EpilepsySeizeIT2NCT04284072
Clinical Scenarios for Long-term Monitoring of Epileptic Seizures With a Wearable Biopotential Technology
A study testing Sensor Dot in people with Epilepsy, run by Universitaire Ziekenhuizen KU Leuven at 7 sites in 5 countries.
Trial summary
Clinically validate a biopotential and motion recording wearable device (Byteflies Sensor Dot) for detection of epileptic seizures in the epilepsy monitoring unit (EMU) and at home. Read more about this study
- Who is it for?
- Ages 4 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- Sensor Dot
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 496 participants
- Where
- 7 sitesin 5 countries
- Study dates
- 22 Jun 2020to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects (4+ years old) with refractory epilepsy who are admitted to the hospital for clinically-indicated long-term video-EEG assessment or presurgical evaluation, and a high likelihood of experiencing seizures during the EMU Phase
- For subjects continuing into the Home Phase: successful recording of their habitual seizures with Sensor Dot during the EMU Phase
- For subjects continuing into the Home Phase: the ability to keep an e-diary
Who cannot join
- Known allergies to any of the biopotential electrodes or adhesives used as part of the study protocol
- Having an implanted device, such as (but not limited to) a pacemaker, cardioverter defibrillator (ICD), and/or neural stimulation device because Sensor Dot contains magnets that could interfere with the operation of these devices
- Women who are pregnant
Trial locations and contacts
7 sites in 5 countries.
7 sites in 5 countries
Germany2 sites
Department of Epileptology and Neurology
Aachen
Epilepsy Center, University Medical Center, Freiburg University
Freiburg im Breisgau
United Kingdom2 sites
Division of Neuroscience, King's College London
London
Nuffield Department of Clinical Neurosciences, Oxford University Hospital
Oxford
Belgium1 site
University Hospitals Leuven, department of Neurology
Leuven, 3000
Sweden1 site
Department of Clinical Neuroscience, Karolinska Institute
Stockholm
About this study
Official title: A Multicenter Study to Examine Clinical Scenarios for Long-term Monitoring of Epileptic Seizures With a Wearable Biopotential Technology
Clinically validate a biopotential and motion recording wearable device (Byteflies Sensor Dot) for detection of epileptic seizures in the epilepsy monitoring unit (EMU) and at home.
Read the detailed description
Subjects with refractory epilepsy who are admitted to the Epilepsy Monitoring Unit (EMU) for clinically-indicated long-term video-EEG assessment will be simultaneously monitored with Sensor Dots to record electroencephalographic (EEG), electrocardiographic (ECG), electromyographic (EMG), and motion signals.
A subset of subjects will continue using Sensor Dot devices at home (Home Phase) after completing the EMU Phase.
The data recorded by Sensor Dots will be used to: 1) annotate epileptic seizures, which will be compared to the annotations made as part of routine EMU monitoring and seizure diaries kept at home, and 2) to develop seizure detection algorithms. The data collected as part of this study will not be used to influence clinical decision making.
- Conditions
- Epilepsy
- Being tested
- Sensor Dot
- Keywords
- Seizure detection, Wearable, Epilepsy, Seizure, Sensor Dot
- Medical subject headings
- Epilepsy, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sensor DotDevice
Multimodal (EEG, ECG, EMG and motion) seizure monitoring with Sensor Dot to complement EMU-based video-EEG monitoring (EMU Phase), and optional home-based seizure diary logging (Home Phase).
