Gestational HypertensionNCT06647511
Digital Solutions to Reduce Maternal Morbidity and Mortality in Pregnant Refugee Women
An observational study of Gestational Hypertension, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
The goal of this observational study is to use digital health tracking to improve how high blood pressure and other health issues are detected in pregnant refugee women. The main questions this study aims to answer are are: Can a digital monitoring system that checks for high blood pressure in these women be tested… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Hypertension
- What is being tested?
- Nokia-Withings BPM Connect Blood Pressure Monitor and Smartwatch Devices
- Type of treatment
- Medical device
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Sep 2024to Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population is a pregnant refugee, or asylee as designated by the U.S. Government.
Who may be able to join
- Pregnant
- Refugee, asylum seeking, or asylee as designated by the U.S. Government
- Greater than or equal to 18 years of age
- Has a personal smartphone
Who cannot join
- Unable to provide informed consent
- Determined by the PI to be in an extremely vulnerable position and therefore not suited for research participation
- Planned move from the New York City (NYC) area within the next 24 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Weill Cornell Medicine
New York, New York, 10065
Gunisha Kaur, MA, MD, 212-746-2461, gus2004@med.cornell.edu
Michele Steinkamp, RN, 212-746-2953, mls9004@med.cornell.edu
About this study
The goal of this observational study is to use digital health tracking to improve how high blood pressure and other health issues are detected in pregnant refugee women. The main questions this study aims to answer are are:
- Can a digital monitoring system that checks for high blood pressure in these women be tested and refined, using clinical training and validation?
- Can this digital monitoring system accurately track any related pregnancy health issues and be used to refer participants to care providers?
- Can this system be used to accurately identify risks associated with the contraction of pregnancy-related conditions, such as preeclampsia and high blood pressure?
Read more
Participants will:
- Complete baseline and follow-up in-person appointments;
- Complete surveys at these appointment that track their health, stress levels, and comorbidities/risks associated with pregnancy;
- Be given a smartwatch fitness tracker and electronic blood pressure cuffs for at-home measurements.
Read the detailed description
The objective of this application, funded by the National Academy of Medicine Catalyst Award, is to maximize the performance of a digital cardiovascular monitoring system to detect gestational hypertension in pregnant refugee women. The central hypothesis is that the application of these digital health technologies will be able to diagnose gestational hypertension in refugee mothers with 85% sensitivity as compared to the gold standard (clinical diagnosis). The rationale for this investigation is to improve the diagnosis of hypertension in refugee mothers, leading to targeted treatment.
This study's primary objective is to maximize the performance of digital health monitoring systems to detect gestational hypertension through system training and validation. The investigators aim to do this by utilizing technologies such as smartwatches and electronic blood pressure monitors to track health data throughout enrollment. Tracking this health data will also allow study investigators to track several other comorbid conditions in refugee mothers. This collection will take place over 24 months to train and validate this digital system. The performance of the prediction models will be assessed using two measures: Receiver Operating Characteristic (ROC) curve analysis, which evaluates the model's discrimination ability between disease states; and the Integrated Brier Score (cumulative mean squared error over time) will provide data on the model's predictive accuracy and reliability.
The secondary objectives of this study are to document comorbid illness and stress, assess the program's ability to make successful referrals, and connect the study population with healthcare providers for primary care visits. This will be completed by digital health tracking and the retention of contact with the participants throughout the duration of their enrollment.
- Conditions
- Gestational Hypertension
- Being tested
- Nokia-Withings BPM Connect Blood Pressure Monitor, Smartwatch Devices
- Keywords
- refugee, pregnant, digital
- Medical subject headings
- Hypertension, Pregnancy-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nokia-Withings BPM Connect Blood Pressure MonitorDevice
At-home blood pressure (BP) measurements will be weekly via a blood pressure cuff (e.g., Nokia-Withings BPM (Beats per Minute) Connect), with measurements being manually entered into the study specific smartphone app.
