Blood PressureNCT05725148
Pivotal Clinical Trial to Evaluate the Blood Pressure Accuracy of 'CART-I Plus'
A study testing CART-I plus in people with Blood Pressure and Hypertension, run by Sky Labs at 1 site in South Korea.
Trial summary
The goal of this clinical trial is to evaluate how accurately the CART-I plus developed by Sky Labs can measure blood pressure. The primary endpoint of this clinical trial is accuracy (mmHg) of 'CART-I plus' which is obtained by calculating mean error and standard deviation of blood pressure differences between… Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure, Hypertension, Hypotension
- What is being tested?
- CART-I plus
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Sep 2022to 23 Dec 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Those aged 19 or older
- Those who voluntarily decided to participate in this clinical trial and gave written consent to the subject explanation and consent form
- Those who is willing to comply with the clinical trial protocol
Who cannot join
- Those whose sound of fifth Kortkoff phase (K5) is not heard during blood pressure test using an auscultation type sphygmomanometer
- Those with unstable cardiac condition (myocardial infarction, ventricular arrhythmia, atrial fibrillation, premature ventricular contraction, pulmonary embolism 1 week before screening date)
- Those with arm circumference greater than 42 cm (> 42 cm)
- Those with a history of hypersensitivity to clinical trial medical device raw materials (PolyCarbonate, polycarbonate)
- Those with physical restrictions on wearing medical devices for clinical trials (for example, when ring-type clinical trial medical devices cannot be applied due to lack of appropriate ring size or other physical defects)
- Those who are judged to have difficulty collecting normal signals when wearing CART-I plus on a finger other than the thumb and forefinger (for example, if there is no CART-I plus model that fits the subject's finger)
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- Those who is pregnant
- Those who is currently participating in other clinical trials or who have participated in other clinical trials within 30 days of the screening date
- Other cases where the investigator judges that participation in the clinical trial is inappropriate due to ethical reasons or may affect the results of the clinical trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Single-center, Single Group, Pivotal Clinical Trial to Evaluate the Blood Pressure Accuracy of 'CART-I Plus' Compared to the Reference Blood Pressure Reading With an Auscultatory Sphygmomanometer
The goal of this clinical trial is to evaluate how accurately the CART-I plus developed by Sky Labs can measure blood pressure. The primary endpoint of this clinical trial is accuracy (mmHg) of 'CART-I plus' which is obtained by calculating mean error and standard deviation of blood pressure differences between 'CART-I plus' and the gold standard for non-invasive method, auscultatory method. The reference readings are taken by auscultatory method using a sphygmomanometer and a stethoscope. The mean errors and standard deviations are calculated both sample- and subject-wise.
Read the detailed description
According to the World Health Organization (WHO), hypertension is one of the major risk factors for death worldwide. The global adult population with hypertension is approximately 113 million, with an estimated prevalence of 18-27%. Hypertension is associated with stroke and other cardiovascular diseases, thus early detection and treatment critical. National guidelines of the Japanese, European, and American Hypertension Society recommend that home blood pressure and clinic blood pressure test results be applied together when diagnosing hypertension, emphasizing the importance of blood pressure monitoring in daily life. In addition, according to the Ohasama cohort study and the Finn-Home study, blood pressure measured in daily life was more predictive of cardiovascular disease than the office blood pressure.
There are invasive and non-invasive methods for blood pressure monitoring. The invasive method measures blood pressure using a pressure sensor by inserting a catheter into a blood vessel, and the non-invasive method measures blood pressure by sensing sound or vibration while applying pressure using a cuff. Invasive blood pressure tests can continuously measure blood pressure and are accurate, but there is a high risk of side effects such as distal ischemia, bleeding, thrombosis, infection, etc and is not available for a daily life. Non-invasive blood pressure test methods such as auscultatory measurement and oscillometric method are simpler than invasive methods, but it has limitations in measuring blood pressure continuously and observing long-term variations.
The photoplethysmography (PPG) method makes it possible to measure blood pressure without a cuff, enabling people to check and monitor blood pressure in daily life for a long time. It has been reported that the wavelength and amplitude of the PDW signal collected from the finger show a high correlation (0.92) with the PDP signal collected from the wrist. This suggests that the blood pressure accuracy of measuring blood pressure with PPG signals collected from the finger will not differ significantly from that measured from the wrist.
Sky Labs has developed 'CART-I plus' that can measure blood pressure in daily life without a cuff. 'CART-I plus' is a ring-type device that applies the principle of PPG technology to measure blood flow through finger veins. This clinical trial was designed in accordance with the ISO 81060-2:2018 standard to evaluate the accuracy of blood pressure estimated by 'CART-I plus'.
