Clinical trials: Performance, Detection, open to volunteers
- Condition Performance, Detection
- Status Open to volunteers
- Funder type Industry (pharma, biotech, devices)
Temperature Change, Body, Emergency Department Visit
Performance Study of the Thermodiag Solution for Body Temperature Measurement
The goal of this prospective, comparative, multi-centre interventional clinical investigation, is to evaluate the performance of the Thermodiag® medical device, compared with reference methods, for continuous measurement of core…
- Trial name
- ThermodiagPERF (NCT06703931)
- Testing
- Measures performed on all subjects
- Where
- 4 sites in France
- Volunteers
- 60 people
- Sponsor
- F2D Medical
In-stent Restenosis, Stent Fracture
Pilot Study of the α Prototype NIMBLE System: Feasibility, Safety, and Initial Performance in Non-Invasive Detection of Coronary In-Stent Restenosis
The NIMBLE-I study is a prospective, unicentric, single arm, feasibility clinical trial designed to evaluate a novel medical device for the non-invasive monitoring of coronary stents.
- Conditions
- In-stent Restenosis, Stent Fracture, Stent Complication
- Trial name
- NIMBLE-I (NCT06968858)
- Testing
- NIMBLE test
- Where
- Spain
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Nimble Diagnostics S.L.
Lung Cancer (Diagnosis)
Evaluate the Clinical Performance of the Flow Cytometry - FlowPath Lung Test as a Sensitive and Specific Non-invasive Diagnostic of Sputum Samples to Identify/Detect the Presence of Lung Cancer in High-risk Individuals Who Have Existing Lung Nodules, 6 to <30 mm in Diameter, Determined by LDCT.
Evaluate FlowPath Lung Diagnostic Test of Sputum Samples to Detect the Presence of Lung Cancer in High-risk Individuals Who Have Existing Lung Nodules, >6 to <30 mm in Diameter, Determined by LDCT.
- Trial name
- BA-004 (NCT07168993)
- Testing
- Standard medical treatment
- Where
- 11 sites in United States
- Volunteers
- 2,063 people
- Sponsor
- bioAffinity Technologies Inc.
Pancreas Cancer, Exosomes
ExoLuminate Study for Early Detection of Pancreatic Cancer
ExoLuminate is a nationally-enrolling registry study designed for earlier detection of cancer in patients at elevated risk or clinically-suspicious for pancreatic ductal adenocarcinoma (PDAC).
- Conditions
- Pancreas Cancer, Exosomes, Extracellular Vesicles, Pancreatic Neoplasms
- Trial name
- NCT05625529
- Where
- United States
- Volunteers
- 1,000 people
- Sponsor
- Biological Dynamics
Blood Stream Infection, Blood Stream Infections
Evaluation of Diagnostic Accuracy and Clinical Performance of the UllCORE Bloodstream Infection (BSI) Test
This study is designed to evaluate the clinical performance of the UllCORE Bloodstream Infection (BSI) Test, an investigational molecular diagnostic test intended to detect microorganisms and selected antimicrobial resistance…
- Conditions
- Blood Stream Infection, Blood Stream Infections, Sepsis, Fungemia
- Trial name
- B-RAPID (NCT07859852)
- Testing
- UllCORE BSI Test
- Where
- 20 sites in United States, France and 3 more
- Volunteers
- 1,500 people
- Sponsor
- Deepull Diagnostics S.L.
Colorectal Cancer, Colorectal Neoplasms
Clinical Performance of the Mainz Biomed Colorectal Cancer Screening Test for Colorectal Cancer and Advanced Adenoma
This study is to determine how the Mainz Biomed Colorectal Cancer Screening Test works when used in people aged ≥45 years of age and at an average risk of developing colorectal cancer.
