Clinical trials: Detection
HAV
Access Anti-HAV and Access Anti-HAV IgM Assays EU Clinical Trial Protocol (HAV-EU-11-23)
The purpose of this study is to evaluate the clinical performance supporting that intended purpose of the Access anti-HAV as an aid in the laboratory diagnosis of HAV infection and for detection of anti-HAV after vaccination and…
- Trial name
- NCT06289868
- Testing
- Access anti-HAV and Access anti-HAV IgM on the DxI 9000 Access Immunoassay Analyzer and CE-marked predicate assays, Access anti-HAV on the DxI 9000 Access Immunoassay Analyzer and CE-marked predicate assays
- Where
- 2 sites in France
- Volunteers
- 1,409 people
- Sponsor
- Beckman Coulter, Inc.
Diabetic Retinopathy
A Multi-center Study to Evaluate Performance of an Automated Device for the Detection of Diabetic Retinopathy
Diabetes affects 30.3 million people or 9.3% of the population of the United States. Results of a study by the Eye Diseases Prevalence Research Group reveal that 40% of diabetes patients have some degree of diabetic retinopathy…
- Trial name
- NCT02963441
- Testing
- LumineticsCore (formerly IDX-DR)
- Volunteers
- 900 people
- Sponsor
- Digital Diagnostics, Inc.
Parkinson Disease
Objective Quality of Life Detection Validation
The purpose of this research study is to: Collect data to use in the development of a standardized tool for identifying patients with Parkinson's disease (PD) who would benefit from advanced therapies (AT) such as deep brain…
- Trial name
- NCT04121793
- Testing
- Kinesia 360 and Smartphone sensors
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Great Lakes NeuroTechnologies Inc.
Breast Neoplasms, Breast Cancer Detection
Diagnostic Accuracy of Carebot AI MMG in Mammography Screening: Multicenter MRMC Study
This study evaluates the diagnostic performance of Carebot AI MMG, an artificial intelligence (AI)-enabled medical device for evaluating mammograms.
- Conditions
- Breast Neoplasms, Breast Cancer Detection, Breast Cancer - Female, Breast Cancer Screening
- Trial name
- CARE-MMG-MRMC (NCT07298252)
- Testing
- Carebot AI MMG software analysis
- Where
- 4 sites in Czechia, Slovakia
- Volunteers
- 222 people, healthy volunteers welcome
- Sponsor
- Carebot s.r.o.
Renal Cell Carcinoma, Kidney Cancer
Pre-surgical Detection of Clear Cell Renal Cell Carcinoma (ccRCC) Using Radiolabeled G250-Antibody
This is a multicenter Phase III study to demonstrate the diagnostic utility of 124I-cG250 PET/CT pre-surgical imaging in patients with operable renal masses.
- Trial name
- NCT00606632
- Testing
- 124-Iodine-cG250 (124I-cG250), CT
- Where
- 14 sites in United States
- Volunteers
- 226 people
- Sponsor
- Heidelberg Pharma AG
Breast Cancer Awareness
Breast Mapping and Detection of Suspicious Breast Lesions Using Feminai
Prospective observational study evaluating the safety and accuracy of Feminai 1.0, an at-home adhesive patch that measures skin temperature and electrical impedance to map each breast.
- Trial name
- NCT07220863
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- Feminai
Nephrogenic Systemic Fibrosis, Renal Insufficiency
Evaluation of Nephrogenic Systemic Fibrosis (NSF) in Patients With Chronic Kidney Disease Following OptiMARK Injection
The objective of this study is to prospectively monitor the incidence of adverse drug reactions, specifically NSF during routine use of gadoversetamide in a large number of patients with moderate renal insufficiency (eGFR 30-59)…
- Trial name
- SHERLOC (NCT00811863)
- Where
- United States
- Sponsor
- Guerbet
Right to Left Shunt, Patent Foramen Ovale
Right to Left Cardiac Shunt Detection
The purpose of this study is to evaluate the sensitivity and specificity of the Cardiox Flow Detection System (FDS) in identifying an intracardiac right-to-left shunt (RLS) compared to the results of transesophageal…
- Conditions
- Right to Left Shunt, Patent Foramen Ovale, Atrial Septal Defect
- Trial name
- PFO Detection (NCT01773252)
- Testing
- Flow Detection System
- Where
- 8 sites in United States
- Volunteers
- 141 people
- Sponsor
- Cardiox Corporation
HIV Infections
Clinical Performance of Reveal G4 Rapid HIV-1 Antibody Test
To determine the efficacy of an improved rapid diagnostic test using venous whole blood and fingerstick whole blood. The clinical performance of Reveal G4 Rapid HIV-1 Antibody Test will be determined by comparing the results with…
- Trial name
- NCT02190578
- Testing
- Reveal G4
- Where
- 4 sites in United States
- Volunteers
- 1,649 people, healthy volunteers welcome
- Sponsor
- MedMira Laboratories Inc.
Ulcerative Colitis
Endomicroscopy in Ulcerative Colitis
This is a confirmatory, multicentric, prospective, randomized, controlled, single-blind study in subjects with long standing ulcerative colitis in clinical remission with indication for surveillance colonoscopy.
