. The GAD-7 score ranges from 0-27 with scores of 5, 10 and 15 representing validated cut-points for mild, moderate and severe levels of anxiety symptoms, with a score ≥10 having high sensitivity (0.89) and specificity (0.82) for psychiatrist diagnosed anxiety disorder and correlates significantly with health-related QoL. This change in outcome was between baseline and the last study visit 30 days post the second randomization.
Measured: Assessed at baseline and at the last study visit 30 days post the second randomization (44 days)
Change in General Health MCS at Baseline and at the Last Study Visit 30 Days Post the Second Randomization (44 Days)
The Short Form (SF-12) health survey to assess health related quality of life, this validated instrument domains include general health questions and mental health related questions. Scores range from 0 to 100, where higher scores indicate higher level of health. This change in outcome was between baseline and the last study visit 30 days post the second randomization (44 days).
Measured: Assessed at baseline and at the last study visit 30 days post the second randomization (44 days)
Change in General Health PCS at Baseline and at the Last Study Visit 30 Days Post the Second Randomization (44 Days)
The Short Form (SF-12) health survey to assess health related quality of life, this validated instrument domains include general health questions and physical health-related questions. Scores range from 0 to 100, where higher scores indicate a higher level of health. This outcome was assessed at baseline and at the last study visit 30 days post the second randomization (44 days).
Measured: Assessed at baseline and at the last study visit 30 days post the second randomization (44 days)
Change in Disease Management Self-Efficacy (The General Disease Management Scale) at Baseline and 14 Days Post the First Randomization
Self-efficacy for disease management is associated with engagement in health behaviors and with improved medication adherence. The General Disease Management scale is a 5-item scale assessing confidence in disease self-management (scores 0-50, higher scores = greater confidence, lower scores = lower confidence). This change in outcome was between baseline and 14 days post the first randomization.
Measured: Assessed at baseline and 14 days post the first randomization
Change in Symptom Management Self-Efficacy at Baseline and 14 Days Post Randomization
Self-efficacy for disease management is associated with engagement in health behaviors and with improved medication adherence. The Symptom Management scale is a 5-item scale assessing confidence in managing chronic disease symptoms (items tailored to the sample), with scores ranging from 0 to 100. A higher symptom management score indicates a higher confidence in managing symptoms. Conversely, a lower score indicates a lower confidence in managing symptoms. This change in outcome was between baseline and 14 days post randomization.
Measured: Assessed at baseline and 14 days post randomization
Change in Patient Activation Score at Baseline and at the Last Study Visit 30 Days Post the Second Randomization (44 Days)
Patient activation refers to a patient's ability and willingness to manage their health. Activation will be measured using the 10-item Consumer Health Activation Index (CHAI). Scores range from 10 to 60. A higher score indicates that the patient has higher activation for self-management of their condition. Conversely, a lower score indicates lower activation for self-management of their condition. This change in outcome was between the baseline and the last study visit 30 days post the second randomization (44 days)
Measured: Assessed at baseline and at the last study visit 30 days post the second randomization (44 days)
Change in Medication Adherence at Baseline and 14 Days Post the First Randomization
Medication adherence will be measured using the 12-item Adherence to Refills and Medications Scale (ARMS), a well-validated measure of patient-reported adherence. The minimum to maximum ARMS score ranges from 1 to 4. Higher scores indicate poorer adherence, and lower scores indicate better medication adherence. This change in outcome was between baseline and 14 days post the first randomization.
Measured: Assessed at baseline and 14 days post the first randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2018
- Study start3 Sep 2019
- Primary completion20 Sep 2021
- Study completion20 Sep 2021
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 StrokeStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- University of Connecticut, Northeastern University, Brigham and Women's Hospital, National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Timothy P Fitzgibbons, MD, PhD, University of Massachusetts, Worcester
- Investigators
- Timothy Fitzgibbons, MD, PhD, Principal investigator, UMass Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03761394
- Sponsor's protocol ID
- H00016067
- Other IDs
- R01HL137734-01A1
- Status last verified
- Oct 2023
- First submitted
- 29 Nov 2018
- Last updated
- 18 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Ding EY, Tran KV, Lessard D, Wang Z, Han D, Mohagheghian F, Mensah Otabil E, Noorishirazi K, Mehawej J, Filippaios A, Naeem S, Gottbrecht MF, Fitzgibbons TP, Saczynski JS, Barton B, Chon K, McManus DD. Accuracy, Usability, and Adherence of Smartwatches for Atrial Fibrillation Detection in Older Adults After Stroke: Randomized Controlled Trial. JMIR Cardio. 2023 Nov 28;7:e45137. doi: 10.2196/45137.