- Conditions
- Colorectal Cancer, Colorectal Neoplasms, Colorectal Polyp, Colorectal Adenoma
- Trial name
- reconAAsense (NCT05636085)
- Testing
- Mainz Biomed Colorectal Cancer Screening Test
- Volunteers
- 15,000 people, healthy volunteers welcome
- Sponsor
- Mainz Biomed
Breast Cancer
Clinical Study to Assess the Safety and Performance of Kenko Breast AI+ Medical Device as an Aid to Breast Cancer Diagnosis in Adult Women
The goal of this observational study is to learn whether a new medical software tool called Kenko Breast AI+ can help healthcare professionals read breast magnetic resonance imaging (MRI) scans better to help diagnose breast…
- Trial name
- NCT07580105
- Testing
- Kenko Breast AI+
- Where
- Spain
- Volunteers
- 200 people
- Sponsor
- Kenko Imalytics S.L.
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
Breast Cancer
Post-market Evaluation of LumiSystem: Intraoperative Margin Performance and Clinical Utility (IMPACT) Registry
This is a minimal risk post-market registry study conducted at participating clinical institutions that are utilizing LumiSystem consistent with the U.S.
- Trial name
- IMPACT (NCT07616856)
- Where
- 2 sites in United States
- Volunteers
- 1,500 people
- Sponsor
- Lumicell, Inc.
Brain Metastases
Automated Detection of Brain Metastases on MRI
This reader study aims at assessing whether the radiologist aided with AI software has at least a non-inferior performance than without AI assistance in detecting brain metastases.
- Trial name
- BrainMets AI (NCT06727032)
- Testing
- Brain Metastasis AI
- Where
- Netherlands
- Volunteers
- 12 people
- Sponsor
- Robovision BV
Type 1 Diabetes Mellitus
Safety and Performance Evaluation of the SAVA Continuous Glucose Monitor for Effective Glucose Detection
The goal of this clinical trial is to evaluate the safety and performance of the SAVA Continuous Glucose Monitor across glucose ranges over a period of 15-day wear in adults over 18 years of age with Type 1 Diabetes.
- Trial name
- SPEED (NCT07679347)
- Testing
- CGM Devices
- Volunteers
- 20 people
- Sponsor
- SAVA Technologies Ltd.
Esophageal Cancer, Gastric Cancer (GC)
Using 18F-FAPI PET to Detect Metastatic Disease in Patients That Have Gastric or Esophageal Cancer.
This is a multi-site, open-label, non-randomized, single dose study to assess the clinical utility of [¹⁸F]FAPI-74 PET/CT in the detection of metastatic disease in individuals with pathologically confirmed gastric…
- Conditions
- Esophageal Cancer, Gastric Cancer (GC), Gastroesophageal Junction
- Trial name
- FAPI-GO (NCT07217704)
- Testing
- [18F]FAPI-74 PET/CT
- Where
- 19 sites in United States
- Volunteers
- 200 people
- Sponsor
- SOFIE
Colorectal Cancer
Multicentre Study for Data Collection, Development, and Evaluation of Novel CRC Screening and Diagnostic Methods
The primary goal is to develop easy accessible diagnostic tools for high risk subjects for colon cancer in different European populations to improve early CRC detection.