| Study group | Role | What they receive |
|---|---|---|
| All subjects | Experimental | Single arm study with a device intervention for epileptic seizure monitoring in subjects with refractory focal impaired awareness, tonic-clonic, and/or typical absence seizures. Receives: Device: Sensor Dot |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of typical absence seizure annotations derived from Sensor Dot data collected during the EMU Phase against annotations derived from video-EEG equipment during wakefulness
F1-score as determined by expert reviewers
Measured: up to two weeks
Comparison of typical absence seizure annotations derived from Sensor Dot data collected during the EMU Phase against annotations derived from video-EEG equipment during sleep
F1-score as determined by expert reviewers
Measured: up to two weeks
Comparison of focal impaired awareness seizure annotations derived from Sensor Dot data collected during the EMU Phase against annotations derived from video-EEG equipment during wakefulness
F1-score as determined by expert reviewers
Measured: up to two weeks
Comparison of focal impaired awareness seizure annotations derived from Sensor Dot data collected during the EMU Phase against annotations derived from video-EEG equipment during sleep
F1-score as determined by expert reviewers
Measured: up to two weeks
Comparison of tonic-clonic seizure annotations derived from Sensor Dot data collected during the EMU Phase against annotations derived from video-EEG equipment during wakefulness
F1-score as determined by expert reviewers
Measured: up to two weeks
Comparison of tonic-clonic seizure annotations derived from Sensor Dot data collected during the EMU Phase against annotations derived from video-EEG equipment during sleep
F1-score as determined by expert reviewers
Measured: up to two weeks
Secondary outcomes (6)
Sensor Dot usability
We will assess the usability of the device as perceived by users (patients and healthcare personnel) via surveys
Measured: up to two weeks
To assess seizure duration
From the Sensor Dot data, we will be able to assess seizure duration
Measured: up to two weeks
To assess the usability of the seizure e-diary
We will asses usability of the electronic seizure diary
Measured: up to two weeks
To evaluate the accuracy of automated seizure detection algorithms
We will use the collected data and seizure annotations to develop algorithms to automatically detect epileptic seizures. We plan to evaluate how accurate these new automated seizure detection algorithms are.
Measured: 2 years
Comparison of seizure annotations derived from Sensor Dot data collected during the Home Phase against seizure diary annotations
Accuracy as determined by expert reviewers
Measured: up to 2 weeks
Sensor Dot Performance
We will assess the technical performance of the device by comparing the actual length of recorded data against the expected recording length, and what percentage of the data is high quality enough to make seizure annotations.
Measured: up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2020
- Study start22 Jun 2020
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- Sequential
- Masking
- None (open label)
- Enrolment
- 496 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- University of Freiburg, King's College London, Oxford University Hospitals NHS Trust, University of Coimbra, Karolinska Institutet, RWTH Aachen University, UCB Pharma, Byteflies, Helpilepsy
- Responsible party
- Sponsor
- Investigators
- Wim Van Paesschen, MD, PhD, Principal investigator, UZ Leuven and KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04284072
- Sponsor's protocol ID
- S63631
- Acronym
- SeizeIT2
- Status last verified
- May 2022
- First submitted
- 17 Feb 2020
- Last updated
- 8 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to share the individual biosignals (EEG, EMG, ECG and movement) and 24-channel seizure-annotated EEG data, de-identified demographic and epilepsy-related data two years after the finish of the study (1-1-2024) upon request to researchers who provide a methodologically sound proposal.
Publications
Fisher RS, Acevedo C, Arzimanoglou A, Bogacz A, Cross JH, Elger CE, Engel J Jr, Forsgren L, French JA, Glynn M, Hesdorffer DC, Lee BI, Mathern GW, Moshe SL, Perucca E, Scheffer IE, Tomson T, Watanabe M, Wiebe S. ILAE official report: a practical clinical definition of epilepsy. Epilepsia. 2014 Apr;55(4):475-82. doi: 10.1111/epi.12550. Epub 2014 Apr 14.
PubMed 24730690Sander JW. The epidemiology of epilepsy revisited. Curr Opin Neurol. 2003 Apr;16(2):165-70. doi: 10.1097/01.wco.0000063766.15877.8e.
PubMed 12644744Kwan P, Brodie MJ. Early identification of refractory epilepsy. N Engl J Med. 2000 Feb 3;342(5):314-9. doi: 10.1056/NEJM200002033420503.
PubMed 10660394Elger CE, Hoppe C. Diagnostic challenges in epilepsy: seizure under-reporting and seizure detection. Lancet Neurol. 2018 Mar;17(3):279-288. doi: 10.1016/S1474-4422(18)30038-3.
PubMed 29452687Hoppe C, Poepel A, Elger CE. Epilepsy: accuracy of patient seizure counts. Arch Neurol. 2007 Nov;64(11):1595-9. doi: 10.1001/archneur.64.11.1595.
