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Clinical Trial of Blood Pressure Monitor in Conformance With the ANSI/AAMI ISO 81060-2 Standard

NCT03588559 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2018-07-17

No results posted yet for this study

Summary

The clinical protocol of the trial:

1. Objective of the trial: To assess the accuracy of device.
2. Test methods and procedures: Perform comparation test on seated position by two devices at the same time.
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. Reference device: Baumanometer Desk Mercury Sphygmomanometer.
5. Study endpoints: Comply with ANSI/AAMI ISO 81060-2:2013 standard.
6. Statistical methodology used: Standard deviation, Mean error.

Conditions

  • Blood Pressure

Interventions

DIAGNOSTIC_TEST

Blood Pressure Measurement

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

Sponsors & Collaborators

  • Clinimark, LLC

    collaborator OTHER

  • Guangdong Transtek Medical Electronics Co., Ltd.

    collaborator INDUSTRY

  • BTS International

    lead OTHER

Principal Investigators

  • Nagulinie Shukla · Clinimark, LLC

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-05-30
Primary Completion
2017-06-16
Completion
2018-04-23
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03588559 on ClinicalTrials.gov