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Completed Not applicable Interventional Accepts healthy volunteers

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

ClinicalTrials.gov ID: NCT03588559

Public ClinicalTrials.gov record NCT03588559. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 8, 2026, 1:35 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Assess the Accuracy of Transtek TMB-1591-A-002 Blood Pressure Monitor in Conformance With the ANSI/AAMI ISO 81060-2 Standard

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT03588559
Recruitment status
Completed
Study type
Interventional
Phase
Not applicable
Lead sponsor
BTS International
Other
Enrollment
88 participants

Conditions and interventions

Conditions

Interventions

Diagnostic Test

Eligibility (public fields only)

Age range
3 Years and older
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
May 29, 2017
Primary completion
Jun 15, 2017
Completion
Apr 22, 2018
Last update posted
Jul 16, 2018

2017 – 2018

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Clinimark, LLC Louisville Colorado 80027

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03588559, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jul 16, 2018 · Synced Sep 8, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT03588559 live on ClinicalTrials.gov.

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