PubMed 17998441Kurada AV, Srinivasan T, Hammond S, Ulate-Campos A, Bidwell J. Seizure detection devices for use in antiseizure medication clinical trials: A systematic review. Seizure. 2019 Mar;66:61-69. doi: 10.1016/j.seizure.2019.02.007. Epub 2019 Feb 13.
PubMed 30802844Bidwell J, Khuwatsamrit T, Askew B, Ehrenberg JA, Helmers S. Seizure reporting technologies for epilepsy treatment: A review of clinical information needs and supporting technologies. Seizure. 2015 Nov;32:109-17. doi: 10.1016/j.seizure.2015.09.006. Epub 2015 Sep 18.
PubMed 26552573Beniczky S, Ryvlin P. Standards for testing and clinical validation of seizure detection devices. Epilepsia. 2018 Jun;59 Suppl 1:9-13. doi: 10.1111/epi.14049.
PubMed 29873827Szabo CA, Morgan LC, Karkar KM, Leary LD, Lie OV, Girouard M, Cavazos JE. Electromyography-based seizure detector: Preliminary results comparing a generalized tonic-clonic seizure detection algorithm to video-EEG recordings. Epilepsia. 2015 Sep;56(9):1432-7. doi: 10.1111/epi.13083. Epub 2015 Jul 20.
PubMed 26190150Beniczky S, Conradsen I, Wolf P. Detection of convulsive seizures using surface electromyography. Epilepsia. 2018 Jun;59 Suppl 1:23-29. doi: 10.1111/epi.14048.
PubMed 29873829Beniczky S, Polster T, Kjaer TW, Hjalgrim H. Detection of generalized tonic-clonic seizures by a wireless wrist accelerometer: a prospective, multicenter study. Epilepsia. 2013 Apr;54(4):e58-61. doi: 10.1111/epi.12120. Epub 2013 Feb 8.
PubMed 23398578Kjaer TW, Sorensen HBD, Groenborg S, Pedersen CR, Duun-Henriksen J. Detection of Paroxysms in Long-Term, Single-Channel EEG-Monitoring of Patients with Typical Absence Seizures. IEEE J Transl Eng Health Med. 2017 Jan 9;5:2000108. doi: 10.1109/JTEHM.2017.2649491. eCollection 2017.
PubMed 29018634Zibrandtsen IC, Kidmose P, Christensen CB, Kjaer TW. Ear-EEG detects ictal and interictal abnormalities in focal and generalized epilepsy - A comparison with scalp EEG monitoring. Clin Neurophysiol. 2017 Dec;128(12):2454-2461. doi: 10.1016/j.clinph.2017.09.115. Epub 2017 Oct 12.
PubMed 29096220Gu Y, Cleeren E, Dan J, Claes K, Van Paesschen W, Van Huffel S, Hunyadi B. Comparison between Scalp EEG and Behind-the-Ear EEG for Development of a Wearable Seizure Detection System for Patients with Focal Epilepsy. Sensors (Basel). 2017 Dec 23;18(1):29. doi: 10.3390/s18010029.
PubMed 29295522Dan J, Weckhuysen D, Cleeren E, Van Paesschen W, Vandendriessche B. Technical validation of Sensor Dot: a wearable for ambulatory monitoring of epileptic seizures. 2nd International Congress on mobile devices and seizure detection in epilepsy; Lausanne, Switzerland, 2019.
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Study to Examine Clinical Scenarios for Long-term Monitoring of Epileptic Seizures With a Wearable Biopotential Technology
- ClinicalTrials.gov ID
- NCT04284072
- Acronym / sponsor ID
- SeizeIT2 / S63631
- Conditions
- Epilepsy
- Keywords
- Seizure detection, Wearable, Epilepsy, Seizure, Sensor Dot
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 496 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- University of Freiburg, King's College London, Oxford University Hospitals NHS Trust, University of Coimbra, Karolinska Institutet, RWTH Aachen University, UCB Pharma, Byteflies, Helpilepsy
- Study start
- 22 Jun 2020 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 25 Feb 2020 (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.
Clinically validate a biopotential and motion recording wearable device (Byteflies Sensor Dot) for detection of epileptic seizures in the epilepsy monitoring unit (EMU) and at home.
