Clinical trials: Urinalysis
Hematuria, Cystoscopy
Bladder EpiCheck European Haematuria Study
The goal of this observational study is to further validate the sensitivity and specificity of Bladder EpiCheck in primary detection of urothelial carcinoma in participants aged 45 years or older presenting with haematuria…
- Conditions
- Hematuria, Cystoscopy, Urothelial Carcinoma Bladder, Urothelial Carcinoma of the Renal Pelvis and Ureter
- Trial name
- NCT06818136
- Testing
- Bladder EpiCheck
- Where
- 5 sites in United Kingdom
- Volunteers
- 800 people
- Sponsor
- Nucleix Ltd.
Urothelial Carcinoma
The Cxbladder Monitoring Study
The aim of this trial is to determine the performance characteristics of the Cxbladder test for the detection of recurrent urothelial carcinoma (UC) in patients with a recent history of urinary tract UC, who have been treated…
- Trial name
- NCT02700659
- Testing
- Cxbladder
- Where
- 11 sites in United States
- Volunteers
- 803 people
- Sponsor
- Pacific Edge Limited
Urothelial Carcinoma
Detection and Risk Stratification in Veterans Presenting With Microscopic Hematuria
It is currently debated whether the use of invasive standard of care procedures, such as cystoscopy, a procedure which involves inserting a thin camera, called a cystoscope, into the bladder to look for signs of disease, is…
- Trial name
- microDRIVE (NCT05889195)
- Testing
- Cxbladder urine test
- Where
- 3 sites in United States
- Volunteers
- 1,000 people
- Sponsor
- Pacific Edge Limited
Kidney Transplant Failure and Rejection
Assessment of QSant™ for Underlying Allograft Rejection
The AQUA registry is a multi-center observational study to assess the clinical management of kidney transplant recipients (KTRs) with use of the QSant test.
- Trial name
- AQUA (NCT05282966)
- Testing
- QSant-TM Urine Test
- Volunteers
- 4,000 people
- Sponsor
- NephroSant
Pregnancy
Study Assessing the Usability and Patient Satisfaction With Digital Urinalysis in the Context of Routine Pre-natal Care.
The study is a home-based, usability study assessing the use of the Dip Home-Based Dipstick Analyzer (HBDA) in the context of prenatal care.
- Trial name
- NCT03134274
- Testing
- Dip HBDA
- Where
- United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Healthy.io Ltd.
Urinary Tract Infections
A Comparative, Controlled Study to Evaluate the Clinical Accuracy of the Velieve U.S. UTI Urine Analysis Test System
The Velieve U.S. UTI Urine Analysis Test System (henceforth Velieve U.S.) is composed of a kit and a smartphone application. The device will be provided to the subject in a simulated home-use environment.
- Trial name
- NCT04371159
- Testing
- Velieve U.S.
- Where
- United States
- Volunteers
- 125 people, healthy volunteers welcome
- Sponsor
- Healthy.io Ltd.
Albuminuria
Evaluation of the Accuracy and Usability of the ACR | U.S. Urine Analysis Test System in the Lay User Hands
Eligible subjects meeting the pathological profile will be recruited at the designated site by the study personnel. Following subject consent, the subjects will be evaluated for eligibility based on their health condition and…
- Trial name
- NCT04626271
- Testing
- ACR | U.S. Urine Analysis Test System, URiSCAN Optima Urine Analyzer
- Where
- 2 sites in United States
- Volunteers
- 250 people, healthy volunteers welcome
- Sponsor
- Healthy.io Ltd.
Asymptomatic Bacteriuria, Asymptomatic Pyuria
Urinalysis Results in Healthy Individuals
This is a prospective, observational study assessing the results of urine dipsticks on adult volunteers with no acute symptoms. We seek to determine the frequency of leukocytes or nitrites in this group of individuals.
- Trial name
- NCT04055675
- Testing
- Urine dipstick test
- Where
- United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Kendall Healthcare Group, Ltd.
Healthy
Heavy Metal Urine Analysis in 20 Healthy Persons Taking Mineralox
Researchers want to find out if urine heavy metal levels are changed in persons who use Mineralox Basic C™ (Mineralox). Mineralox is a zeolite (clinoptilolite) in combination with Vitamin C.
- Trial name
- NCT00623675
- Testing
- Mineralox C
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- CreoMed, Inc.
Bladder Cancer, Urothelial Carcinoma Bladder
Evaluating Bladder CARE™, a New Non-Invasive Urine Test, for Bladder Cancer Detection in Inconclusive Cases
The goal of this observational study is to learn about the performance of the Bladder CARE™ Assay in patients suspected of having bladder cancer with atypical cytology or equivocal cystoscopy results.
- Trial name
- NCT06870253
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- Pangea Laboratory LLC
Diabetes, Hypertension
ACR | LAB Urine Analysis Test System Evaluation of Performance
The ACR LAB is a prescription-only, nurse- or clinician-conducted in vitro diagnostic (IVD) device. The test is for the qualitative and semi- quantitative detection of Albumin, Creatinine, and the Albumin-to- Creatinine Ratio.
- Trial name
- NCT04466501
- Testing
- ACR LAB
- Where
- 3 sites in United States
- Volunteers
- 375 people, healthy volunteers welcome
- Sponsor
- Healthy.io Ltd.
COPD Exacerbation
COPD Exacerbation Alert System With urinE anaLysis Using the HEADSTART Device
The Headstart Test system is an in vitro diagnostic test intended for self-testing for the detection of five biomarkers of infection in the urine of patients diagnosed with chronic obstructive pulmonary disease (COPD).
- Trial name
- COPE-WEL (NCT04296318)
- Where
- United Kingdom
- Volunteers
- 86 people
- Sponsor
- Mologic Ltd
Hematuria - Cause Not Known
Study to Assess the Impact of the Urine Test Cxbladder Triage Plus on the Number of Cystoscopies Performed on Patients With Invisible Blood in Their Urine.
This study includes adult patients who see a urologist because of blood in their urine. The amount is so small it can only be seen with a microscope. This is called microhematuria. There can be many reasons for microhematuria.
- Trial name
- CREDIBLE (NCT06394869)
- Testing
- Cxbladder Triage Plus
- Where
- 20 sites in United States
- Volunteers
- 1,000 people
- Sponsor
- Pacific Edge Limited
Urinalysis
Ketostix® and Keto-Diastix® Performance Study
Persons with Diabetes (PWDs), at minimum of (n=120) will successfully collect their urine and test with two Ascensia strip products. The products are: Ketostix and Keto-Diastix.
- Trial name
- NCT06053593
- Testing
- Testing of self collected urine, Labeling Evaluation, Urine Control testing
- Where
- United States
- Volunteers
- 126 people
- Sponsor
- Ascensia Diabetes Care
Albuminuria, Chronic Kidney Diseases
Evaluation of the Accuracy and Usability of the Minuteful - Kidney Urine Analysis Test System in the Lay User Hands
The purpose of this study was to collect additional performance and clinical data on the Minuteful - Kidney test device (previously "ACR | U.S. Urine Analysis Test System"), following the original data collection (NCT04626271).
- Conditions
- Albuminuria, Chronic Kidney Diseases, Diabetes, Hypertension
- Trial name
- NCT05838872
- Testing
- Minuteful - Kidney Urine Analysis Test System
- Where
- United States
- Volunteers
- 216 people
- Sponsor
- Healthy.io Ltd.