Clinical trials: Ultrasound Performance
Liver Fibrosis
Liver Fibrosis Assessment With ShearWave Elastography
Chronic liver disease/fibrosis can be the result of various causes, and the result is that the liver tissue becomes stiff. ShearWave™ elastography, available on the Aixplorer® ultrasound system, is a method that can be used to…
- Trial name
- NCT02181452
- Where
- 13 sites in Belgium, China and 7 more
- Volunteers
- 2,333 people
- Sponsor
- SuperSonic Imagine
Healthy, Osteopenia
Clinical Study to Predict the Risk of Bone Fractures With the POROUS Ultrasound Device
Osteoporosis is a widespread medical condition among older people. It causes the bones to weaken and become more likely to break.
- Conditions
- Healthy, Osteopenia, Osteoporosis
- Trial name
- POROUS-preFX (NCT06567054)
- Testing
- Measurements with the POROUS R3C ultrasound device at the midshaft tibia, DXA measurement of the hip and lumbar spine, DXA-based Vertebral Fracture Assessment (VFA)
- Where
- 6 sites in Austria, Germany and 1 more
- Volunteers
- 1,600 people, healthy volunteers welcome
- Sponsor
- POROUS GmbH
Breast Cancer
HydroMARK Post-market Clinical Follow-up Study
The purpose of this study is to assess the safety and performance of the HydroMARK Breast Biopsy Site Marker manufactured in the Devicor Medical Products, Inc. Tijuana facility.
- Trial name
- NCT04622696
- Testing
- Ultrasound imaging
- Where
- 3 sites in United States
- Volunteers
- 730 people, healthy volunteers welcome
- Sponsor
- Devicor Medical Products, Inc.
Breast Cancer, Breast Diseases
Evaluation of TaiHao Breast Ultrasound Diagnosis Software RN-CES Descartes
A standard of truth "SOT" is determined based on the interpretation results of the case data by interpretation experts, and the SOT is compared with the detection results of this program's function for detecting suspected breast…
- Trial name
- NCT05792475
- Testing
- Define Standard of Truth (SOT) by Taihao Breast Cancer Diagnostic Software
- Where
- Taiwan
- Volunteers
- 3 people
- Sponsor
- TaiHao Medical Inc.
Trigger Finger, Trigger Thumb
Clinical Investigation on Safety, Performance and Effectiveness of Sono-instruments
Carpal Tunnel (CT) syndrome is a collection of characteristic symptoms and signs that occurs following compression of the median nerve within the CT.
- Conditions
- Trigger Finger, Trigger Thumb, Carpal Tunnel Syndrome
- Trial name
- SONO-01 (NCT05435950)
- Testing
- Sono-Intruments
- Where
- Belgium
- Volunteers
- 30 people
- Sponsor
- Spirecut
Respiratory Failure
Multicenter, Multinational, Follow-Up Clinical Trial of the Performance of RESPINOR DXT to Identify Patients at Increased Risk of Weaning Failure
The study will be a multicenter, multinational, prospective single arm blinded non-interventional follow-up study (from DXT-CS-005) to validate RESPINOR DXT's performance to identify patients at increased risk of weaning failure…
- Trial name
- DE-RISK WF II (NCT05580185)
- Testing
- RESPINOR DXT
- Where
- 8 sites in France, Norway
- Volunteers
- 145 people
- Sponsor
- Respinor AS
Liver Fibrosis
ShearWave™ Elastography to Assess Liver Fibrosis in Chinese Patients With Hepatitis B
This study will evaluate how liver stiffness measurements made with ShearWave™ Elastography (SWE) correspond with a biopsy result (currently the gold standard).
- Trial name
- NCT02313649
- Where
- 15 sites in China
- Volunteers
- 447 people
- Sponsor
- SuperSonic Imagine
Musculoskeletal Disorders, Skeletal Disorder
Observational Prospective PMCF Study to Confirm Performance and Safety of Intelect® Devices in Real World
DJO UK Ltd (ENOVIS) is conducting this study to confirm the performance and safety of the Chattanooga Intelect® devices in real world use.
- Conditions
- Musculoskeletal Disorders, Skeletal Disorder, Muscle Disorder
- Trial name
- INTELECT (NCT06809283)
- Where
- 4 sites in France, Italy and 1 more
- Volunteers
- 144 people
- Sponsor
- DJO UK Ltd
Healthy
Medicsen Smartpatch: Safety & Performance (SOUNDD)
The goal of this clinical trial is to understand the efficacy of Medicsen's Smartpatch to deliver drugs through the skin in healthy volunteers.
- Trial name
- SOUNDD (NCT07615959)
- Testing
- Medicsen Smartpatch, Subcutaneous (SC) single dose
- Where
- Spain
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Medicsensors S.L
Respiratory Failure
Multicenter, Multinational, Clinical Trial of the Performance of RESPINOR DXT to Identify Patients at Increased Risk of Weaning Failure
The study will be a multicenter, multinational, prospective single arm blinded study to validate DXT's performance to identify patients at increased risk of weaning failure during the spontaneous breathing trial (SBT).