Detailed description
Subjects with refractory epilepsy who are admitted to the Epilepsy Monitoring Unit (EMU) for clinically-indicated long-term video-EEG assessment will be simultaneously monitored with Sensor Dots to record electroencephalographic (EEG), electrocardiographic (ECG), electromyographic (EMG), and motion signals.
A subset of subjects will continue using Sensor Dot devices at home (Home Phase) after completing the EMU Phase.
The data recorded by Sensor Dots will be used to: 1) annotate epileptic seizures, which will be compared to the annotations made as part of routine EMU monitoring and seizure diaries kept at home, and 2) to develop seizure detection algorithms. The data collected as part of this study will not be used to influence clinical decision making.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All subjects | Experimental | Device: Sensor DotSingle arm study with a device intervention for epileptic seizure monitoring in subjects with refractory focal impaired awareness, tonic-clonic, and/or typical absence seizures. |
Who may qualify
- Ages
- 4 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects (4+ years old) with refractory epilepsy who are admitted to the hospital for clinically-indicated long-term video-EEG assessment or presurgical evaluation, and a high likelihood of experiencing seizures during the EMU Phase
- For subjects continuing into the Home Phase: successful recording of their habitual seizures with Sensor Dot during the EMU Phase
- For subjects continuing into the Home Phase: the ability to keep an e-diary
Key exclusion criteria (3 listed)
- Known allergies to any of the biopotential electrodes or adhesives used as part of the study protocol
- Having an implanted device, such as (but not limited to) a pacemaker, cardioverter defibrillator (ICD), and/or neural stimulation device because Sensor Dot contains magnets that could interfere with the operation of these devices
- Women who are pregnant
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 |
|---|---|---|
| Sensor DotMultimodal (EEG, ECG, EMG and motion) seizure monitoring with Sensor Dot to complement EMU-based video-EEG monitoring (EMU Phase), and optional home-based seizure diary logging (Home Phase). | Device | All subjects |
Primary outcome
Comparison of typical absence seizure annotations derived from Sensor Dot data collected during the EMU Phase against annotations derived from video-EEG equipment during wakefulness
Time frame: up to two weeks
F1-score as determined by expert reviewers
Comparison of typical absence seizure annotations derived from Sensor Dot data collected during the EMU Phase against annotations derived from video-EEG equipment during sleep
Time frame: up to two weeks
F1-score as determined by expert reviewers
Comparison of focal impaired awareness seizure annotations derived from Sensor Dot data collected during the EMU Phase against annotations derived from video-EEG equipment during wakefulness
Time frame: up to two weeks
F1-score as determined by expert reviewers
Comparison of focal impaired awareness seizure annotations derived from Sensor Dot data collected during the EMU Phase against annotations derived from video-EEG equipment during sleep
Time frame: up to two weeks
F1-score as determined by expert reviewers
Comparison of tonic-clonic seizure annotations derived from Sensor Dot data collected during the EMU Phase against annotations derived from video-EEG equipment during wakefulness
Time frame: up to two weeks
F1-score as determined by expert reviewers
Comparison of tonic-clonic seizure annotations derived from Sensor Dot data collected during the EMU Phase against annotations derived from video-EEG equipment during sleep
Time frame: up to two weeks
F1-score as determined by expert reviewers
6 secondary outcomes
Sensor Dot usability
Time frame: up to two weeks
To assess seizure duration
Time frame: up to two weeks
To assess the usability of the seizure e-diary
Time frame: up to two weeks
To evaluate the accuracy of automated seizure detection algorithms
Time frame: 2 years
Comparison of seizure annotations derived from Sensor Dot data collected during the Home Phase against seizure diary annotations
Time frame: up to 2 weeks
Sensor Dot Performance
Time frame: up to 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2022.
- Background: PubMed 24730690Fisher RS, Acevedo C, Arzimanoglou A, Bogacz A, Cross JH, Elger CE, Engel J Jr, Forsgren L, French JA, Glynn M, Hesdorffer DC, Lee BI, Mathern GW, Moshe SL, Perucca E, Scheffer IE, Tomson T, Watanabe M, Wiebe S. ILAE official report: a practical clinical definition of epilepsy. Epilepsia. 2014 Apr;55(4):475-82. doi: 10.1111/epi.12550. Epub 2014 Apr 14.