Smartwatch DevicesDevice
Passive continuous collection of digital data (e.g., daily heart rate trends, activity levels, sleep measurements) for exploratory outcomes will occur via Apple Watches and Fitbit Versa 3s, which are synced to a smartphone application.
| Study group | Role | What they receive |
|---|---|---|
| Pregnant Refugees | Participants will complete validated questionnaires, regular blood pressure measurements, pain and trauma assessments, and clinical monitoring during this study. Receives: Device: Nokia-Withings BPM Connect Blood Pressure Monitor; Device: Smartwatch Devices |
What is being measured
The primary outcome is the main question the study is designed to answer.
Digital Sensitivity for detecting gestational hypertension (HTN)
The diagnostic accuracy of the digital blood pressure cuffs will be compared to the measurements taken during in-person visits.
Measured: 13 months [maximum duration of enrollment]
Secondary outcomes (20)
Number of Participants that Complete All Surveys Between Appointments
The completion of weekly surveys will be assessed for each participant and the number of participants that complete all surveys sent to them will be compared to the overall number of participants enrolled.
Measured: 13 months [maximum duration of enrollment]
Number of Participants That Complete All Surveys at the Baseline Appointment
The number of participants that complete every single survey at the baseline appointment out of the total number of participants will be recorded.
Measured: 13 months [maximum duration of enrollment]
Number of Participants Referred to Physicians/Care that do not have a designated provider
Participants without designated care providers during their pregnancy will be noted and the number of participants that are successfully referred to physicians/other providers will be recorded.
Measured: 13 months [maximum duration of enrollment]
Number of Participants With No Comorbid Pain as Assessed by BPI-SF
Chronic pain will be evaluated using the validated Brief Pain Inventory - Short Form (BPI-SF). The mean BPI-SF score quantifies pain severity (worst, least, average, and now) and pain interference into the following: none (score 0), mild (1-4), moderate (4-6), or severe (7-10).The number of participants who score 0 on the BPI-SF will be measured.
Measured: 13 months [maximum duration of enrollment]
Number of Participants With Mild Comorbid Pain as Assessed by BPI-SF
Chronic pain will be evaluated using the validated Brief Pain Inventory - Short Form (BPI-SF). The mean BPI-SF score quantifies pain severity (worst, least, average, and now) and pain interference into the following: none (score 0), mild (1-4), moderate (4-6), or severe (7-10).The number of participants who score from 1-4 on the BPI-SF will be measured.
Measured: 13 months [maximum duration of enrollment]
Number of Participants With Moderate Comorbid Pain as Assessed by BPI-SF
Chronic pain will be evaluated using the validated Brief Pain Inventory - Short Form (BPI-SF). The mean BPI-SF score quantifies pain severity (worst, least, average, and now) and pain interference into the following: none (score 0), mild (1-4), moderate (4-6), or severe (7-10).The number of participants who score from 4-6 on the BPI-SF will be measured.
Measured: 13 months [maximum duration of enrollment]
Number of Participants With Severe Comorbid Pain as Assessed by BPI-SF
Chronic pain will be evaluated using the validated Brief Pain Inventory - Short Form (BPI-SF). The mean BPI-SF score quantifies pain severity (worst, least, average, and now) and pain interference into the following: none (score 0), mild (1-4), moderate (4-6), or severe (7-10).The number of participants who score from 7-10 on the BPI-SF will be measured.
Measured: 13 months [maximum duration of enrollment]
Number of Participants with Low Comorbid Stress as Assessed by the PSS
Stress levels will be evaluated using the validated Perceived Stress Scale (PSS). The PSS ranges from 0 to 40, with 0-13 considered low stress, 14-26 considered moderate stress, and 27-40 considered high stress. The number of participants who score from 0-13 will be measured.
Measured: 13 months [maximum duration of enrollment]
Number of Participants with Moderate Comorbid Stress as Assessed by the PSS
Stress levels will be evaluated using the validated Perceived Stress Scale (PSS). The PSS ranges from 0 to 40, with 0-13 considered low stress, 14-26 considered moderate stress, and 27-40 considered high stress. The number of participants who score from 14-26 will be measured.
Measured: 13 months [maximum duration of enrollment]
Number of Participants with High Comorbid Stress as Assessed by the PSS
Stress levels will be evaluated using the validated Perceived Stress Scale (PSS). The PSS ranges from 0 to 40, with 0-13 considered low stress, 14-26 considered moderate stress, and 27-40 considered high stress. The number of participants who score from 27-40 will be measured.
