Osteo Arthritis KneeNCT06701461
Measurement of Osteoarthritic Patient Pain Through Electrodermal Activity Signals
A study testing Electrodermal Activity signal in people with Osteo Arthritis Knee, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
Trial summary
This pilot study aims to investigate the viability of using a smartwatch-based electrodermal activity (EDA) sensor to capture enough EDA signal to quantitatively assess pain in osteoarthritis subjects and test the feasibility of its methods and procedures for later use in subsequent larger-scale studies. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteo Arthritis Knee
- What is being tested?
- Electrodermal Activity signal
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2026to Oct 2026
- Phase
- Interventional
- 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 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Kellgren-Lawrence Grade >= 3
Who cannot join
- Inflammatory arthropathy (e.g., rheumatoid arthritis), BMI >=35
- Control subjects:
- Complaints of lower extremity joint pain
- Known diagnosis of knee osteoarthpathy
- Prior history of knee surgery, knee injections, or injury to knee joints (e.g., meniscus tears, ligamentous injuries), BMI >=35
- Both groups, exclusion:
Show all 19Show fewer
- Subjects with chronic heart problems, including, but not limited to, chronic hypertension, heart palpitations, a weak or irregular heartbeat, or a previous heart attack,
- Subjects taking the following drugs within 12 hours of the experiment or during the experiment: caffeine, alcohol, psychoactive drugs, nicotine or marijuana, other recreational drugs, and medicine of any kind that is not normally taken daily. Such medications include;
- NSAIDs
- Acetaminophen
- Steroidal anti-inflammatory agents
- Bronchodilators
- Appetite suppressants
- Lipase inhibitors
- Women who are currently pregnant
- Subjects with Raynaud's syndrome
- Subjects with any of the following conditions: active skin lesions where EDA sensors are, vertigo or dizziness, and anyone with postural orthostatic tachycardia syndrome (POTS), peripheral neuropathy, seizure disorders, methicillin-resistant staphylococcus aureus (MRSA), impaired circulation, medical implants, open skin lesions, chronic eczema on hands where EDA and electrical stimulator's electrodes are attached, diabetes, and epilepsy.
- Participants who have a skin sensitivity to metals, have a pacemaker or defibrillator, or have recent head trauma within the past two weeks (even without loss of consciousness)
- Participants who cannot feel physical pain or have a history of self-harm
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
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756
Jon M Coordinator, MD, MS, 603-653-3306, jon.mikael.anderson@hitchcock.org
Peter L Schilling, MD, MS
About this study
This pilot study aims to investigate the viability of using a smartwatch-based electrodermal activity (EDA) sensor to capture enough EDA signal to quantitatively assess pain in osteoarthritis subjects and test the feasibility of its methods and procedures for later use in subsequent larger-scale studies.
Read the detailed description
Chronic pain, a disease in its own right, afflicts one in three adults in the US and poses an enormous economic burden ($560-$635 billion annually), more than heart disease, cancer, and diabetes. To treat pain, doctors often prescribe opioids to suffering patients. Paradoxically, prescription opioid abuse has become a national epidemic, costing $500 billion annually in medical, economic, social, and criminal ramifications. However, the development of effective treatment for chronic pain is hampered by the lack of a reliable biomarker that can quantify the level of pain and detect any attenuation after treatment. This is reflected in the failed statistical significance in many clinical trials of drugs for managing chronic pain (e.g., ONO-2952 and Ibodutant) or a large enrollment number being required to reveal significant but small effects (e.g., 1,798 enrollments for the trial on Renzapride).
Dysfunction of the autonomic nervous system (ANS) has been linked with many chronic pain conditions. The ANS is the primary pathway in brain-gut communication and manifests the body's emotional and psychological states. This makes it particularly relevant to pain, which has a strong emotional component. The ANS includes the sympathetic (SNS) and parasympathetic nervous systems (PNS), and chronic pain conditions reportedly correlate with an unchecked predominance of SNS activity and desensitized PNS. Thus, the PNS and SNS are promising targets for developing sensitive and robust biomarkers for chronic pain.
