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A clinical trial to compare the results of blood bioindicators using a non-invasive medical device with those from the routine laboratory tests

A comparative clinical trial for the viability of a medical device

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-3k58mg
Enrollment
Unknown
Registered
2020-05-26
Start date
2020-07-21
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Determination of blood bioindicators in healthy subjects

Interventions

The trial population will consist of 500 healthy subjects, of both sexes, aged between 18 and 55 years. The subjects will be instructed to come to the research center in the morning, being 8 to 12 hou

Sponsors

Nanotimize Tecnologia S.A
Lead Sponsor
CAEP - Centro Avançado de Estudos e Pesquisas
Collaborator

Eligibility

Age
18 Years to 55 Years

Inclusion criteria

Inclusion criteria: Men or women aged between 18 and 55 years-old; being able to sign the ICF approved by IRB and to execute and understand all study procedures and instructions

Exclusion criteria

Exclusion criteria: Subjects who do not agree to participate in the clinical trial and do not sign the ICF

Design outcomes

Primary

MeasureTime frame
Evaluation of the accuracy of the medical device Progenos by comparing the results obtained by it against the results of laboratory tests—

Secondary

MeasureTime frame
Secondary endpoints are not expected—

Countries

Brazil

Contacts

Public ContactJosé Martins

Nanotimize Tecnologia S.A

jose.martins@nanotimize.com.br+55-19-98941-6717

Outcome results

None listed

Source: REBEC (via WHO ICTRP)