- Trial name
- NCT06515821
- Testing
- ONCOSCREEN
- Where
- 8 sites in Bulgaria, France and 4 more
- Volunteers
- 4,100 people
- Sponsor
- Firalis SA
Bloodstream Infection, Sepsis
Clinical Performance Study of Microbio InfectID-BSI for Detection of Bacteria and Yeast With Patient Blood Samples
The objective of the study is to determine the efficacy of the Microbio InfectID-BSI qPCR kit in a clinical laboratory environment using patient whole blood for pathogen detection and identification versus standard of care…
- Conditions
- Bloodstream Infection, Sepsis, Septic Shock
- Trial name
- IID-BSIqPCR (NCT06531031)
- Testing
- InfectID-BSI (Bloodstream Infection) qPCR Assay
- Where
- 8 sites in United States, Australia and 1 more
- Volunteers
- 1,500 people
- Sponsor
- Microbio Co Ltd
Colorectal Cancer, Gastric Cancers
Study to Evaluate the Diagnostic Performance of GEH300079 (68Ga) Injection PET/CT for Detection of PC in Patients With Colorectal, Gastric, Ovarian, or Pancreatic Cancers (PERISCOPE)
This study is a Phase 2/3, prospective, multicenter, open-label, non-randomized clinical trial, in which GEH300079 (68Ga) PET/CT images will be acquired in patients with primary colorectal, gastric, ovarian, or Pancreatic Ductal…
- Conditions
- Colorectal Cancer, Gastric Cancers, Ovarian Cancers, Pancreatic Ductal Adenocarcinoma
- Trial name
- NCT07219238
- Testing
- GEH300079 (68Ga) Injection Positron-Emission Tomography (PET)/Computed Tomography (CT)
- Where
- 2 sites in United States, Sweden
- Volunteers
- 175 people
- Sponsor
- GE Healthcare
Melanoma and Other Malignant Neoplasms of Skin, Basal Cell Carcinoma of Skin
TruScore Standalone Clinical Study
The goal of this clinical trial is to evaluate if the TruScore device can accurately diagnose suspicious skin lesions in patients aged 22 years and older.
- Conditions
- Melanoma and Other Malignant Neoplasms of Skin, Basal Cell Carcinoma of Skin, Squamous Cell Carcinoma of the Skin
- Trial name
- Standalone (NCT06793423)
- Testing
- Skin lesion diagnostic device evaluation
- Where
- 6 sites in United States
- Volunteers
- 464 people
- Sponsor
- VeriSkin, Inc.
Hemolysis
Feasibility Performance Study of ABL90 FLEX PLUS HEM
This feasibility performance study evaluates the ABL90 FLEX PLUS HEM device for its analytical performance in a clinical setting. The study aims to evaluate the performance of the hemolysis detection feature.
- Trial name
- ABL90FLEXHEM (NCT07345091)
- Testing
- The purpose of this study is to investigate the performance of the hemolysis detection function on the ABL90 FLEX PLUS HEM using arterial or venous whole blood
- Where
- Denmark
- Volunteers
- 95 people
- Sponsor
- Radiometer Medical ApS
Pancreatic Ductal Adenocarcinoma (PDAC)
Using 18F-FAPI PET to Detect Metastatic Disease in Patients That Have Pancreatic Ductal Adenocarcinoma (PDAC)
This is a multi-site, open-label, non-randomized, single dose study to assess the clinical utility of [¹⁸F]FAPI-74 PET/CT in the detection of metastatic disease in individuals with pathologically confirmed pancreatic ductal…
- Trial name
- FAPI-PRO (NCT07217717)
- Testing
- [18F]FAPI-74 PET/CT
- Where
- 19 sites in United States
- Volunteers
- 200 people
- Sponsor
- SOFIE
Pancreatic Ductal Adenocarcinoma (PDAC)
Panuri Performance Study
The main purpose of the study is to assess the performance of the Panuri test in detecting pancreatic ductal adenocarcinoma (PDAC) the most common type of pancreatic cancer that accounts for approximately 90% of all pancreatic…
- Trial name
- NCT07587866
- Testing
- Panuri test
- Where
- 32 sites in Hungary, Italy and 1 more
- Volunteers
- 1,100 people
- Sponsor
- Urteste S.A
Quality of Life, Epilepsy (treatment Refractory)
Evaluation of the Epilepsy-related Quality of Life, Seizure-related Accidents and Validation of the Mjn-SERAS Solution in the Normalised Patient Environment with Real-World Data
The study will be prospective, multicentre, postmarketing clinical study, with a controlled and randomized design, to perform the analysis of 130 subjects with a clinical diagnosis of epilepsy, patients whose clinical semiology…
- Trial name
- SERAS_Home_RWD (NCT05845255)
- Testing
- mjn-SERAS
- Where
- 6 sites in Germany, Spain and 1 more
- Volunteers
- 130 people
- Sponsor
- MJN Neuroserveis, S.L