Pivotal Clinical Trial to Evaluate the Blood Pressure Accuracy of 'CART-I Plus'

NCT05725148 | Completed

• 1 other identifier: SL-BP-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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 '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.

Conditions

Blood Pressure; Hypertension; Hypotension

Keywords

blood pressure

Outcome Measures

Primary Outcomes (1)

• Accuracy of CART-I plus

  Mean error and standard deviation of blood pressure differences between CART-I plus and reference (auscultatory method) readings

  1 day

Study Arms (1)

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

Device: CART-I plus

Interventions

CART-I plus DEVICE

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.

Participants whose SBP and DBP meet the ISO 81060-2:2018 requirements

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• 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

Sponsors & Collaborators

• Sky Labs: lead

Study Sites (1)

Sky Labs

Gyeonggi-do, Pangyo, South Korea

Location

Related Publications (7)

• 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.

  PMID: 23740275 BACKGROUND

• Nachman 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.

  PMID: 32999400 BACKGROUND

• Schoettker 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.

  PMID: 33082436 BACKGROUND

• Watanabe 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.

  PMID: 30062178 BACKGROUND

• Pellaton 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.

  PMID: 31688003 BACKGROUND

• Stergiou 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.

  PMID: 29386350 BACKGROUND

• Tsai 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.

  PMID: 34202597 BACKGROUND

MeSH Terms

Conditions

Hypertension; Hypotension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Seung Woo Park, MD, PhD

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2023
• First Posted: February 13, 2023
• Study Start: September 15, 2022
• Primary Completion: December 23, 2022
• Study Completion: December 23, 2022
• Last Updated: February 13, 2023

Record last verified: 2023-02

Locations

KR (1)