ClinicalTrials.gg
RecruitingNCT06084065Updated Oct 16, 2023

Feasibility and Effectiveness of a Ring-type Blood Pressure Measurement Device

An interventional study of CART-I Plus in Hypertension, Blood Pressure and Systolic Hypertension, sponsored by Seoul National University Hospital. Recruiting at 1 site in Korea, Republic of. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-10-16.

Primary conditionEssential HypertensionRegistry: HypertensionReclassifiedWhy we changed it
Registry
Hypertension — the first condition term the registry derived for this study.
ClinicalTrials.gg
Essential Hypertension
Why
  1. The study's listed conditions name Essential Hypertension, a narrower term within Hypertension.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Primary completion was expected by Dec 2023, 2 years 10 months ago, but the record still lists the study as recruiting.
  • Started Jul 2023; still recruiting 3 years 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study summary

The goal of this clinical trial is to evaluate the feasibility and effectiveness of a ring-type blood pressure measurement device compared to a 24-hour ambulatory blood pressure monitoring device in patients with hypertension or suspected hypertension. The main question it aims to answer is whether the 24-hour blood pressure measurement accuracy of the ring-type blood pressure monitor is similar to that of the 24-hour ambulatory blood pressure monitor. To participate, subjects must wear a ring blood pressure monitor and an ambulatory blood pressure monitor simultaneously for 24 hours.

02

Conditions studied

  • Hypertension
  • Blood Pressure
  • Systolic Hypertension
  • Diastolic Hypertension
  • Essential Hypertension
  • Obstructive Sleep Apnea
  • Prehypertension
03

In context

Essential Hypertension Reclassified

478 studies on the registry are indexed under Essential Hypertension; 74 are open to participants now.

This study's planned enrollment of 40 is below the median of 144 across 406 interventional studies indexed under Essential Hypertension.

Browse Essential Hypertension studies →

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,900 studies on the registry; 274 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Compared within Essential Hypertension, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Hypertension. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Patients scheduled for 24-hour ambulatory blood pressure monitoring for diagnostic purposes among those suspected of having hypertension
  2. Confirmed hypertensive patients scheduled for 24-hour ambulatory blood pressure monitoring for treatment purposes

    • Either criterion 1 or 2 are planned to be selected as study participants.

Exclusion criteria

Exclusion Criteria:

  • Participants who do not consent to the study
  • Individuals with a of 30 or above (there's a concern of measurement errors as the standard 24-hour ambulatory blood pressure cuffs may not fit well)
  • Pregnancy
  • Baseline heart disease patients: individuals with a history of hospitalization due to heart failure, valvular disease, or myocardial infarction
  • Patients diagnosed with atrial fibrillation on a 12 lead within the past 6 months
  • End-stage renal disease (patients undergoing dialysis)
  • Users of mobile phones that are not compatible with the test device (CART-I plus) used in the study
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Ring arm

    Device: CART-I Plus

Interventions

  • DeviceCART-I Plus

    Photoplethysmography based ring-type blood pressure measurement device

06

What researchers measure

Primary outcomes

  1. The average agreement between blood pressure measured with a 24-hour ambulatory BP measurement device and blood pressure measured with a ring-type BP measurement device during a subject's activity time.

    Time frame: Compare the blood pressure measured over 24 hours using a ring-type blood pressure monitor and 24-hour ambulatory blood pressure monitoring.

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 16, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06084065
Responsible party
Hae-young Lee (Head of Cardiology, Seoul National University Hospital) — Principal investigator
First posted
Oct 16, 2023
Start date
Jul 13, 2023
Primary completion
Dec 31, 2023 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Oct 16, 2023

Study contacts

Hae-Young Lee, Professor
Contact
hylee612@snu.ac.kr
+82-02-2072-0698
Huijin Lee, Clinical Fellow
Contact
gmlwls0227@gmail.com

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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