Clinical Trials Logo
  1. Home
  2. Healthy
  3. NCT04676152
  4. Details
NCT04676152 Clinical Trial

Validation of Noninvasive Blood Pressure Device

Healthy Clinical Trial

Official title:
Validation of Noninvasive Blood Pressure Device

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04676152
Other study ID # TORR0004
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 5, 2020
Est. completion date November 2, 2020

Study information
Verified date January 2024
Source Masimo Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a prospective, nonrandomized multi-center study for the investigation of noninvasive sphygmomanometers. The purpose of the study is to validate the clinical performance of the Masimo noninvasive blood pressure device compared to reference auscultatory measurements.

Recruitment information / eligibility
Status Completed
Enrollment 106
Est. completion date November 2, 2020
Est. primary completion date November 2, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Age 18 years and older - Site 1; Stage 1 only: Subjects with a history of hypertension (> 140/85 mmHg) or hypotension (< 100/60 mmHg) within the last 3 months. Stage 2 only: No criterion for blood pressure - Site 2; Stage 1 and 2: Subjects with systolic blood pressure < 140/90 mmHg. - Ability to provide informed consent Exclusion Criteria: - Febrile subjects - Subjects displaying respiratory symptoms, or with suspected respiratory illness - Subjects whose skin is not intact, e.g. wounded, in or at the vicinity of the cuff placement site - Subjects with removed axillary lymph nodes or mastectomies - Subjects with peripheral artery disease - Pregnant women (patient reported) - Subjects deemed not suitable for the study at the discretion of the investigator

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Masimo Noninvasive Blood Pressure Device
Non-invasive blood pressure device

Locations
Country Name City State
United States Site 2 Irvine California
United States Site 1 Lomita California

Sponsors (1)
Lead Sponsor Collaborator
Masimo Corporation

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Mean and Standard Deviation of Differences Between Masimo NIBP Device and Manual Sphygmomanometer Measurements. Performance will be determined by calculating the mean and standard deviation of the differences between the systolic and diastolic blood pressure measurements obtained from Masimo NIBP device and manual sphygmomanometer. 1 hour
See also
  Status Clinical Trial Phase
Recruiting NCT06052553 - A Study of TopSpin360 Training Device N/A
Completed NCT05511077 - Biomarkers of Oat Product Intake: The BiOAT Marker Study N/A
Recruiting NCT04632485 - Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
Completed NCT05931237 - Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults N/A
Terminated NCT04556032 - Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women N/A
Completed NCT04527718 - Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers Phase 1
Completed NCT04065295 - A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225 Phase 1
Completed NCT04998695 - Health Effects of Consuming Olive Pomace Oil N/A
Completed NCT04107441 - AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects Phase 1
Completed NCT01442831 - Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects Phase 1
Terminated NCT05934942 - A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood Phase 1
Recruiting NCT05525845 - Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI N/A
Completed NCT05515328 - A Study in Healthy Men to Test How BI 685509 is Processed in the Body Phase 1
Completed NCT04967157 - Cognitive Effects of Citicoline on Attention in Healthy Men and Women N/A
Completed NCT05030857 - Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects Phase 1
Recruiting NCT04494269 - A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls Phase 1
Recruiting NCT04714294 - Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers Phase 1
Completed NCT04539756 - Writing Activities and Emotions N/A
Recruiting NCT04098510 - Concentration of MitoQ in Human Skeletal Muscle N/A
Completed NCT03308110 - Bioavailability and Food Effect Study of Two Formulations of PF-06650833 Phase 1