The investigators will leverage the EmbracePlus smartwatch for the non-invasive quantification of both SNS and PNS activities with time- and frequency-domain analysis of EDA. In this proposed pilot study, the investigators aim to establish whether this biomarker for quantifying pain levels shows promise for osteoarthritis patients when detected through a smartwatch. This is intended to be preliminary work to support a grant application for a more extensive study. In this work, the investigators will collect EDA measurements across up to 15 subjects (2/3 with symptomatic osteoarthritis (Kellgren-Lawrence grade \>= 3) and 1/3 control). Each participant's baseline response will first be measured using a thermal grill (a research device commonly used to induce a painful stimulus without injury). Participants will also report their results using a VAS. Then, Participants will be put through three OARSI standardized functional tests: the 30-second chair test, the 40m fast-paced walk, and the stair climb test. During these tests, subjects will receive a handheld clicker to mark moments of their sharpest pain. The results of each test will then be analyzed through a set of time- and frequency-domain analyses of the recorded bio-signals to extract key parameters and measure how well EDA signal detection captured both sharp and dull pain in subjects.
If effective, this method can be particularly useful. Existing commercial wearable sensors can collect patient data for a week at a time. This would allow for the collection of in-vivo and continuous patient pain data, which could greatly enhance the understanding of patient pain both pre- and post-treatment.
- Conditions
- Osteo Arthritis Knee
- Being tested
- Electrodermal Activity signal
- Keywords
- Pain, Electrodermal Activity Signals, Osteoarthritis, Knee
- Medical subject headings
- Pain, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrodermal Activity signalDevice
Determining if the electrodermal activity signals, as measured by the Embrace Plus smartwatch) can be used to measure osteoarthritic patient pain levels.
| Study group | Role | What they receive |
|---|---|---|
| Electrodermal Activity Measurement Subjects | Experimental | Participants will have their baseline electrodermal activity (EDA) response to pain measured as well as their EDA response measured while participating in a set of standardized functional tests. Receives: Device: Electrodermal Activity signal |
What is being measured
The primary outcome is the main question the study is designed to answer.
:Difference in pain measurements as reported by the participant via a visual analogue scale versus smartwatch reported electrodermal activity sensors
As a pilot study, the goal is not hypothesis testing but rather examining the feasibility of this approach to measuring patient pain in osteoarthritic patients. Thus, the statistical analysis will be primarily descriptive. The baseline experiment is being done to see whether the smartwatch measurements are at all comparable to prior similar experiments using the thermal grill (Posada-Quintero 2016; Posada-Quintero 2021). For this reason, though not typical for a pilot study, participant responses to the baseline test will use similar analysis to prior electrodermal activity (EDA) based thermal grill studies to see if the smartwatch poses a viable EDA signal collection source. This primarily consists of repeated measures analysis of variance (ANOVA) comparing patient-reported visual analog scale (VAS) scores to EDA output.
Measured: 40 minutes of test time, occurring all in one day.
Patient-reported pain during standardized Osteoarthritis Research Society International (OARSI) 30-second chair test
Patients will be asked to participate in the standardized OARSI 30-second chair test. During the OARSI functional tests, the timestamps of patient reports of pain will be recorded by the experimenter.
Measured: 5 minutes
Electrodermal activity (EDA) signals during standardized Osteoarthritis Research Society International (OARSI) 30-second chair test
A smartwatch will capture the patient's EDA signals during the 30-second chair test
Measured: 0 minutes. Concurrent with measurement of patient-reported pain.
Patient-reported pain during standardized Osteoarthritis Research Society International (OARSI) 40m fast-paced walk test
Patients will be asked to participate in the standardized OARSI 40m fast-paced walk test. During the OARSI functional tests, the timestamps of patient reports of pain will be recorded by the experimenter.
Measured: 10 minutes
Electrodermal activity (EDA) signals during standardized Osteoarthritis Research Society International (OARSI) 40m fast-paced walk test
A smartwatch will capture the patient's EDA signals during the 40m fast-paced walk test
Measured: 0 minutes. Concurrent with measurement of patient-reported pain.
