Clinical trials: Performance, Detection
Pregnancy Related, Premature Birth
Mueller Polarimetric Colposcopy for High-performance Detection of Cervical Changes During Pregnancy
Mueller polarimetric colposcopy appears to be a powerful tool for evaluating cervical microstructure modification during pregnancy. Some polarimetric parameters of the uterine cervix can be correlated with the gestational age.
- Trial name
- COLPOTERME (NCT04661553)
- Testing
- Mueller's polarimetric colposcopy "Group 1", Mueller's polarimetric colposcopy "Group 2"
- Where
- France
- Volunteers
- 683 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Cancer
Pan-canceR Early DetectIon projeCT
PREDICT is a prospective, multi-center study for the early detection of pan-cancer through cell-free DNA (cfDNA) methylation based model, in which approximately 14,000 participants will be enrolled.
- Trial name
- PREDICT (NCT04383353)
- Where
- 3 sites in China
- Volunteers
- 14,026 people, healthy volunteers welcome
- Sponsor
- Guangzhou Burning Rock Dx Co., Ltd.
Melanoma (Skin)
Melanoma Detection in Switzerland With VECTRA
This study is to compare 2D- and 3D-imaging and routine clinical care in early melanoma detection in a prospective large-scale real-world data set.
- Trial name
- MELVEC (NCT04605822)
- Testing
- 3D imaging Total Body Photography Vectra® WB360, 2D imaging FotoFinder ATBM® Master imaging system, Smartphone application (SkinVision®)
- Where
- Switzerland
- Volunteers
- 455 people
- Sponsor
- University Hospital, Basel, Switzerland
Fever Malaria
Clinical Evaluation of the STANDARD™ Q Malaria/CRP Duo Test
The aim of this study is to assess the clinical performance (sensitivity, specificity, positive and negative predictive values) of the STANDARD™ Q Malaria/CRP Duo Test when used by health care workers (HW) in a point of care…
- Trial name
- NCT04791800
- Testing
- Malaria/CRP combination test
- Where
- India
- Volunteers
- 1,808 people
- Sponsor
- Foundation for Innovative New Diagnostics, Switzerland
Arrhythmias, Cardiac
Automated Diagnostic Performance of Smartwatch ECG for Arrhythmia Detection Using the PulseAI Neural Network.
The study is to evaluate the performance of the PulseAI neural network technology at interpreting ECG data recorded using a single-lead Smartwatch (Apple Watch).
- Trial name
- NCT05668377
- Testing
- PulseAI ECG Platform
- Where
- Ireland
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- PulseAI Ltd
Colorectal Cancer, Adenoma Colon
Real-time Computer-Aided Detection of Colonic Adenomas With NEC WISE VISION® Endoscopy
This is a prospective, multicenter, randomized study to evaluate the clinical performance of a novel CADe device, WISE VISION® Endoscopy System, in patients undergoing high-definition white light (HDWL) colonoscopy for screening…
- Conditions
- Colorectal Cancer, Adenoma Colon, Polyp of Colon
- Trial name
- COLOWISE (NCT05611151)
- Testing
- Computer Aided Detection (CADe)
- Where
- 5 sites in United States, Germany and 2 more
- Volunteers
- 830 people
- Sponsor
- NEC Corporation
High Sensitivity and Specificity (With 95% Confidence Interval) of RealDetect™ COVID-19 RT-PCR Kit
Performance Evaluation of RealDetect™ COVID-19 RT-PCR Kit for the Detection of SARS-CoV-2 Virus
The novel Severe acute respiratory syndrome coronavirus 2 (SARS-C0V 2) originated in Wuhan, China in December 2019. As of April 15 2020, the virus has spread across 213 countries/territories with 1,914,916 cases and 123,010…
- Trial name
- NCT04403672
- Testing
- performance evaluation study of RealDetect RT-PCR Kit for COVID-19 detection
- Where
- Bangladesh
- Volunteers
- 120 people
- Sponsor
- Bangladesh Medical Research Council (BMRC)
Hepatocellular Carcinoma by AJCC Stage
Performance Evaluation (Sensitivity/Specificity) of HelioLiver Test for Detection of HCC
De-identified whole blood and serum samples are collected for the purpose of evaluating the performance (sensitivity/specificity) of the HelioLiver Test for the detection of hepatocellular carcinoma (HCC).
- Trial name
- ENCORE (NCT05059665)
- Testing
- Helio Liver Test
- Where
- 2 sites in China
- Volunteers
- 290 people, healthy volunteers welcome
- Sponsor
- Helio Genomics
Healthy
Clinical Performance of Masimo INVSENSOR00057 for Atrial Fibrillation Detection
This study is designed to validate the performance of Masimo INVSENSOR00057 in detecting atrial fibrillation. The noninvasive ECG measurements will be compared to results obtained from an FDA-cleared ECG monitor.
- Trial name
- NCT05476250
- Testing
- INVSENSOR00057
- Where
- United States
- Volunteers
- 120 people, healthy volunteers welcome
- Sponsor
- Masimo Corporation
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.
