NCT06457568

Brief Summary

The purpose of this study is to assess the accuracy of the CONTEC08C automated oscillometric upper-arm sphygmomanometer in the general population for clinical use according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension /International Organization for Standardization (AAMI/ESH/ISO) Universal Standard (ISO 81060-2:2018).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 25, 2024

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

June 8, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 13, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 25, 2024

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2024

Completed
Last Updated

June 24, 2024

Status Verified

June 1, 2024

Enrollment Period

2 months

First QC Date

June 8, 2024

Last Update Submit

June 20, 2024

Conditions

Blood Pressure

Outcome Measures

Primary Outcomes (1)

  • Blood pressure measurement data

    Systolic Blood Pressure and Diastolic Blood Pressure

    30mintues

Study Arms (1)

CONTEC08C and mercury sphygmomanometer

EXPERIMENTAL

Blood Pressure Measurement with the CONTEC08C Oscillometric Sphygmomanometer (CONTEC08C) and with Mercury Sphygmomanometer

Diagnostic Test: Blood pressure measurement

Interventions

Blood pressure measurementDIAGNOSTIC_TEST

The blood pressure measurement was taken simultaneously by two observers using mercury sphygmomanometer and by a supervisor using the tested device, CONTEC08C.

CONTEC08C and mercury sphygmomanometer

Eligibility Criteria

Age12 Years - 79 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects aged 12 to 79 years
  • Subjects voluntarily participate in the clinical trial and sign the informed consent.

You may not qualify if:

  • Subjects with cardiac arrhythmias;
  • Pregnancy;
  • Poor quality Korotkoff sounds;
  • Subject with an arm injury incompatible with the use of a cuff-based sphygmomanometer;
  • Other conditions that the investigator considers ineligible for clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese Academy of Medical Sciences，Fuwai Hospital

Beijing, Beijing Municipality, 100037, China

RECRUITING

MeSH Terms

Interventions

Blood Pressure Determination

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisPhysical Examination

Study Officials

  • Ying Lou, MD

    Chinese Academy of Medical Sciences, Fuwai Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ying Lou, MD

CONTACT

86(10)88392170fuwailou1798@sina.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 8, 2024

First Posted

June 13, 2024

Study Start

May 25, 2024

Primary Completion

July 25, 2024

Study Completion

August 1, 2024

Last Updated

June 24, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)