PubMed 38015598Han D, Ding EY, Cho C, Jung H, Dickson EL, Mohagheghian F, Peitzsch AG, DiMezza D, Tran KV, McManus DD, Chon KH. A Smartwatch System for Continuous Monitoring of Atrial Fibrillation in Older Adults After Stroke or Transient Ischemic Attack: Application Design Study. JMIR Cardio. 2023 Feb 13;7:e41691. doi: 10.2196/41691.
PubMed 36780211
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smartwatch Monitoring for Atrial Fibrillation After Stroke
- ClinicalTrials.gov ID
- NCT03761394
- Acronym / sponsor ID
- H00016067
- Conditions
- Stroke, Atrial Fibrillation
- Keywords
- Cardiac Arrhythmias
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- University of Connecticut, Northeastern University, Brigham and Women's Hospital, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 3 Sep 2019 (actual)
- Primary completion
- 20 Sep 2021 (actual)
- Study completion
- 20 Sep 2021 (actual)
- First posted
- 3 Dec 2018 (actual)
- Results
- Posted 18 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this research study is to develop a smartphone application capable of monitoring paroxysmal atrial fibrillation (pAF) in people who have survived a stroke or transient ischemic attack (TIA) or people who are at risk for a stroke and are age 50 and older. The study team plans to develop a highly effective and easy to use cardiovascular surveillance system to monitor patients for pAF on a nearly continuous basis. People involved in the development of this system include patients, their caregivers, health care providers, and computer programmers.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Device: Testing Devices, Device: Cardea Solo by Cardiac InsightTesting devices plus Cardea Solo device by Cardiac Insight for 14-day period. |
| Control Group | Active comparator | Device: Cardea Solo by Cardiac InsightOnly Cardea Solo device by Cardiac Insight for 14-day period. |
| Intervention Group for Extended Use | Experimental | Device: Testing Devices, Device: Kardia Mobile by AliveCor30-additional days of extended use of testing devices for adherence plus Kardia Mobile ECG device by AliveCor. |
| Control Group for Extended Use | No intervention | –No device usage for 30-days following completion of the original 14-day period. |
Who may qualify
- Ages
- 50 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- History of Transient Ischemic Attack (TIA) or stroke or at risk for stroke based on a CHA2DS2-VASc score equal to or greater to a score of 3, presenting at the UMass Memorial Medical Center (UMMMC) inpatient service or ambulatory clinic (neurology clinics and cardiovascular clinics included)
- Age: greater to or equal to 50 years of age
- Able to sign informed consent
- Willing to participant in a focus groups and/or Hack-a-thon for Aim 1 participants only
- Willing and capable of using Pulsewatch (smartwatch and smartphone app) daily for up to 44-days and returning to UMMMC for up to two study visits for Aims 2 and 3 participants only
Key exclusion criteria (14 listed)
- Major contraindication to anti-coagulation treatment
- Plans to move our of the area over the 44-day follow up period
- Serious physical illness (e.g., unable to interact with a smart device, or communicate verbally or via written text) that would interfere with study participation
- Known allergies or hypersensitivities to medical grade hydrocolloid adhesives or hydrogel
- Patient with life threatening arrhythmia's who require in-patient monitoring for immediate analysis
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 |
|---|---|---|
| Testing DevicesPulsewatch system testing application on smartphone with smartwatch. | Device | Intervention Group, Intervention Group for Extended Use |
| Cardea Solo by Cardiac InsightGold-standard cardiac monitor for comparison of testing devices. | Device | Control Group, Intervention Group |
| Kardia Mobile by AliveCorMobile ECG device for comparison of testing devices during the extended use period. | Device | Intervention Group for Extended Use |
Primary outcome
Usability of Pulsewatch System (System Usability Scale & Rating Scale) at 14 Days Post the First Randomization
Time frame: Assessed 14 days post the first randomization
System usability scale, self-reported, of likes, dislikes, and problems encountered with the smartphone application and smartwatch. Each item regarding likes and dislikes will be scored 1-5 (1= strongly disagree; 5= strongly agree or Didn't use). Problem encountered will be scored with yes or no options with space provided for explanations. Also, using Mobile Application Rating Scale (MARS) App Classification questions will capture the participants' experience with the application. Each MARS item uses a 5-point scale (1=inadequate, 2=poor, 3=acceptable, 4=Good, 5=Excellent) and sub-scales will have an average mean to indicate the overall rating of the application. Number of participants with SUS > 68 was reported in the Outcome Measure Data Table
The Number of Participants With Atrial Fibrillation Detected by Smartwatch at the 14 Day Trial Period
Time frame: Assessed throughout 14 day trial period
This outcome was measured by the number of atrial fibrillation episodes identified by the smartwatch biosensors. This was conducted using two approaches. Firstly, the Pulsewatch app sent a message to participants to remain still and perform a 30-sec ECG self-check (wrist electrode, high accuracy) should they have an AF episode detected. The second approach involved the cancellation of cyclical frequencies, seen in accelerometer data, from the photoplethysmogram (PPG) signal. Thus, these two approaches were effectively used to recover some data segments contaminated by MNA or by poor signal quality and correctly identified the presence or absence of AF. Once MN artifacts were corrected, we looked at patterns to analyze pulse waveforms for AF detection, including discrimination of PVCs and PACs
The Number of Participants With Detection of Atrial Fibrillation by a Patch Monitor (Confirmed by Cardiologist Overread) at 14 Days Post the First Randomization.