Hepatocellular Carcinoma (HCC)
Hepatocellular Carcinoma 3 Gene Methylation Combination Detection Kit (PCR Fluorescent Probe Method) Multicenter Clinical Trial
This clinical trial aims to systematically evaluate the clinical performance and accuracy of the HepaAiQ test kit, a multi-gene methylation assay based on PCR with fluorescent probe detection.
- Trial name
- NCT06842563
- Where
- China
- Volunteers
- 900 people
- Sponsor
- Singlera Genomics Inc.
Paraneoplastic Neurological Syndrome, Autoimmune Encephalitis
Diagnostic Performance of a Commercial Assay for the Detection of Neuronal Antibodies
Detection of autoantibodies targeting neuronal surface or intracellular antigens is a keystone for the diagnosis and the treatment of auto-immune encephalitis and paraneoplastic neurological syndromes.
- Trial name
- IFINEURO (NCT05783947)
- Testing
- Indirect immunofluorescence assay on tissue slides and cell-based assays with CSF and/or sera
- Where
- 2 sites in France
- Volunteers
- 34 people
- Sponsor
- Hospices Civils de Lyon
Alzheimer's Disease
[18F]MK-3328 as a Possible Novel Positron Emission Tomography (PET) Tracer for the Detection of Brain Amyloid Plaques (MK-3328-002)
The purpose of this study is to evaluate radiolabeled [18F]MK-3328 as a PET tracer for estimating the regional distribution and extent of amyloid plaques in participants suffering from amnestic mild cognitive impairment (aMCI)…
- Trial name
- NCT01385033
- Testing
- [18F]MK-3328
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Merck Sharp & Dohme LLC
Gynecologic Cancer
PERformance of Multi-Cancer Early-detectIon Based on Various Biomarkers in fEmale Cancers, PERCEIVE-II
This study is a prospective study aimed to validate the performance of combined multi-omitcs assays for early detection of gynecologic cancers.
- Trial name
- NCT06001099
- Where
- China
- Volunteers
- 2,935 people, healthy volunteers welcome
- Sponsor
- Fudan University
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.
TB - Tuberculosis
Start Taking Action for Tuberculosis in Kids
Start4Kids: Evaluating the performance, feasibility, acceptability and cost effectiveness of computer-aided detection (CAD) of chest X-ray (CXR) and concurrent testing using novel diagnostics and non-sputum specimens for…
- Trial name
- Start4Kids (NCT07248423)
- Testing
- Xpert MTB/RIF Ultra, Truenat, MTB, Truenat MTB Plus
- Volunteers
- 7,920 people, healthy volunteers welcome
- Sponsor
- Liverpool School of Tropical Medicine
Sars-CoV2, RT-PCR
Detection of COVID-19 in Saliva Collection
Since December 2019, the world has faced a pandemic of COVID-19, an infectious disease caused by SARS-CoV-2, a virus that emerged in China.
- Conditions
- Sars-CoV2, RT-PCR, Saliva Collection, Nasopharyngeal Sample
- Trial name
- SALICOV (NCT04386551)
- Where
- France
- Volunteers
- 501 people
- Sponsor
- Centre Hospitalier Universitaire, Amiens
Skin Cancer
Multi-Center Study to Evaluate the Performance of DermDx for Primary Care Physicians in the Detection of Skin Cancers
The proposed study is a pivotal, multi-center retrospective reader study designed to determine whether the use of DermDx as a concurrent reading aid improves the performance of primary care physicians (PCPs) in diagnosing skin…
- Trial name
- NCT06463860
- Testing
- DermDx
- Where
- United States
- Volunteers
- 81 people, healthy volunteers welcome
- Sponsor
- MetaOptima Technology Inc.
Neisseria Gonorrhoeae Infection, Chlamydia Trachomatis Infection
Performance of Nucleic Acid Amplification Tests for the Detection of NG and CT
The purpose of this study was to use participant samples to simultaneously evaluate three nucleic acid amplification tests (NAATs) diagnostic platforms.
- Conditions
- Neisseria Gonorrhoeae Infection, Chlamydia Trachomatis Infection, Sexually Transmitted Infections
- Trial name
- pNAAT (NCT02870101)
- Testing
- Nucleic acid amplification test 1 for NG and CT, Nucleic acid amplification test 2 for NG and CT, Nucleic acid amplification test 3 for NG and CT
- Where
- 9 sites in United States
- Volunteers
- 2,767 people, healthy volunteers welcome
- Sponsor
- Duke University
Stroke, Parkinson Disease
Videofluoroscopic Swallowing Study (VFSS)
The study procedure of simultaneous VFSS and DDS measurement will be completed in one day and the subject will be followed within 2 business days after the study procedure to monitor for adverse events.
- Conditions
- Stroke, Parkinson Disease, Multiple Sclerosis, Oropharyngeal Dysphagia
- Trial name
- PORSCHE (NCT03387267)
- Testing
- Dysphagia Detection System
- Where
- 13 sites in United States, Finland
- Volunteers
- 452 people
- Sponsor
- Société des Produits Nestlé (SPN)