- Conditions
- Blood Pressure, Hypertension, Hypotension
- Being tested
- CART-I plus
- Keywords
- blood pressure
- Medical subject headings
- Hypertension, Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CART-I plusDevice
CART-I plus is a ring-type medical device that continuously monitors Atrial Fibrillation, heart rate, oxygen saturation, and blood pressure using PPG and ECG signals.
| Study group | Role | What they receive |
|---|---|---|
| Participants whose SBP and DBP meet the ISO 81060-2:2018 requirements | Experimental | Each set of blood pressure tests is performed simultaneously. A cuff is worn on the right (or left) arm to check the blood pressure by auscultation, while 'CART-I plus' is worn on the finger of the opposite arm to check the blood pressure. At this time, the blood pressure test using an auscultation method is performed by two investigators simultaneously, and the blood pressure test using 'CART-I plus' is performed by the participants themselves Receives: Device: CART-I plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of CART-I plus
Mean error and standard deviation of blood pressure differences between CART-I plus and reference (auscultatory method) readings
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2023
- Study start15 Sep 2022
- Primary completion23 Dec 2022
- Study completion23 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sky Labs
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Seung Woo Park, MD, PhD, Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05725148
- Sponsor's protocol ID
- SL-BP-01
- Status last verified
- Feb 2023
- First submitted
- 2 Feb 2023
- Last updated
- 13 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The investigators would probably share the results showing the level of agreement between the two measurement methods after deidentification of participant data
Publications
Ruiz-Rodriguez JC, Ruiz-Sanmartin A, Ribas V, Caballero J, Garcia-Roche A, Riera J, Nuvials X, de Nadal M, de Sola-Morales O, Serra J, Rello J. Innovative continuous non-invasive cuffless blood pressure monitoring based on photoplethysmography technology. Intensive Care Med. 2013 Sep;39(9):1618-25. doi: 10.1007/s00134-013-2964-2. Epub 2013 Jun 6.
PubMed 23740275Nachman D, Gepner Y, Goldstein N, Kabakov E, Ishay AB, Littman R, Azmon Y, Jaffe E, Eisenkraft A. Comparing blood pressure measurements between a photoplethysmography-based and a standard cuff-based manometry device. Sci Rep. 2020 Sep 30;10(1):16116. doi: 10.1038/s41598-020-73172-3.
PubMed 32999400Schoettker P, Degott J, Hofmann G, Proenca M, Bonnier G, Lemkaddem A, Lemay M, Schorer R, Christen U, Knebel JF, Wuerzner A, Burnier M, Wuerzner G. Blood pressure measurements with the OptiBP smartphone app validated against reference auscultatory measurements. Sci Rep. 2020 Oct 20;10(1):17827. doi: 10.1038/s41598-020-74955-4.
PubMed 33082436Watanabe N, Bando YK, Kawachi T, Yamakita H, Futatsuyama K, Honda Y, Yasui H, Nishimura K, Kamihara T, Okumura T, Ishii H, Kondo T, Murohara T. Development and Validation of a Novel Cuff-Less Blood Pressure Monitoring Device. JACC Basic Transl Sci. 2017 Dec 25;2(6):631-642. doi: 10.1016/j.jacbts.2017.07.015. eCollection 2017 Dec.
PubMed 30062178Pellaton C, Vybornova A, Fallet S, Marques L, Grossenbacher O, De Marco B, Chapuis V, Bertschi M, Alpert BS, Sola J. Accuracy testing of a new optical device for noninvasive estimation of systolic and diastolic blood pressure compared to intra-arterial measurements. Blood Press Monit. 2020 Apr;25(2):105-109. doi: 10.1097/MBP.0000000000000421.
PubMed 31688003Stergiou GS, Alpert B, Mieke S, Asmar R, Atkins N, Eckert S, Frick G, Friedman B, Grassl T, Ichikawa T, Ioannidis JP, Lacy P, McManus R, Murray A, Myers M, Palatini P, Parati G, Quinn D, Sarkis J, Shennan A, Usuda T, Wang J, Wu CO, O'Brien E. A Universal Standard for the Validation of Blood Pressure Measuring Devices: Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Collaboration Statement. Hypertension. 2018 Mar;71(3):368-374. doi: 10.1161/HYPERTENSIONAHA.117.10237. Epub 2018 Jan 31.