Measured: 13 months [maximum duration of enrollment]
Number of Participants with Comorbid Stress as Assessed by the SOIS
Stress levels will be evaluated using the validated Stress of Immigration Survey (SOIS). The SOIS is considered positive if any item on the survey is "yes," with the mean of all items giving an overall severity score from 1-5.
Measured: 13 months [maximum duration of enrollment]
Number of Participants Who Score Positive for PTSD Symptoms on the HTQ
Mental health status will be evaluated using the validated Harvard Trauma Questionnaire (HTQ). The HTQ is positive for PTSD symptoms if the average score from Part IV is ≥2.5. The number of participants who have a positive score on the HTQ will be recorded.
Measured: 13 months [maximum duration of enrollment]
Number of Participants Who Score Positive for Anxiety on the HSCL
Mental health status will be evaluated using the Hopkins Symptoms Checklist (HSCL). the HSCL is positive for anxiety if the average of items 1-10 or total averaged score is more than or equal to 1.75. The number of participants who have a positive score on the HSCL for anxiety will be recorded.
Measured: 13 months [maximum duration of enrollment]
Number of Participants Who Score Positive for Depression on the HSCL
Mental health status will be evaluated using the Hopkins Symptoms Checklist (HSCL). the HSCL is positive for depression if the average of items 11-25 or total averaged score is more than or equal to 1.75. The number of participants who have a positive score on the HSCL for depression will be recorded.
Measured: 13 months [maximum duration of enrollment]
Number of Participants with Cardiovascular Risk Factors and Disease as Assessed by the WHO Rose Angina Questionnaire.
Participants will be assessed for cardiovascular risk factors and disease using the World Health Organization (Rose) Angina Questionnaire (WHOAQ). The WHOAQ is deemed positive if any symptoms are recorded on the survey.
Measured: 13 months [maximum duration of enrollment]
Number of Participants with Low Cardiovascular Risk Factors and Disease as Assessed by the AHA Atherosclerotic Cardiovascular Disease Pooled Cohort Equation
Cardiovascular risk factors and disease will be assessed using the American Heart Association (AHA) atherosclerotic cardiovascular disease (ASCVD) Pooled Cohort Equation (PCE) risk estimator. AHA ASCVD PCE Scores identify the risk of first occurrence of myocardial infarction or stroke. A score of less than 5% is low; 5%-7.5% is borderline; 7.5%-20% is intermediate; ≥20% is high. The number of participants that score less than 5% will be measured.
Measured: 13 months [maximum duration of enrollment]
Number of Participants with Borderline Cardiovascular Risk Factors and Disease as Assessed by the AHA Atherosclerotic Cardiovascular Disease Pooled Cohort Equation
Cardiovascular risk factors and disease will be assessed using the American Heart Association (AHA) atherosclerotic cardiovascular disease (ASCVD) Pooled Cohort Equation (PCE) risk estimator. AHA ASCVD PCE Scores identify the risk of first occurrence of myocardial infarction or stroke. A score of less than 5% is low; 5%-7.5% is borderline; 7.5%-20% is intermediate; ≥20% is high. The number of participants who score from 5%-7.5% will be measured.
Measured: 13 months [maximum duration of enrollment]
Number of Participants with Intermediate Cardiovascular Risk Factors and Disease as Assessed by the AHA Atherosclerotic Cardiovascular Disease Pooled Cohort Equation
Cardiovascular risk factors and disease will be assessed using the American Heart Association (AHA) atherosclerotic cardiovascular disease (ASCVD) Pooled Cohort Equation (PCE) risk estimator. AHA ASCVD PCE Scores identify the risk of first occurrence of myocardial infarction or stroke. A score of less than 5% is low; 5%-7.5% is borderline; 7.5%-20% is intermediate; ≥20% is high. The number of participants who score from 7.5%-20% will be measured.
Measured: 13 months [maximum duration of enrollment]
Number of Participants with High Cardiovascular Risk Factors and Disease as Assessed by the AHA Atherosclerotic Cardiovascular Disease Pooled Cohort Equation
Cardiovascular risk factors and disease will be assessed using the American Heart Association (AHA) atherosclerotic cardiovascular disease (ASCVD) Pooled Cohort Equation (PCE) risk estimator. AHA ASCVD PCE Scores identify the risk of first occurrence of myocardial infarction or stroke. A score of less than 5% is low; 5%-7.5% is borderline; 7.5%-20% is intermediate; ≥20% is high. The number of participants who score above 20% will be measured.
