Clinical trials: Diagnostic Accuracy
Arrhythmia, Palpitations
7-Day MEMO Patch Monitoring for Arrhythmia Detection in Patients With Palpitations
"This exploratory prospective clinical study aims to evaluate the diagnostic yield of a 7-day adhesive electrocardiographic (ECG) monitoring device (MEMO Patch) in detecting cardiac arrhythmias in patients presenting with…
- Conditions
- Arrhythmia, Palpitations, Syncope
- Trial name
- NCT07728552
- Testing
- MEMO Patch, 24-Hour Holter Monitor
- Where
- South Korea
- Volunteers
- 60 people
- Sponsor
- HUINNO Co., Ltd
Amyotrophic Lateral Sclerosis (ALS)
A Study to Evaluate the Performance of a Diagnostic Test in ALS
Prospective multicenter study of subjects who were recently diagnosed with amyotrophic lateral sclerosis (ALS) or another neurodegenerative disease (including spinal cord diseases, muscle diseases and neurological diseases such…
- Trial name
- NCT02759913
- Testing
- Lumbar puncture
- Where
- United States
- Volunteers
- 300 people
- Sponsor
- Iron Horse Diagnostics, Inc.
NASH - Nonalcoholic Steatohepatitis
Non-Invasive Quantification of Liver Health in NASH (N-QUAN)
To evaluate, in patients with suspected NASH referred for liver biopsy, the diagnostic performance of CT1 at discriminating those with NAS≥4 \& F≥2 from those without.
- Trial name
- NCT04054310
- Testing
- Liver Multi Scan
- Where
- 7 sites in United States
- Volunteers
- 225 people
- Sponsor
- Perspectum
Influenza -Like Illness, Influenza A
Home Testing of Respiratory Illness
The main goal of this research study is to use data from activity trackers (such as Fitbits), lab tests, and surveys to see if activity, sleep, and heart rate data can tell the difference between when someone has a respiratory…
- Conditions
- Influenza -Like Illness, Influenza A, Influenza Type B, Respiratory Viral Infection
- Trial name
- NCT04245800
- Where
- United States
- Volunteers
- 5,233 people, healthy volunteers welcome
- Sponsor
- Evidation Health
Parkinsonian Syndromes
Two Separate But Identical Studies Evaluating the Safety and Efficacy of ALTROPANE® in the Use of SPECT Imaging for Upper Extremity Tremor
This will be two separate but identical studies: ALSE-A-02a, ALSE-A02b. Each study is designed to evaluate the diagnostic accuracy and safety of a single dose of 123I-ALTROPANE® in subjects with upper extremity tremor for less…
- Trial name
- POET-2 (NCT00724906)
- Testing
- 123 I - ALTROPANE®
- Where
- United States
- Volunteers
- 240 people
- Sponsor
- Alseres Pharmaceuticals, Inc
Lung Cancer
A Phase 3 Study of 99mTC-EC-DG SPECT/CT Versus PET/CT in Lung Cancer
The purpose of this study is to determine if the images of the primary lesions of lung cancer and any metastatic lesions seen from the investigational SPECT/CT 99mTC-EC-DG scans are the same as the PET/CT 18F-FDG scans.
- Trial name
- NCT01394679
- Testing
- (99m Tc) ECDG (Ethylenedicysteine-Deoxyglucose), 18 F FDG followed by PET/CT imaging
- Where
- United States
- Volunteers
- 154 people
- Sponsor
- Cell>Point LLC
Intracranial Neoplasm
Accuracy of Robotically Assisted Cranial Biopsies
This is an observational post-market study determining biopsy accuracy in a clinical environment using Cirq® Robotic Alignment Module Cranial.
- Trial name
- NCT05891002
- Testing
- Cirq® Robotic Alignment Module Cranial
- Where
- France
- Volunteers
- 4 people
- Sponsor
- Brainlab AG
Tuberculosis (TB)
QuantiFERON Access Clinical Performance Study Protocol
Approximately 225 samples, obtained from participants with varying risk factors for TB infection and disease, will be tested using the QFT Access Kit and the comparator device QFT-Plus.
- Trial name
- NCT04243031
- Testing
- QFT Access
- Volunteers
- healthy volunteers welcome
- Sponsor
- QIAGEN Gaithersburg, Inc
Fever, Respiratory Tract Infections
Diagnostic Accuracy of a Host-response Based Diagnostic Tool for Distinguishing Between Bacterial and Viral Etiologies in Pediatric Patients
This is a prospective clinical validation study of a novel regulatory approved (CE-IVD) diagnostic assay called ImmunoXpert™ that will enroll 1222 pediatric patients.
- Trial name
- AutoPilot (NCT03052088)
- Where
- 2 sites in Germany, Italy
- Volunteers
- 1,140 people
- Sponsor
- MeMed Diagnostics Ltd.
Breast Cancer
Case Collection Study to Support Digital Mammography Image Software Change
The primary objective of this study is to compare image processing software to support a new image processing software application for a full-field digital mammography (FFDM) system.
