Clinical Validation of The Combei BP 880 W

NCT05883605 | Completed

• 1 other identifier: VALCOMBW22
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

Clinical validation of the wrist blood pressure measuring device Combei BP 880 W for home use according to "the Universal Standard for the validation of blood pressure measuring devices by the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO)" in the general population.

Conditions

Hypertension

Keywords

validation; Blood pressure.; wrist device; electronic BP device; home Blood pressure

Outcome Measures

Primary Outcomes (1)

• Accuracy of blood pressure measurement

  differences \< than 5 +/- 8 mmHg according to the protocol by comparison to the gold standard (mercury sphygmomanometer)

  Subject will participate to only one session of measurement. The duration of one session is about 45 minutes.

Secondary Outcomes (1)

• differences between the tested device and the gold standard (mercury sphygmomanometer according to the baseline blood pressure and to the wrist circumference

  Subject will participate only one time to the study. one session of blood pressure measurement will be performed. the duration of one session is about 45 minutes

Study Arms (1)

one population of normotensive and hypertensive

OTHER

treated and untreated normotensive and hypertensive patients

Device: Measuring blood pressure

Interventions

Measuring blood pressure DEVICE

Measuring blood pressure using electronic device and using a mercury sphygmomanometer

one population of normotensive and hypertensive

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: Minimunn 30% male or female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient older than 12 years;
• Patient who signed the informed consent form;
• Patient followed-up at site (in-patient or out-patient);
• Patient with wrist circumference between 12.5 and 21.5 cm\*. \*in accordance with the Indications For Use of the Combei BP 880 W device.

You may not qualify if:

• Patient unable to give a consent or understand properly protocol information;
• Patient suffering from arrhythmia;
• Patient with poor quality of Korotkov sounds;
• Patient for whom K5 sounds are absent.

Sponsors & Collaborators

• International Society for Vascular Health: lead

Study Sites (1)

Roland Asmar

Paris, 75016, France

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• ROLAND ASMAR

  International Society of Vascular Health

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Roland Asmar

Study Record Dates

• First Submitted: May 31, 2022
• First Posted: June 1, 2023
• Study Start: January 10, 2023
• Primary Completion: May 23, 2023
• Study Completion: May 27, 2023
• Last Updated: June 1, 2023

Record last verified: 2023-05

Locations

FR (1)