Measured: 13 months [maximum duration of enrollment]
Number of Participants with Cardiovascular Risk Factors and Disease as Assessed by the QVSFS
Participants will be assessed for cardiovascular risk factors and disease by using the Questionnaire for Verifying Stroke-Free Status (QVSFS). The QVSFS is positive if any questions are answered in the affirmative.
Measured: 13 months [maximum duration of enrollment]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2024
- Study start12 Sep 2024
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational HypertensionStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- National Academy of Medicine, Cornell University, Apple Inc.
- Responsible party
- Sponsor
- Investigators
- Gunisha Kaur, MA, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06647511
- Sponsor's protocol ID
- 24-01026913
- Status last verified
- Apr 2026
- First submitted
- 15 Oct 2024
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Digital Solutions to Reduce Maternal Morbidity and Mortality in Pregnant Refugee Women
- ClinicalTrials.gov ID
- NCT06647511
- Acronym / sponsor ID
- 24-01026913
- Conditions
- Gestational Hypertension
- Keywords
- refugee, pregnant, digital
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- National Academy of Medicine, Cornell University, Apple Inc.
- Study start
- 12 Sep 2024 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 17 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to use digital health tracking to improve how high blood pressure and other health issues are detected in pregnant refugee women. The main questions this study aims to answer are are:
- Can a digital monitoring system that checks for high blood pressure in these women be tested and refined, using clinical training and validation?
- Can this digital monitoring system accurately track any related pregnancy health issues and be used to refer participants to care providers?
- Can this system be used to accurately identify risks associated with the contraction of pregnancy-related conditions, such as preeclampsia and high blood pressure?
Participants will:
- Complete baseline and follow-up in-person appointments;
- Complete surveys at these appointment that track their health, stress levels, and comorbidities/risks associated with pregnancy;
- Be given a smartwatch fitness tracker and electronic blood pressure cuffs for at-home measurements.
Detailed description
The objective of this application, funded by the National Academy of Medicine Catalyst Award, is to maximize the performance of a digital cardiovascular monitoring system to detect gestational hypertension in pregnant refugee women. The central hypothesis is that the application of these digital health technologies will be able to diagnose gestational hypertension in refugee mothers with 85% sensitivity as compared to the gold standard (clinical diagnosis). The rationale for this investigation is to improve the diagnosis of hypertension in refugee mothers, leading to targeted treatment.
This study's primary objective is to maximize the performance of digital health monitoring systems to detect gestational hypertension through system training and validation. The investigators aim to do this by utilizing technologies such as smartwatches and electronic blood pressure monitors to track health data throughout enrollment. Tracking this health data will also allow study investigators to track several other comorbid conditions in refugee mothers. This collection will take place over 24 months to train and validate this digital system. The performance of the prediction models will be assessed using two measures: Receiver Operating Characteristic (ROC) curve analysis, which evaluates the model's discrimination ability between disease states; and the Integrated Brier Score (cumulative mean squared error over time) will provide data on the model's predictive accuracy and reliability.
The secondary objectives of this study are to document comorbid illness and stress, assess the program's ability to make successful referrals, and connect the study population with healthcare providers for primary care visits. This will be completed by digital health tracking and the retention of contact with the participants throughout the duration of their enrollment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pregnant Refugees | – | Device: Nokia-Withings BPM Connect Blood Pressure Monitor, Device: Smartwatch DevicesParticipants will complete validated questionnaires, regular blood pressure measurements, pain and trauma assessments, and clinical monitoring during this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is a pregnant refugee, or asylee as designated by the U.S. Government.