PubMed 29386350Tsai PY, Huang CH, Guo JW, Li YC, Wu AA, Lin HJ, Wang TD. Coherence between Decomposed Components of Wrist and Finger PPG Signals by Imputing Missing Features and Resolving Ambiguous Features. Sensors (Basel). 2021 Jun 24;21(13):4315. doi: 10.3390/s21134315.
PubMed 34202597
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Single-center, Single Group, Pivotal Clinical Trial to Evaluate the Blood Pressure Accuracy of 'CART-I Plus' Compared to the Reference Blood Pressure Reading With an Auscultatory Sphygmomanometer
- ClinicalTrials.gov ID
- NCT05725148
- Acronym / sponsor ID
- SL-BP-01
- Conditions
- Blood Pressure, Hypertension, Hypotension
- Keywords
- blood pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Sky LabsIndustry (pharma, biotech, devices)
- Study start
- 15 Sep 2022 (actual)
- Primary completion
- 23 Dec 2022 (actual)
- Study completion
- 23 Dec 2022 (actual)
- First posted
- 13 Feb 2023 (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 clinical trial is to evaluate how accurately the CART-I plus developed by Sky Labs can measure blood pressure. The primary endpoint of this clinical trial is accuracy (mmHg) of 'CART-I plus' which is obtained by calculating mean error and standard deviation of blood pressure differences between 'CART-I plus' and the gold standard for non-invasive method, auscultatory method. The reference readings are taken by auscultatory method using a sphygmomanometer and a stethoscope. The mean errors and standard deviations are calculated both sample- and subject-wise.
Detailed description
According to the World Health Organization (WHO), hypertension is one of the major risk factors for death worldwide. The global adult population with hypertension is approximately 113 million, with an estimated prevalence of 18-27%. Hypertension is associated with stroke and other cardiovascular diseases, thus early detection and treatment critical. National guidelines of the Japanese, European, and American Hypertension Society recommend that home blood pressure and clinic blood pressure test results be applied together when diagnosing hypertension, emphasizing the importance of blood pressure monitoring in daily life. In addition, according to the Ohasama cohort study and the Finn-Home study, blood pressure measured in daily life was more predictive of cardiovascular disease than the office blood pressure.
There are invasive and non-invasive methods for blood pressure monitoring. The invasive method measures blood pressure using a pressure sensor by inserting a catheter into a blood vessel, and the non-invasive method measures blood pressure by sensing sound or vibration while applying pressure using a cuff. Invasive blood pressure tests can continuously measure blood pressure and are accurate, but there is a high risk of side effects such as distal ischemia, bleeding, thrombosis, infection, etc and is not available for a daily life. Non-invasive blood pressure test methods such as auscultatory measurement and oscillometric method are simpler than invasive methods, but it has limitations in measuring blood pressure continuously and observing long-term variations.
The photoplethysmography (PPG) method makes it possible to measure blood pressure without a cuff, enabling people to check and monitor blood pressure in daily life for a long time. It has been reported that the wavelength and amplitude of the PDW signal collected from the finger show a high correlation (0.92) with the PDP signal collected from the wrist. This suggests that the blood pressure accuracy of measuring blood pressure with PPG signals collected from the finger will not differ significantly from that measured from the wrist.
Sky Labs has developed 'CART-I plus' that can measure blood pressure in daily life without a cuff. 'CART-I plus' is a ring-type device that applies the principle of PPG technology to measure blood flow through finger veins. This clinical trial was designed in accordance with the ISO 81060-2:2018 standard to evaluate the accuracy of blood pressure estimated by 'CART-I plus'.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants whose SBP and DBP meet the ISO 81060-2:2018 requirements | Experimental | Device: CART-I plusEach set of blood pressure tests is performed simultaneously. A cuff is worn on the right (or left) arm to check the blood pressure by auscultation, while 'CART-I plus' is worn on the finger of the opposite arm to check the blood pressure. At this time, the blood pressure test using an auscultation method is performed by two investigators simultaneously, and the blood pressure test using 'CART-I plus' is performed by the participants themselves |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Those aged 19 or older
- Those who voluntarily decided to participate in this clinical trial and gave written consent to the subject explanation and consent form
- Those who is willing to comply with the clinical trial protocol
Key exclusion criteria (9 listed)
- Those whose sound of fifth Kortkoff phase (K5) is not heard during blood pressure test using an auscultation type sphygmomanometer
- Those with unstable cardiac condition (myocardial infarction, ventricular arrhythmia, atrial fibrillation, premature ventricular contraction, pulmonary embolism 1 week before screening date)
- Those with arm circumference greater than 42 cm (> 42 cm)
- Those with a history of hypersensitivity to clinical trial medical device raw materials (PolyCarbonate, polycarbonate)
- Those with physical restrictions on wearing medical devices for clinical trials (for example, when ring-type clinical trial medical devices cannot be applied due to lack of appropriate ring size or other physical defects)
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 |
|---|---|---|
| CART-I plusCART-I plus is a ring-type medical device that continuously monitors Atrial Fibrillation, heart rate, oxygen saturation, and blood pressure using PPG and ECG signals. | Device | Participants whose SBP and DBP meet the ISO 81060-2:2018 requirements |
Primary outcome
Accuracy of CART-I plus
Time frame: 1 day
Mean error and standard deviation of blood pressure differences between CART-I plus and reference (auscultatory method) readings
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 13 Feb 2023.