Time frame: Assessed at 14 days post the first randomization.
Episodes of atrial fibrillation was identified by the gold-standard monitor (Cardea Solo by Cardiac Insight). The Cardiac Insight patches have a module chip inside the sensor that stores the data being collected over the 14-days. After the participants returned the patches at the end of the 14-day monitoring period, a trained study staff removed the modules and placed them into the Cardiac insight smart cable to be uploaded to a UMass Medical School server. The ECG readings are then read by a board-certified cardiologist to confirm true atrial fibrillation detection.
7 secondary outcomes
Change in Anxiety Symptoms at Baseline and at the Last Study Visit 30 Days Post the Second Randomization.
Time frame: Assessed at baseline and at the last study visit 30 days post the second randomization (44 days)
Change in General Health MCS at Baseline and at the Last Study Visit 30 Days Post the Second Randomization (44 Days)
Time frame: Assessed at baseline and at the last study visit 30 days post the second randomization (44 days)
Change in General Health PCS at Baseline and at the Last Study Visit 30 Days Post the Second Randomization (44 Days)
Time frame: Assessed at baseline and at the last study visit 30 days post the second randomization (44 days)
Change in Disease Management Self-Efficacy (The General Disease Management Scale) at Baseline and 14 Days Post the First Randomization
Time frame: Assessed at baseline and 14 days post the first randomization
Change in Symptom Management Self-Efficacy at Baseline and 14 Days Post Randomization
Time frame: Assessed at baseline and 14 days post randomization
Change in Patient Activation Score at Baseline and at the Last Study Visit 30 Days Post the Second Randomization (44 Days)
Time frame: Assessed at baseline and at the last study visit 30 days post the second randomization (44 days)
Change in Medication Adherence at Baseline and 14 Days Post the First Randomization
Time frame: Assessed at baseline and 14 days post the first randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38015598Ding EY, Tran KV, Lessard D, Wang Z, Han D, Mohagheghian F, Mensah Otabil E, Noorishirazi K, Mehawej J, Filippaios A, Naeem S, Gottbrecht MF, Fitzgibbons TP, Saczynski JS, Barton B, Chon K, McManus DD. Accuracy, Usability, and Adherence of Smartwatches for Atrial Fibrillation Detection in Older Adults After Stroke: Randomized Controlled Trial. JMIR Cardio. 2023 Nov 28;7:e45137. doi: 10.2196/45137.
- Derived from this study: PubMed 36780211Han D, Ding EY, Cho C, Jung H, Dickson EL, Mohagheghian F, Peitzsch AG, DiMezza D, Tran KV, McManus DD, Chon KH. A Smartwatch System for Continuous Monitoring of Atrial Fibrillation in Older Adults After Stroke or Transient Ischemic Attack: Application Design Study. JMIR Cardio. 2023 Feb 13;7:e41691. doi: 10.2196/41691.
- 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.
Timothy Fitzgibbons, MD, PhD principal investigator
UMass Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Testing Devices, Cardea Solo by Cardiac Insight and Kardia Mobile by AliveCor in people with Stroke and Atrial Fibrillation, run by University of Massachusetts, Worcester at 1 site 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 5 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 18 Nov 2023. 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 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 18 Nov 2023). 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?
Usability of Pulsewatch System (System Usability Scale & Rating Scale) at 14 Days Post the First Randomization (time frame: Assessed 14 days post the first randomization). The study lists 3 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 NCT03761394, 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 18 Nov 2023.