Key inclusion criteria (4 listed)
- Pregnant
- Refugee, asylum seeking, or asylee as designated by the U.S. Government
- Greater than or equal to 18 years of age
- Has a personal smartphone
Key exclusion criteria (3 listed)
- Unable to provide informed consent
- Determined by the PI to be in an extremely vulnerable position and therefore not suited for research participation
- Planned move from the New York City (NYC) area within the next 24 months
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 |
|---|---|---|
| Nokia-Withings BPM Connect Blood Pressure MonitorAt-home blood pressure (BP) measurements will be weekly via a blood pressure cuff (e.g., Nokia-Withings BPM (Beats per Minute) Connect), with measurements being manually entered into the study specific smartphone app. | Device | Pregnant Refugees |
| Smartwatch DevicesPassive continuous collection of digital data (e.g., daily heart rate trends, activity levels, sleep measurements) for exploratory outcomes will occur via Apple Watches and Fitbit Versa 3s, which are synced to a smartphone application. | Device | Pregnant Refugees |
Primary outcome
Digital Sensitivity for detecting gestational hypertension (HTN)
Time frame: 13 months [maximum duration of enrollment]
The diagnostic accuracy of the digital blood pressure cuffs will be compared to the measurements taken during in-person visits.
20 secondary outcomes
Number of Participants that Complete All Surveys Between Appointments
Time frame: 13 months [maximum duration of enrollment]
Number of Participants That Complete All Surveys at the Baseline Appointment
Time frame: 13 months [maximum duration of enrollment]
Number of Participants Referred to Physicians/Care that do not have a designated provider
Time frame: 13 months [maximum duration of enrollment]
Number of Participants With No Comorbid Pain as Assessed by BPI-SF
Time frame: 13 months [maximum duration of enrollment]
Number of Participants With Mild Comorbid Pain as Assessed by BPI-SF
Time frame: 13 months [maximum duration of enrollment]
Number of Participants With Moderate Comorbid Pain as Assessed by BPI-SF
Time frame: 13 months [maximum duration of enrollment]
Number of Participants With Severe Comorbid Pain as Assessed by BPI-SF
Time frame: 13 months [maximum duration of enrollment]
Number of Participants with Low Comorbid Stress as Assessed by the PSS
Time frame: 13 months [maximum duration of enrollment]
Number of Participants with Moderate Comorbid Stress as Assessed by the PSS
Time frame: 13 months [maximum duration of enrollment]
Number of Participants with High Comorbid Stress as Assessed by the PSS
Time frame: 13 months [maximum duration of enrollment]
Number of Participants with Comorbid Stress as Assessed by the SOIS
Time frame: 13 months [maximum duration of enrollment]
Number of Participants Who Score Positive for PTSD Symptoms on the HTQ
Time frame: 13 months [maximum duration of enrollment]
Number of Participants Who Score Positive for Anxiety on the HSCL
Time frame: 13 months [maximum duration of enrollment]
Number of Participants Who Score Positive for Depression on the HSCL
Time frame: 13 months [maximum duration of enrollment]
Number of Participants with Cardiovascular Risk Factors and Disease as Assessed by the WHO Rose Angina Questionnaire.
Time frame: 13 months [maximum duration of enrollment]
Number of Participants with Low Cardiovascular Risk Factors and Disease as Assessed by the AHA Atherosclerotic Cardiovascular Disease Pooled Cohort Equation
Time frame: 13 months [maximum duration of enrollment]
Number of Participants with Borderline Cardiovascular Risk Factors and Disease as Assessed by the AHA Atherosclerotic Cardiovascular Disease Pooled Cohort Equation
Time frame: 13 months [maximum duration of enrollment]
Number of Participants with Intermediate Cardiovascular Risk Factors and Disease as Assessed by the AHA Atherosclerotic Cardiovascular Disease Pooled Cohort Equation
Time frame: 13 months [maximum duration of enrollment]
Number of Participants with High Cardiovascular Risk Factors and Disease as Assessed by the AHA Atherosclerotic Cardiovascular Disease Pooled Cohort Equation
Time frame: 13 months [maximum duration of enrollment]
Number of Participants with Cardiovascular Risk Factors and Disease as Assessed by the QVSFS
Time frame: 13 months [maximum duration of enrollment]
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- 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.
Gunisha Kaur, MA, MD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gestational Hypertension, run by Weill Medical College of Cornell University 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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 22 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gunisha Kaur, MA, MD ((212) 746-2461, gus2004@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Digital Sensitivity for detecting gestational hypertension (HTN) (time frame: 13 months [maximum duration of enrollment]). 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 22 Apr 2026.