Clinical Validation Through Analytical Study With Urine Samples to Compare the Effectiveness and Security of an Intelligent Device (STSD-2019-001)

S-There Technologies

Status: Unknown

Conditions: Diabetes; Nephropathy (Manifestation); Urinary Tract Infections; Hematuria; Diabete Mellitus; Heart Failure; Renal Insufficiency, Chronic

Treatments: Device: S-There; Device: Lab Gold Standard

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03965975

S-There Smart Device-2019-001

Details and patient eligibility

About

The objectives of the Clinical Validation Through Analytical Study With Urine Samples to Compare the Effectiveness and Security of an Intelligent Device are:

1.To evaluate the performance of S-There Device in comparison to the golden standard used in the lab.

Enrollment: 700 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients who came to the emergency room, primary care and nephrology unit.

Exclusion criteria

• Subject cannot collect urine in receptacle.
• Urinary Catheter

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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700 participants in 1 patient group

All participants (single arm)

Other group

Description:

All study participants once enrolled into the study were asked to collect their midstream urine in the designated urine cups. The urine sample was then sent the Lab and tested sequentially; first by the golden standard techniques used by the Lab (first intervention) and by the S-There device (comparative device - second intervention).

Treatment:

Device: S-There

Device: Lab Gold Standard