- Trial name
- NCT00659867
- Testing
- PENTAX EC-3870CIFK / EC-3870CILK confocal colonoscopes
- Where
- 5 sites in Germany, Italy
- Volunteers
- 182 people
- Sponsor
- PENTAX Europe GmbH
Pancreatic Cancer, Jaundice
The LINFU® U.S. Registry in Patients With Clinical Signs and/or Symptoms of Disease
Evaluate LINFU® in patients who exhibit signs or symptoms (i.e. jaundice, abdominal pain, weight loss, nausea and vomiting etc.) suggestive of pancreatic cancer (PDAC) or have evidence of imaging studies suggestive of PDAC.
- Conditions
- Pancreatic Cancer, Jaundice, Abdominal Neoplasm
- Trial name
- NCT06276738
- Testing
- LINFU® (Low Intensity Non-Focused Ultrasound excitation of the pancreas)
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Adenocyte, LLC
Detection Accuracy, Patient Compliance
Reliability, Safety and Usability of the Transplantation Sensor System Combined With Myfortic® in Adult Kidney Transplant Patients
The main purpose of this exploratory trial is to evaluate the reliability, safety and usability of the Transplantation Sensor System when the Ingestible Event Marker (IEM) is given in combination with ECMPS 360 mg tablets in…
- Trial name
- NCT01320358
- Testing
- ECMPS-IEM
- Where
- 5 sites in Switzerland
- Volunteers
- 30 people
- Sponsor
- Novartis Pharmaceuticals
Mass Lesion
Non-Inferiority Quantitative Transmission Ultrasound Case Collection Study
Conduct a case collection study of breast imaging examinations from women with mammographically-detected breast lesions for the purpose of conducting subsequent Reader Studies.
- Trial name
- QTUS (NCT02133417)
- Testing
- Quantitative Transmission Ultrasound
- Where
- 2 sites in United States
- Volunteers
- 287 people
- Sponsor
- QT Ultrasound LLC
Collect Blood Values With Induced Hypoxia, Induced Methemoglobinemia, and Induced Hypoxia and Methemoglobinemia
Accuracy of Detection of Methemoglobin With Pulse Oximetry
The non-invasive measurement of dysfunctional hemoglobins allows physicians to monitor levels in affected individuals without requiring blood samples or laboratory testing.
- Trial name
- NCT03869840
- Testing
- Sensor to spot check blood levels
- Where
- United States
- Volunteers
- 13 people, healthy volunteers welcome
- Sponsor
- Nonin Medical, Inc
Detection of Heart Rate and Respiratory Rate
The DistaSense VITALS Study
A prospective, non-significant risk study designed to validate the performance of the DistaSense Contactless Sensor and algorithm for detecting heart rate and respiratory rate, compared to gold standard reference technology.
- Trial name
- VITALS (NCT07217327)
- Testing
- DistaSense and Polysomnography
- Where
- 2 sites in United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Life Detection Technologies
Prostate Cancer, Prostate Cancer Recurrent
F-18-PSMA-1007 Versus F-18-Fluorocholine PET in Patients With Biochemical Recurrence
This study evaluates the diagnostic performance and safety of F-18-PSMA-1007 and F-18-Fluorocholine PET/CT imaging in patients with suspected recurrence of prostate cancer after previous definitive treatment.
- Trial name
- NCT04102553
- Testing
- F-18-PSMA-1007, F-18-Fluorocholine
- Where
- 6 sites in France
- Volunteers
- 200 people
- Sponsor
- ABX advanced biochemical compounds GmbH
Barrett Esophagus
Non-Endoscopic Detection of Barrett's Esophagus Using Methylation Biomarkers on EndoSign® Cell Collection Device Samples
This study is looking at cells collected from the esophagus using a diagnostic device called the EndoSign® Cell Collection Device (a sponge on a thread).
- Trial name
- DETECT-ME (NCT06803927)
- Testing
- Barrett's Esophagus Test (LDT)
- Where
- United States
- Volunteers
- 700 people
- Sponsor
- Cyted Health Inc
Upper Gastrointestinal Bleeding
Detection of Upper Gastrointestinal (GI) Bleeding Using a Novel Bleeding Sensor Capsule -A Pilot Study
This is a multi-center, prospective, non-randomized, open-label, exploratory clinical investigation performed to evaluate safety and effectiveness of the PillSense System when used for detection of blood in the stomach of…
- Trial name
- NCT05631639
- Testing
- PillSense System
- Where
- 3 sites in Czechia
- Volunteers
- 30 people
- Sponsor
- EnteraSense Limited
Diabetic Retinopathy, Diabetes
OPTDR01 Feasibility for Automated Diabetic Retinopathy Detection
In the United States, only 62% of the 37 million people with diabetes receive annual screening exams for diabetic retinopathy. One of the goals of the US Department of Health and Human Services Healthy People 2030 campaign is to…
- Trial name
- NCT06343350
- Testing
- OPTDR01 software application
- Where
- 3 sites in United States
- Volunteers
- 300 people
- Sponsor
- Optain Health
Breast Cancer, Urine
Investigation of Urinary Biomarkers for the Detection of Breast Cancer
The aim of this study is to investigate and possibly validate urinary biomarkers for breast cancer. During this study the focus will be on aberrations of selected genes as prognostic or predictive value has been shown for these…
- Conditions
- Breast Cancer, Urine, Liquid Biopsy
- Trial name
- URODETECT-WP3 (NCT05453591)
- Testing
- Colli-Pee UAS devices
- Where
- Belgium
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Novosanis NV