- Background: PubMed 12644744Sander JW. The epidemiology of epilepsy revisited. Curr Opin Neurol. 2003 Apr;16(2):165-70. doi: 10.1097/01.wco.0000063766.15877.8e.
- Background: PubMed 10660394Kwan P, Brodie MJ. Early identification of refractory epilepsy. N Engl J Med. 2000 Feb 3;342(5):314-9. doi: 10.1056/NEJM200002033420503.
- Background: PubMed 29452687Elger CE, Hoppe C. Diagnostic challenges in epilepsy: seizure under-reporting and seizure detection. Lancet Neurol. 2018 Mar;17(3):279-288. doi: 10.1016/S1474-4422(18)30038-3.
- Background: PubMed 17998441Hoppe C, Poepel A, Elger CE. Epilepsy: accuracy of patient seizure counts. Arch Neurol. 2007 Nov;64(11):1595-9. doi: 10.1001/archneur.64.11.1595.
- Background: PubMed 30802844Kurada AV, Srinivasan T, Hammond S, Ulate-Campos A, Bidwell J. Seizure detection devices for use in antiseizure medication clinical trials: A systematic review. Seizure. 2019 Mar;66:61-69. doi: 10.1016/j.seizure.2019.02.007. Epub 2019 Feb 13.
- Background: PubMed 26552573Bidwell J, Khuwatsamrit T, Askew B, Ehrenberg JA, Helmers S. Seizure reporting technologies for epilepsy treatment: A review of clinical information needs and supporting technologies. Seizure. 2015 Nov;32:109-17. doi: 10.1016/j.seizure.2015.09.006. Epub 2015 Sep 18.
- Background: PubMed 29873827Beniczky S, Ryvlin P. Standards for testing and clinical validation of seizure detection devices. Epilepsia. 2018 Jun;59 Suppl 1:9-13. doi: 10.1111/epi.14049.
- Background: PubMed 26190150Szabo CA, Morgan LC, Karkar KM, Leary LD, Lie OV, Girouard M, Cavazos JE. Electromyography-based seizure detector: Preliminary results comparing a generalized tonic-clonic seizure detection algorithm to video-EEG recordings. Epilepsia. 2015 Sep;56(9):1432-7. doi: 10.1111/epi.13083. Epub 2015 Jul 20.
- Background: PubMed 29873829Beniczky S, Conradsen I, Wolf P. Detection of convulsive seizures using surface electromyography. Epilepsia. 2018 Jun;59 Suppl 1:23-29. doi: 10.1111/epi.14048.
- Background: PubMed 23398578Beniczky S, Polster T, Kjaer TW, Hjalgrim H. Detection of generalized tonic-clonic seizures by a wireless wrist accelerometer: a prospective, multicenter study. Epilepsia. 2013 Apr;54(4):e58-61. doi: 10.1111/epi.12120. Epub 2013 Feb 8.
- Background: PubMed 29018634Kjaer TW, Sorensen HBD, Groenborg S, Pedersen CR, Duun-Henriksen J. Detection of Paroxysms in Long-Term, Single-Channel EEG-Monitoring of Patients with Typical Absence Seizures. IEEE J Transl Eng Health Med. 2017 Jan 9;5:2000108. doi: 10.1109/JTEHM.2017.2649491. eCollection 2017.
- EIT Health website referring to our SeizeIT2 projectLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. We plan to share the individual biosignals (EEG, EMG, ECG and movement) and 24-channel seizure-annotated EEG data, de-identified demographic and epilepsy-related data two years after the finish of the study (1-1-2024) upon request to researchers who provide a methodologically sound proposal.
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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.
Wim Van Paesschen, MD, PhD principal investigator
UZ Leuven and KU Leuven
7 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sensor Dot in people with Epilepsy, run by Universitaire Ziekenhuizen KU Leuven at 7 sites in 5 countries.
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 3 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: finished, as of the sponsor's last update on 8 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Germany, United Kingdom, Belgium, Portugal, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of typical absence seizure annotations derived from Sensor Dot data collected during the EMU Phase against annotations derived from video-EEG equipment during wakefulness (time frame: up to two weeks). The study lists 6 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 NCT04284072, which also lists 19 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 8 Nov 2022.