Clinical trials: Hematuria
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
Urothelial Carcinoma
Performance Evaluation of a Urine-based Methylation Assay for Urothelial Carcinoma
Urothelial carcinoma (UC) is the most common malignancy of the urinary system. Hematuria is a significant clinical manifestation of UC, often diagnosed through invasive procedures.
- Trial name
- UMT-UC (NCT06912672)
- Testing
- Evaluate the diagnostic performance of EPIPROBE TAGMe DNA Methylation Detection Kit for Urothelial Cancer
- Volunteers
- 1,500 people
- Sponsor
- Shanghai Epiprobe Biotechnology Co., Ltd.
Bladder Cancer, Hematuria
Multi Institutional Study in Patient Presenting With Hematuria
The primary objective of this study is to evaluate the performance of the methylation marker panel for the detection of bladder cancer in patients with gross or microscopic hematuria.
- Trial name
- NCT03122964
- Testing
- AssureMDx
- Where
- United States
- Volunteers
- 1,148 people, healthy volunteers welcome
- Sponsor
- MDx Health
Hematuria, Dysuria
Efficacy Study of a Urine DEK ELISA for Diagnosis of Bladder Cancer
The objective of this study is to use a DEK ELISA to quantitatively measure DEK protein in the urine of patients suspected of having bladder cancer.
- Conditions
- Hematuria, Dysuria, Bladder Cancer
- Trial name
- NCT01563796
- Where
- United States
- Volunteers
- 1,115 people
- Sponsor
- Medical Diagnostic Laboratories, LLC
Upper Tract Urinary Carcinoma
Detection of Disease in the Upper Tract
An observational study of Cxbladder performance for detection or rule-out of upper tract urothelial cancer. Subjects will be prospectively recruited to a single arm observational study to validate the performance characteristics…
- Trial name
- DEDUCT (NCT05349812)
- Sponsor
- Pacific Edge Limited
Urinary Tract Infections, Proteinuria
Scanadu Urine Device Validation Study Protocol
This study will test Scanadu Urine Device for clinical performance and usability.
- Conditions
- Urinary Tract Infections, Proteinuria, Ketone Urine, Hematuria
- Trial name
- NCT02973178
- Testing
- Scanadu Urine Device
- Where
- 2 sites in United States
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Scanadu, Inc.
Nephritis, Hereditary, Hematuria-Nephropathy-Deafness Syndrome
Biomarker for Alport Syndrome (BioAlport)
International, multicenter, observational, longitudinal monitoring study to identify biomarker/s for Alport syndrome and to explore the clinical robustness, specificity, and long-term variability of these biomarker/s
- Trial name
- BioAlport (NCT02718027)
- Where
- 7 sites in Albania, Georgia and 5 more
- Volunteers
- 12 people
- Sponsor
- CENTOGENE GmbH Rostock
Hematuria
Comparison of Microtrauma in Urethra After Usage of Different Catheters
The study is undertaken to investigate if the urethral microtrauma, caused by intermittent catheterization, differs between three hydrophilic catheters for intermittent catheterization, LoFric; SpeediCath (SC) and SpeediCath…
- Trial name
- NCT01600443
- Testing
- LoFric, SpeediCath, SpeediCath Compact Male
- Where
- Sweden
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Wellspect HealthCare
Hematuria, Urothelial Carcinoma
Efficacy and Utility of Cxbladder Tests in Hematuria Patients
Prospective observational study to validate the performance characteristics and clinical utility of Cxbladder tests in a Veterans Affairs cohort.
- Trial name
- DRIVE (NCT04943380)
- Testing
- Cxbladder
- Where
- 10 sites in United States
- Volunteers
- 682 people
- Sponsor
- Pacific Edge Limited
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.
Bladder Cancer
Clinical Evaluation of the miR Sentinel BCa™ Test to Diagnose Bladder Cancer in Hematuria Patients
The purpose of the study is to establish the clinical performance and utility of the miR Sentinel™ BCa Test, a urine exosome-based diagnostic test, as an aid in diagnosing bladder cancer.
- Trial name
- NCT04155359
- Where
- United States
- Volunteers
- 444 people
- Sponsor
- miR Scientific LLC
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
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
Renal Insufficiency, Chronic, Heart Failure
Clinical Validation Through Analytical Study With Urine Samples to Compare the Effectiveness and Security of an Intelligent 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…
- Conditions
- Renal Insufficiency, Chronic, Heart Failure, Diabete Mellitus, Diabetes; Nephropathy (Manifestation)
- Trial name
- STSD-2019-001 (NCT03965975)
- Testing
- Lab Gold Standard, S-There
- Where
- Spain
- Volunteers
- 700 people, healthy volunteers welcome
- Sponsor
- S-There Technologies SL
Proteinuria
Safety and Pharmacokinetic Study of Subcutaneous ALXN1720 in Participants With Proteinuria
The primary objective of this study is to assess the impact of proteinuria on the pharmacokinetic (PK) of a single dose of ALXN1720 in participants with proteinuria.
- Trial name
- NCT05314231
- Testing
- ALXN1720
- Where
- 2 sites in South Korea
- Volunteers
- 13 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Microscopic or Gross Hematuria
Hematuria Evaluation Trial for Subjects With Microscopic or Gross Hematuria to Determine the Absence or Presence of Bladder Cancer
The purpose of the study is to evaluate subjects with gross or microscopic hematuria undergoing scheduled cystoscopy to determine the absence or presence of bladder cancer.
- Trial name
- NCT00975455
- Where
- 13 sites in United States
- Volunteers
- 1,400 people, healthy volunteers welcome
- Sponsor
- Predictive Biosciences
Hematuria, Urothelial Carcinoma
STRATA: Safe Testing of Risk for AsymptomaTic MicrohematuriA
To evaluate the clinical utility associated with the integration of Cxbladder into the evaluation of subjects presenting with hematuria for evaluation of urothelial carcinoma (UC) without compromising detection of UC.
- Trial name
- NCT03988309
- Testing
- Cxbladder
- Where
- 12 sites in United States, Canada
- Volunteers
- 554 people
- Sponsor
- Pacific Edge Limited
Healthy
Evaluation of Residual Urine After Intermittent Catheterisation
Intermittent catheterization is a well-known method used for emptying the bladder. The objective of this study is to compare the residual urine after intermittent catheterisation with 2 different, hydrophilic coated, intermittent…
- Trial name
- NCT00324233
- Testing
- Intermittent catheter, Compact intermittent catheter
- Where
- Denmark
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Coloplast A/S