NCT03588559

Brief Summary

The clinical protocol of the trial:

  1. 1.Objective of the trial: To assess the accuracy of device.
  2. 2.Test methods and procedures: Perform comparation test on seated position by two devices at the same time.
  3. 3.DUT: Transtek Blood Pressure Monitor, Model TMB-1591-A-002, with Cuff (sizes, cm) 15-21, 20-26, 25-34, 25-34(L), 32-43, 32-43(L), 40-55.
  4. 4.Reference device: Baumanometer Desk Mercury Sphygmomanometer.
  5. 5.Study endpoints: Comply with ANSI/AAMI ISO 81060-2:2013 standard.
  6. 6.Statistical methodology used: Standard deviation, Mean error.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2017

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

May 30, 2017

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 16, 2017

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 23, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 24, 2018

Completed
23 days until next milestone

First Posted

Study publicly available on registry

July 17, 2018

Completed
Last Updated

July 17, 2018

Status Verified

July 1, 2018

Enrollment Period

17 days

First QC Date

June 24, 2018

Last Update Submit

July 4, 2018

Conditions

Blood Pressure

Keywords

Monitors, Blood Pressure

Outcome Measures

Primary Outcomes (1)

  • Blood pressure measurement data

    Systolic Pressure and Diastolic Pressure

    30 minutes

Study Arms (1)

BPM, TMB-1591-A-002 and Reference Device

EXPERIMENTAL

DUT: Transtek Blood Pressure Monitor TMB-1591-A-002 Reference Device: Baumanometer Desk Mercury Sphygmomanometer. Blood Pressure Measurement with the Transtek BPM TMB-1591-A-002 and with reference device.

Diagnostic Test: Blood Pressure Measurement

Interventions

Blood Pressure MeasurementDIAGNOSTIC_TEST

Measurement blood pressure by Transtek BPM TMB-1591-A-002 and reference device.

Also known as: Transtek TMB-1591-A-002 and reference device, blood pressure
BPM, TMB-1591-A-002 and Reference Device

Eligibility Criteria

Age3 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinimark, LLC

Louisville, Colorado, 80027, United States

Location

MeSH Terms

Interventions

Blood Pressure DeterminationBlood Pressure

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisPhysical ExaminationVital SignsHemodynamicsCardiovascular Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Study Officials

  • Nagulinie Shukla

    Clinimark, LLC

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2018

First Posted

July 17, 2018

Study Start

May 30, 2017

Primary Completion

June 16, 2017

Study Completion

April 23, 2018

Last Updated

July 17, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)