Patient-reported pain during standardized Osteoarthritis Research Society International (OARSI) stair climb test
Patients will be asked to participate in the standardized OARSI stair climb test. During the OARSI functional tests, the timestamps of patient reports of pain will be recorded by the experimenter.
Measured: 10 minutes
Electrodermal activity (EDA) signals during standardized Osteoarthritis Research Society International (OARSI) stair climb test
A smartwatch will capture the patient's EDA signals during the stair climb test
Measured: 0 minutes. Concurrent with measurement of patient-reported pain.
Accuracy of predicting patient pain from electrodermal activity signal (EDA) during standardized Osteoarthritis Research Society International (OARSI) function tests
We will treat the processed EDA signal as a binary classifier (i.e., prediction of pain or no pain at any given moment). The accuracy of these predictions will be calculated against the actual patient-reported pain.
Measured: 0 minutes. Done after all data has been collected.
Percentage of correctly identified pain events (Sensitivity) as measured by the smartwatch (True positive events)
In these tests, we will treat the processed EDA signal as a binary classifier (i.e., prediction of pain or no pain at any given moment). The sensitivity of these predictions will be calculated against the actual patient-reported pain.
Measured: 0 minutes. Done after all data has been collected.
Percentage of correctly identified non-pain events (Specificity) as measured by the smartwatch (True negative non-events)
In these tests, we will treat the processed EDA signal as a binary classifier (i.e., prediction of pain or no pain at any given moment). The specificity of these predictions will be calculated against the actual patient-reported pain.
Measured: 0 minutes. Done after all data has been collected.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2024
- Study startAug 2026 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Osteo Arthritis KneeStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- This preliminary study will look at the predictive effectiveness of the measured biomarker across a small group of patients with osteoarthritis and a small control group of patients without osteoarthritis.
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Connecticut
- Responsible party
- Principal investigator, Peter L. Schilling, Dartmouth-Hitchcock Medical Center
- Investigators
- Peter L Schilling, MD, MS, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06701461
- Sponsor's protocol ID
- STUDY02002493
- Status last verified
- Apr 2025
- First submitted
- 15 Nov 2024
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Posada-Quintero HF, Florian JP, Orjuela-Canon AD, Chon KH. Highly sensitive index of sympathetic activity based on time-frequency spectral analysis of electrodermal activity. Am J Physiol Regul Integr Comp Physiol. 2016 Sep 1;311(3):R582-91. doi: 10.1152/ajpregu.00180.2016. Epub 2016 Jul 20.
PubMed 27440716Posada-Quintero HF, Kong Y, Chon KH. Objective pain stimulation intensity and pain sensation assessment using machine learning classification and regression based on electrodermal activity. Am J Physiol Regul Integr Comp Physiol. 2021 Aug 1;321(2):R186-R196. doi: 10.1152/ajpregu.00094.2021. Epub 2021 Jun 16.
PubMed 34133246
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Osteoarthritic Patient Pain Through Electrodermal Activity Signals
- ClinicalTrials.gov ID
- NCT06701461
- Acronym / sponsor ID
- STUDY02002493
- Conditions
- Osteo Arthritis Knee
- Keywords
- Pain, Electrodermal Activity Signals, Osteoarthritis, Knee
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- University of Connecticut
- Study start
- Aug 2026 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 22 Nov 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.
This pilot study aims to investigate the viability of using a smartwatch-based electrodermal activity (EDA) sensor to capture enough EDA signal to quantitatively assess pain in osteoarthritis subjects and test the feasibility of its methods and procedures for later use in subsequent larger-scale studies.
Detailed description
Chronic pain, a disease in its own right, afflicts one in three adults in the US and poses an enormous economic burden ($560-$635 billion annually), more than heart disease, cancer, and diabetes. To treat pain, doctors often prescribe opioids to suffering patients. Paradoxically, prescription opioid abuse has become a national epidemic, costing $500 billion annually in medical, economic, social, and criminal ramifications. However, the development of effective treatment for chronic pain is hampered by the lack of a reliable biomarker that can quantify the level of pain and detect any attenuation after treatment. This is reflected in the failed statistical significance in many clinical trials of drugs for managing chronic pain (e.g., ONO-2952 and Ibodutant) or a large enrollment number being required to reveal significant but small effects (e.g., 1,798 enrollments for the trial on Renzapride).
