Renal Insufficiency, ChronicSTSD-2019-001NCT03965975
Clinical Validation Through Analytical Study With Urine Samples to Compare the Effectiveness and Security of an Intelligent Device
A study testing Lab Gold Standard and S-There in people with Renal Insufficiency, Chronic and Heart Failure, run by S-There Technologies SL at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Renal Insufficiency, Chronic, Heart Failure, Diabete Mellitus
- What is being tested?
- Lab Gold Standard and S-There
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 700 participants
- Where
- 1 siteSpain
- Study dates
- 10 Jun 2019to Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients who came to the emergency room, primary care and nephrology unit.
Who cannot join
- Subject cannot collect urine in receptacle.
- Urinary Catheter
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital de Cruces
Barakaldo, Bizkaia, 48903
Nefrología Servicio, Unit, 946006000, eider@s-there.com
About this study
Official title: (In Spanish, Spain) "Validación Clínica Mediante Estudio analítico Con Muestras de Orina Para Comparar la Eficacia y Seguridad de un Smart Device"
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.
- Conditions
- Renal Insufficiency, Chronic, Heart Failure, Diabete Mellitus, Diabetes; Nephropathy (Manifestation), Hematuria, Urinary Tract Infections
- Being tested
- Lab Gold Standard, S-There
- Medical subject headings
- Renal Insufficiency, Chronic, Heart Failure, Diabetes Mellitus, Kidney Diseases, Hematuria, Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lab Gold StandardDevice
First intervention (assigned to the "All participants" arm).
S-ThereDevice
Second intervention (assigned to the "All participants" arm).
| Study group | Role | What they receive |
|---|---|---|
| All participants (single arm) | Other | 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). Receives: Device: Lab Gold Standard; Device: S-There |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy to compared device
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.
Measured: Through study completion, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2019
- Study start10 Jun 2019
- Primary completionMar 2020 (estimated)
- Study completionMar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Insufficiency, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- S-There Technologies SL
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biobizkaia Health Research Institute, Hospital de Cruces
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03965975
- Sponsor's protocol ID
- S-There Smart Device-2019-001
- Acronym
- STSD-2019-001
- Status last verified
- Dec 2019
- First submitted
- 24 May 2019
- Last updated
- 5 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- (In Spanish, Spain) "Validación Clínica Mediante Estudio analítico Con Muestras de Orina Para Comparar la Eficacia y Seguridad de un Smart Device"
- ClinicalTrials.gov ID
- NCT03965975
- Acronym / sponsor ID
- STSD-2019-001 / S-There Smart Device-2019-001
- Conditions
- Renal Insufficiency, Chronic, Heart Failure, Diabete Mellitus, Diabetes; Nephropathy (Manifestation), Hematuria, Urinary Tract Infections
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- S-There Technologies SLIndustry (pharma, biotech, devices)
- Collaborators
- Biobizkaia Health Research Institute, Hospital de Cruces
- Study start
- 10 Jun 2019 (actual)
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Mar 2020 (estimated)
- First posted
- 29 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All participants (single arm) | Other | Device: Lab Gold Standard, Device: S-ThereAll 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who came to the emergency room, primary care and nephrology unit.
Key exclusion criteria (2 listed)
- Subject cannot collect urine in receptacle.
- Urinary Catheter
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lab Gold StandardFirst intervention (assigned to the "All participants" arm). | Device | All participants (single arm) |
| S-ThereSecond intervention (assigned to the "All participants" arm). | Device | All participants (single arm) |
Primary outcome
Accuracy to compared device
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lab Gold Standard and S-There in people with Renal Insufficiency, Chronic and Heart Failure, run by S-There Technologies SL at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy to compared device (time frame: Through study completion, an average of 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2019.