- Background: PubMed 23740275Ruiz-Rodriguez JC, Ruiz-Sanmartin A, Ribas V, Caballero J, Garcia-Roche A, Riera J, Nuvials X, de Nadal M, de Sola-Morales O, Serra J, Rello J. Innovative continuous non-invasive cuffless blood pressure monitoring based on photoplethysmography technology. Intensive Care Med. 2013 Sep;39(9):1618-25. doi: 10.1007/s00134-013-2964-2. Epub 2013 Jun 6.
- Background: PubMed 32999400Nachman D, Gepner Y, Goldstein N, Kabakov E, Ishay AB, Littman R, Azmon Y, Jaffe E, Eisenkraft A. Comparing blood pressure measurements between a photoplethysmography-based and a standard cuff-based manometry device. Sci Rep. 2020 Sep 30;10(1):16116. doi: 10.1038/s41598-020-73172-3.
- Background: PubMed 33082436Schoettker P, Degott J, Hofmann G, Proenca M, Bonnier G, Lemkaddem A, Lemay M, Schorer R, Christen U, Knebel JF, Wuerzner A, Burnier M, Wuerzner G. Blood pressure measurements with the OptiBP smartphone app validated against reference auscultatory measurements. Sci Rep. 2020 Oct 20;10(1):17827. doi: 10.1038/s41598-020-74955-4.
- Background: PubMed 30062178Watanabe N, Bando YK, Kawachi T, Yamakita H, Futatsuyama K, Honda Y, Yasui H, Nishimura K, Kamihara T, Okumura T, Ishii H, Kondo T, Murohara T. Development and Validation of a Novel Cuff-Less Blood Pressure Monitoring Device. JACC Basic Transl Sci. 2017 Dec 25;2(6):631-642. doi: 10.1016/j.jacbts.2017.07.015. eCollection 2017 Dec.
- Background: PubMed 31688003Pellaton C, Vybornova A, Fallet S, Marques L, Grossenbacher O, De Marco B, Chapuis V, Bertschi M, Alpert BS, Sola J. Accuracy testing of a new optical device for noninvasive estimation of systolic and diastolic blood pressure compared to intra-arterial measurements. Blood Press Monit. 2020 Apr;25(2):105-109. doi: 10.1097/MBP.0000000000000421.
- Background: PubMed 29386350Stergiou GS, Alpert B, Mieke S, Asmar R, Atkins N, Eckert S, Frick G, Friedman B, Grassl T, Ichikawa T, Ioannidis JP, Lacy P, McManus R, Murray A, Myers M, Palatini P, Parati G, Quinn D, Sarkis J, Shennan A, Usuda T, Wang J, Wu CO, O'Brien E. A Universal Standard for the Validation of Blood Pressure Measuring Devices: Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Collaboration Statement. Hypertension. 2018 Mar;71(3):368-374. doi: 10.1161/HYPERTENSIONAHA.117.10237. Epub 2018 Jan 31.
- Background: PubMed 34202597Tsai PY, Huang CH, Guo JW, Li YC, Wu AA, Lin HJ, Wang TD. Coherence between Decomposed Components of Wrist and Finger PPG Signals by Imputing Missing Features and Resolving Ambiguous Features. Sensors (Basel). 2021 Jun 24;21(13):4315. doi: 10.3390/s21134315.
- Individual participant dataSharing planned: Undecided. The investigators would probably share the results showing the level of agreement between the two measurement methods after deidentification of participant data
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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.
Seung Woo Park, MD, PhD principal investigator
Samsung 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 CART-I plus in people with Blood Pressure and Hypertension, run by Sky Labs at 1 site in South Korea.
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 9 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 13 Feb 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 South Korea. 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?
Accuracy of CART-I plus (time frame: 1 day). 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 NCT05725148, which also lists 7 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 13 Feb 2023.