Dysfunction of the autonomic nervous system (ANS) has been linked with many chronic pain conditions. The ANS is the primary pathway in brain-gut communication and manifests the body's emotional and psychological states. This makes it particularly relevant to pain, which has a strong emotional component. The ANS includes the sympathetic (SNS) and parasympathetic nervous systems (PNS), and chronic pain conditions reportedly correlate with an unchecked predominance of SNS activity and desensitized PNS. Thus, the PNS and SNS are promising targets for developing sensitive and robust biomarkers for chronic pain.
The investigators will leverage the EmbracePlus smartwatch for the non-invasive quantification of both SNS and PNS activities with time- and frequency-domain analysis of EDA. In this proposed pilot study, the investigators aim to establish whether this biomarker for quantifying pain levels shows promise for osteoarthritis patients when detected through a smartwatch. This is intended to be preliminary work to support a grant application for a more extensive study. In this work, the investigators will collect EDA measurements across up to 15 subjects (2/3 with symptomatic osteoarthritis (Kellgren-Lawrence grade \>= 3) and 1/3 control). Each participant's baseline response will first be measured using a thermal grill (a research device commonly used to induce a painful stimulus without injury). Participants will also report their results using a VAS. Then, Participants will be put through three OARSI standardized functional tests: the 30-second chair test, the 40m fast-paced walk, and the stair climb test. During these tests, subjects will receive a handheld clicker to mark moments of their sharpest pain. The results of each test will then be analyzed through a set of time- and frequency-domain analyses of the recorded bio-signals to extract key parameters and measure how well EDA signal detection captured both sharp and dull pain in subjects.
If effective, this method can be particularly useful. Existing commercial wearable sensors can collect patient data for a week at a time. This would allow for the collection of in-vivo and continuous patient pain data, which could greatly enhance the understanding of patient pain both pre- and post-treatment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This preliminary study will look at the predictive effectiveness of the measured biomarker across a small group of patients with osteoarthritis and a small control group of patients without osteoarthritis.
| Arm | Type | Receives |
|---|---|---|
| Electrodermal Activity Measurement Subjects | Experimental | Device: Electrodermal Activity signalParticipants will have their baseline electrodermal activity (EDA) response to pain measured as well as their EDA response measured while participating in a set of standardized functional tests. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Kellgren-Lawrence Grade >= 3
Key exclusion criteria (19 listed)
- Inflammatory arthropathy (e.g., rheumatoid arthritis), BMI >=35
- Complaints of lower extremity joint pain
- Known diagnosis of knee osteoarthpathy
- Prior history of knee surgery, knee injections, or injury to knee joints (e.g., meniscus tears, ligamentous injuries), BMI >=35
- Subjects with chronic heart problems, including, but not limited to, chronic hypertension, heart palpitations, a weak or irregular heartbeat, or a previous heart attack,
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 |
|---|---|---|
| Electrodermal Activity signalDetermining if the electrodermal activity signals, as measured by the Embrace Plus smartwatch) can be used to measure osteoarthritic patient pain levels. | Device | Electrodermal Activity Measurement Subjects |
Primary outcome
:Difference in pain measurements as reported by the participant via a visual analogue scale versus smartwatch reported electrodermal activity sensors
Time frame: 40 minutes of test time, occurring all in one day.
As a pilot study, the goal is not hypothesis testing but rather examining the feasibility of this approach to measuring patient pain in osteoarthritic patients. Thus, the statistical analysis will be primarily descriptive. The baseline experiment is being done to see whether the smartwatch measurements are at all comparable to prior similar experiments using the thermal grill (Posada-Quintero 2016; Posada-Quintero 2021). For this reason, though not typical for a pilot study, participant responses to the baseline test will use similar analysis to prior electrodermal activity (EDA) based thermal grill studies to see if the smartwatch poses a viable EDA signal collection source. This primarily consists of repeated measures analysis of variance (ANOVA) comparing patient-reported visual analog scale (VAS) scores to EDA output.
