NCT07024472

Brief Summary

The purpose of the study is to compare NIBP cuff materials and their effect on the measurement results.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2025

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

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

First Submitted

Initial submission to the registry

March 31, 2025

Completed
25 days until next milestone

Study Start

First participant enrolled

April 25, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 17, 2025

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 23, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 23, 2025

Completed
Last Updated

July 3, 2025

Status Verified

March 1, 2025

Enrollment Period

2 months

First QC Date

March 31, 2025

Last Update Submit

July 1, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Primary Outcome Measure

    The primary outcome is to collect NIBP measurement data from subjects in laboratory setting to show equivalency of the different NIBP Cuff.

    From admission to discharge

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy volunteers

You may qualify if:

  • Age \>= 18 years to 65 years
  • Are able and willing to comply with the study procedures.
  • Are able and willing to provide written informed consent to participate.
  • A cuff of same size is applicable to both arms (difference between the limbs should be less than 2cm)
  • Blood pressure needs to be measurable from both arms.

You may not qualify if:

  • Are pregnant.
  • Are breastfeeding.
  • Have participated in the study. No subject may participate more than once.
  • Have an AV fistula.
  • Have acute infection.
  • Have subject reported arrythmias.
  • PI or designee decision due to subject health conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Metropolia University of Applied Sciencies

Helsinki, 00920, Finland

Location

Metropolia University of Applied Sciencies

Helsinki, Finland

Location

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2025

First Posted

June 17, 2025

Study Start

April 25, 2025

Primary Completion

June 23, 2025

Study Completion

June 23, 2025

Last Updated

July 3, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations