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

• Sponsor: S-There Technologies SL (Industry)
• Overall Status: Unknown status
• CT.gov ID: NCT03965975
• Collaborator: Biocruces Bizkaia Health Research Institute (Other), Hospital de Cruces (Other)
• Enrollment: 700
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 8.7
• Patients Per Site Per Month: 80.4

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Renal Insufficiency, Chronic; Heart Failure; Diabete Mellitus; Diabetes; Nephropathy (Manifestation); Hematuria; Urinary Tract Infections	Device: Lab Gold Standard; Device: S-There	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 700 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: (In Spanish, Spain) "Validación Clínica Mediante Estudio analítico Con Muestras de Orina Para Comparar la Eficacia y Seguridad de un Smart Device"
• Actual Study Start Date: Jun 10, 2019
• Anticipated Primary Completion Date: Mar 1, 2020
• Anticipated Study Completion Date: Mar 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Other: All participants (single arm) 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).	Device: Lab Gold Standard; First intervention (assigned to the "All participants" arm).; Device: S-There; Second intervention (assigned to the "All participants" arm).

Outcome Measures

Primary Outcome Measures

1. Accuracy to compared device [Through study completion, an average of 1 month]

   The primary objective of the study is to evaluate the accuracy of the S-There device compared to the Lab gold standards, for each analyte.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

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

Exclusion Criteria:

• Subject cannot collect urine in receptacle.

• Urinary Catheter

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital de Cruces	Barakaldo	Bizkaia	Spain	48903

Sponsors and Collaborators

• S-There Technologies SL
• Biocruces Bizkaia Health Research Institute
• Hospital de Cruces

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: S-There Technologies SL
• ClinicalTrials.gov Identifier: NCT03965975
• Other Study ID Numbers: S-There Smart Device-2019-001
• First Posted: May 29, 2019
• Last Update Posted: Dec 5, 2019
• Last Verified: Dec 1, 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Urinary Tract Infections; Renal Insufficiency; Renal Insufficiency, Chronic; Hematuria; Diabetic Nephropathies; Diabetes Mellitus

Study Results

No Results Posted as of Dec 5, 2019