Patient-reported pain during standardized Osteoarthritis Research Society International (OARSI) 30-second chair test
Time frame: 5 minutes
Patients will be asked to participate in the standardized OARSI 30-second chair test. During the OARSI functional tests, the timestamps of patient reports of pain will be recorded by the experimenter.
Electrodermal activity (EDA) signals during standardized Osteoarthritis Research Society International (OARSI) 30-second chair test
Time frame: 0 minutes. Concurrent with measurement of patient-reported pain.
A smartwatch will capture the patient's EDA signals during the 30-second chair test
Patient-reported pain during standardized Osteoarthritis Research Society International (OARSI) 40m fast-paced walk test
Time frame: 10 minutes
Patients will be asked to participate in the standardized OARSI 40m fast-paced walk test. During the OARSI functional tests, the timestamps of patient reports of pain will be recorded by the experimenter.
Electrodermal activity (EDA) signals during standardized Osteoarthritis Research Society International (OARSI) 40m fast-paced walk test
Time frame: 0 minutes. Concurrent with measurement of patient-reported pain.
A smartwatch will capture the patient's EDA signals during the 40m fast-paced walk test
Patient-reported pain during standardized Osteoarthritis Research Society International (OARSI) stair climb test
Time frame: 10 minutes
Patients will be asked to participate in the standardized OARSI stair climb test. During the OARSI functional tests, the timestamps of patient reports of pain will be recorded by the experimenter.
Electrodermal activity (EDA) signals during standardized Osteoarthritis Research Society International (OARSI) stair climb test
Time frame: 0 minutes. Concurrent with measurement of patient-reported pain.
A smartwatch will capture the patient's EDA signals during the stair climb test
Accuracy of predicting patient pain from electrodermal activity signal (EDA) during standardized Osteoarthritis Research Society International (OARSI) function tests
Time frame: 0 minutes. Done after all data has been collected.
We will treat the processed EDA signal as a binary classifier (i.e., prediction of pain or no pain at any given moment). The accuracy of these predictions will be calculated against the actual patient-reported pain.
Percentage of correctly identified pain events (Sensitivity) as measured by the smartwatch (True positive events)
Time frame: 0 minutes. Done after all data has been collected.
In these tests, we will treat the processed EDA signal as a binary classifier (i.e., prediction of pain or no pain at any given moment). The sensitivity of these predictions will be calculated against the actual patient-reported pain.
Percentage of correctly identified non-pain events (Specificity) as measured by the smartwatch (True negative non-events)
Time frame: 0 minutes. Done after all data has been collected.
In these tests, we will treat the processed EDA signal as a binary classifier (i.e., prediction of pain or no pain at any given moment). The specificity of these predictions will be calculated against the actual patient-reported pain.
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 6 Mar 2026.
- Background: PubMed 27440716Posada-Quintero HF, Florian JP, Orjuela-Canon AD, Chon KH. Highly sensitive index of sympathetic activity based on time-frequency spectral analysis of electrodermal activity. Am J Physiol Regul Integr Comp Physiol. 2016 Sep 1;311(3):R582-91. doi: 10.1152/ajpregu.00180.2016. Epub 2016 Jul 20.
- Background: PubMed 34133246Posada-Quintero HF, Kong Y, Chon KH. Objective pain stimulation intensity and pain sensation assessment using machine learning classification and regression based on electrodermal activity. Am J Physiol Regul Integr Comp Physiol. 2021 Aug 1;321(2):R186-R196. doi: 10.1152/ajpregu.00094.2021. Epub 2021 Jun 16.
- 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.
Peter L Schilling, MD, MS principal investigator
Dartmouth-Hitchcock Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrodermal Activity signal in people with Osteo Arthritis Knee, run by Dartmouth-Hitchcock Medical Center 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 1 inclusion and 19 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: opening soon, as of the sponsor's last update on 6 Mar 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 Jon M Coordinator, MS (603-650-3306, jon.mikael.anderson@hitchcock.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
:Difference in pain measurements as reported by the participant via a visual analogue scale versus smartwatch reported electrodermal activity sensors (time frame: 40 minutes of test time, occurring all in one day.). The study lists 10 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 NCT06701461, 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 6 Mar 2026.