8 completed, 2 unknown. 10 Not applicable.
| Phase | Trials | Status |
|---|---|---|
| Not applicable | 10 | Completed 8, Unknown 2 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Evaluation of the Accuracy and Usability of the Minuteful - Kidney Urine Analysis Test System in the Lay User Hands Minuteful - Kidney Urine Analysis Test System - Albuminuria, Chronic Kidney Diseases | Not applicable | Completed | Healthy.io Ltd. | 216 | 2021-12-09 | 2023-05-03 |
| Evaluation of the Accuracy and Usability of the ACR | U.S. Urine Analysis Test System in the Lay User Hands ACR | U.S. Urine Analysis Test System, URiSCAN Optima Urine Analyzer - Albuminuria | Not applicable | Completed | Healthy.io Ltd. | 250 | 2020-08-31 | 2023-05-09 |
| A Comparative, Controlled Study to Evaluate the Clinical Accuracy of the Velieve U.S. UTI Urine Analysis Test System Velieve U.S. - Urinary Tract Infections | Not applicable | Completed | Healthy.io Ltd. | 125 | 2020-02-05 | 2020-06-23 |
| Towards HOMe-based Albuminuria Screening: an Implementation Study Testing Two Approaches Approach A (PeeSpot urine collection device)., Approach B (ACR | EU Test kit). - Albuminuria | Not applicable | Unknown | University Medical Center Groningen | 15032 | 2019-11-14 | 2022-04-05 |
| ACR | LAB Urine Analysis Test System Evaluation of Performance ACR LAB - Diabetes, Hypertension | Not applicable | Completed | Healthy.io Ltd. | 375 | 2019-06-30 | 2020-07-10 |
| Dip Home-Based Dipstick Analyzer Performance Evaluation Experimental: Dip Home-Based Dipstick Analyzer - Urine Detectable Acute and Chronic Diseases | Not applicable | Completed | Healthy.io Ltd. | 250 | 2018-04-05 | 2020-07-10 |
| Improving Albuminuria Screening Compliance Using a Smartphone Urinalysis Kit Mailed Urinalysis Smartphone Kit - Albuminuria, Chronic Kidney Diseases | Not applicable | Completed | Geisinger Clinic | 999 | 2018-03-19 | 2018-07-24 |
| Study Assessing the Usability and Patient Satisfaction With Digital Urinalysis in the Context of Routine Pre-natal Care. Dip HBDA - Pregnancy | Not applicable | Unknown | Healthy.io Ltd. | 300 | 2017-05-07 | 2017-08-22 |
| A Comparative, Controlled Study to Evaluate the Lay User Accuracy and Performance of the Dip Home-Based Dipstick Analyzer Dip Home-Based Dipstick Analyzer, Urine analysis predicate device for professional user - Urine Detectable Acute and Chronic Diseases | Not applicable | Completed | Healthy.io Ltd. | 429 | 2017-03-05 | 2020-07-10 |
| Healthy.io Method Comparison & User Performance Study Dip.io Home Based Dipstick Analyzer, ACON U500 MissionĀ® U500 Urine Analyzer - Urinary Tract Infection, Kidney Failure | Not applicable | Completed | Healthy.io Ltd. | 425 | 2015-10-01 | 2017-09-11 |
Albuminuria (4) · Diabetes Mellitus (4) · Hypertension (4) · Renal Insufficiency, Chronic (3) · Cardiovascular Diseases (2) · Chronic Disease (2) · Urinary Tract Infections (2) · Alzheimer Disease (1) · Hypercholesterolemia (1) · Renal Insufficiency (1)
United States (9) · Netherlands (1)
Alex R Chang, MD (1) · Anne Burke, MD (1) · Ron T Gansevoort, MD, PhD (1)