- Trial name
- LIP2SIP (NCT00756496)
- Testing
- Mammography screening and diagnosis
- Volunteers
- 442 people, healthy volunteers welcome
- Sponsor
- Siemens Medical Solutions USA - CSG
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.
Prostate Cancer
Study of 18F-DCFPyL PET/CT Imaging in Patients With Prostate Cancer
This study evaluates the safety and diagnostic performance of 18F-DCFPyL Injection in patients with at least high risk prostate cancer who are planned for radical prostatectomy with lymphadenectomy (Cohort A) or in patients with…
- Trial name
- OSPREY (NCT02981368)
- Testing
- 18F-DCFPyL Injection, PET/CT imaging
- Where
- 10 sites in United States, Canada
- Volunteers
- 385 people
- Sponsor
- Progenics Pharmaceuticals, Inc.
Atopic Asthma
Determination of Accuracy in Measurement of Total Immunoglobulin E Using a Test Device in Atopic Subjects
The purpose of this study is to determine the accuracy of the Novel point of care test (POCT) total IgE assay in atopic patients. 120 patients with atopic conditions and approximately 40 healthy subjects will be enrolled.
- Trial name
- NCT02758548
- Testing
- Blood sample, POCT device
- Where
- 12 sites in Germany, Italy and 3 more
- Volunteers
- 193 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Prostate Cancer
A Phase 2 Study With MIP-1404 in Men With High-Risk PC Scheduled for RP and EPLND Compared to Histopathology
This was a multicenter, multi-reader, open-label, Phase 2 study assessing the safety and performance characteristics of MIP 1404 imaging in the detection of prostate gland and pelvic lymph node cancer.
- Trial name
- NCT01667536
- Testing
- Drug: 99mTc-MIP-1404
- Where
- 35 sites in United States, Belgium and 6 more
- Volunteers
- 105 people
- Sponsor
- Molecular Insight Pharmaceuticals, Inc.
Melanoma (Skin), Basal Cell Carcinoma of the Skin
Elucid Labs AIDA™ - Labelled Image Acquisition Protocol
Diagnosis of melanoma involves physical examination of the lesion with many dermatologists adjunctively employing dermoscopes. The rate of misdiagnosis of melanoma remains significant, along with a high rate of referral to…
- Conditions
- Melanoma (Skin), Basal Cell Carcinoma of the Skin, Squamous Cell Carcinoma of the Skin
- Trial name
- NCT03621462
- Testing
- Artificial Intelligence Dermatology Assistant (AIDA™)
- Where
- Canada
- Volunteers
- 4,000 people
- Sponsor
- Elucid Labs Inc.
Thyroid
A Prospective, Single-arm, Multi-centre, Blinded, Observational, Diagnostic Accuracy Study With a Diagnostic Medical Product
After thyroid surgery, 0.6 to 4% of patients develop postoperative bleeding. 90% of this postoperative bleeding occurs within the first 48 hours.
- Trial name
- HEDOS (NCT04845867)
- Testing
- ISAR-M THYRO
- Where
- Germany
- Volunteers
- 1,470 people
- Sponsor
- ISAR-M GmbH
Otitis Media Acute
Clinical Development of Deep Learning for the OtoSight
The objective of this study is to clinically develop and evaluate a machine learning approach to improve the performance and data interpretation of the PhotoniCare OtoSight Middle Ear Scope in pediatric patients presenting at the…
- Trial name
- NCT04722770
- Testing
- PhotoniCare OtoSight Middle Ear Scope
- Where
- United States
- Volunteers
- 188 people, healthy volunteers welcome
- Sponsor
- PhotoniCare, Inc.
Acute Myocardial Infarction (AMI)
SpinChip Hs-cTnI Multisite Precision
During a heart attack, the protein troponin I is released from the heart muscle into the bloodstream. Measurements of cardiac troponin in blood are used as an aid in the diagnosis of heart attack.
- Trial name
- HEAT-1 (NCT06851013)
- Testing
- SpinChip hs-cTnI
- Where
- 3 sites in Norway
- Volunteers
- 37 people
- Sponsor
- SpinChip Diagnostics ASA
Coronary Artery Disease
Diagnostic Accuracy to Detect Hemodynamically Significant Stenosis by Non-invasive SURECardio CT-FFR
The aim of this study was to determine the diagnostic accuracy of SURECardio CT-FFR to detect functionally significant coronary stenosis.
- Trial name
- NCT03055780
- Testing
- CT-FFR. CTA. FFR
- Volunteers
- 59 people
- Sponsor
- Toshiba Medical Systems Corporation, Japan
Out of Hospital Cardiac Arrest
CAOCT: Intra CoronAry Optical Computerized Tomography in out-of Hospital Cardiac Arrest Patients
Out-of-hospital cardiac arrest (OHCA) is a leading cause of sudden death in Europe and the United States. Mortality is currently close to 40% among those patients who had been successfully resuscitated after OHCA associated with…
- Trial name
- NCT04431661
- Testing
- Optical Coherence Tomography, Coronary Angiography, Per cutaneous coronary intervention
- Where
- 7 sites in Belgium, France and 1 more
- Volunteers
- 28 people
- Sponsor
- Ceric Sàrl