- Trial name
- DE-RISK WF (NCT04696406)
- Testing
- RESPINOR DXT
- Where
- 9 sites in France, Italy and 1 more
- Volunteers
- 193 people
- Sponsor
- Respinor AS
Hypertension, Resistant to Conventional Therapy
Continued Safety and Performance of the TIVUS System
The TIVUS II is a prospective, multicenter, non-randomized, open-label clinical study of the safety and performance of the TIVUS™ System consisting of three (3) concurrent cohorts: TIVUS™ Severe Resistant HTN Cohort TIVUS™…
- Trial name
- NCT01835535
- Testing
- TIVUS
- Where
- Australia
- Volunteers
- 80 people
- Sponsor
- Cardiosonic
Breast Cancer
CRRS-4 Pivotal Somo•v™ ABUS ROC Reader Observer Study
To determine the impact on Interpreting Physician performance in detecting breast cancer, as defined by the area under the Receiver Operating Characteristic Curve (ROC), when Automated Breast Ultrasound (ABUS) and screening…
- Trial name
- NCT01424956
- Testing
- Automated Breast Ultrasound (ABUS)
- Where
- United States
- Volunteers
- 17 people, healthy volunteers welcome
- Sponsor
- U-Systems, Inc.
Breast Cancer Detection, Dense Breast Parenchyma
Delphinus SoftVue™ ROC Reader Study (DMT SV RRS3)
The purpose of this multi-reader, multi-case (MRMC) reader study is to evaluate reader performance when SoftVue™ automated breast ultrasound and screening mammography are combined, compared to screening mammography alone, in…
- Conditions
- Breast Cancer Detection, Dense Breast Parenchyma, Benign Breast Findings, Normal Breast Screening
- Trial name
- DMT SV RRS3 (NCT04260620)
- Testing
- Reading of Automated Breast Ultrasound in conjunction with Screening Mammography
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Delphinus Medical Technologies, Inc.
Benign, Malignant Tumors or Other Soft Tissue Removal, Nephrectomy or Partial Nephrectomy With Parenchyma Removal
The CUSA Clarity Soft Tissue Removal Study
To investigate the clinical performance and surgeon preferences of the CUSA® Clarity Ultrasonic Surgical Aspirator System for soft tissue removal during surgical procedures.
- Trial name
- NCT04298268
- Testing
- CUSA Clarity Ultrasonic Surgical Aspirator System use
- Where
- 5 sites in Germany, Italy
- Volunteers
- 100 people
- Sponsor
- Integra LifeSciences Corporation
Arrhythmia
Perclose Multi-Access Duplex Ultrasound (DUS) Study
The aim of this prospective, single-arm, United States (US) multi-center, descriptive clinical study is to evaluate the safety of multiple access site closure in a single vein with the SMC System by scheduled DUS at discharge and…
- Trial name
- NCT04904809
- Testing
- Perclose ProGlide SMC System and/or Perclose ProStyle SMCR System
- Where
- 2 sites in United States
- Volunteers
- 36 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Disease
The StUdy to Evaluate the Performance and safEty of the Novasight HybRid System Using Objective PeRformance Criteria
This prospective, multicenter, single-arm study aims to evaluate the safety, operability and practicability of the novel hybrid intravascular imaging system/catheter during the percutaneous transluminal coronary intervention.
- Trial name
- SUPERIOR (NCT04617899)
- Testing
- Intravascular imaging
- Where
- 4 sites in China
- Volunteers
- 120 people
- Sponsor
- CardioNavi MedTech (Wuhan) Co., Ltd.
Hepatocellular Carcinoma, Hepatocellular Cancer
ALTUS: Performance of a Multi- Target Hepatocellular Carcinoma (HCC) Test in Subjects With Increased Risk
The primary objective is to assess overall sensitivity and specificity of Oncoguard™ Liver for hepatocellular cancer (HCC) detection in a surveillance population.
- Conditions
- Hepatocellular Carcinoma, Hepatocellular Cancer, Hepatitis B, Cirrhosis
- Trial name
- NCT05064553
- Testing
- Study CT/MRI Imaging, Standard of Care CT/MRI Imaging, Oncoguard™ Liver Test
- Where
- 76 sites in United States
- Volunteers
- 2,990 people
- Sponsor
- Exact Sciences Corporation
Breast Cancer, Breast Neoplasms
Delphinus SoftVue™ ROC Reader Study
The purpose of this multi-reader, multi-case (MRMC) reader study is to evaluate reader performance when SoftVue™ automated breast ultrasound and screening mammography are combined, compared to screening mammography alone, in…
- Trial name
- DMT SV RRS1 (NCT03698942)
- Testing
- Reading of Automated Breast Ultrasound in conjunction with Screening Mammography
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- Delphinus Medical Technologies, Inc.
Echocardiography
Clinical Performance Evaluation of a Diagnostic Ultrasound System
Subjects who are required to undergo transesophageal echocardiography according to the current clinical practice standards will be eligible for enrollment.
- Trial name
- NCT07066449
- Where
- China
- Volunteers
- 60 people
- Sponsor
- GE Healthcare
Ventricular Dysfunction, Left, Ventricular Function, Left
Federated Learning for Point-of-Care Cardiac Ultrasound
This prospective, multicenter study will evaluate a federated machine-learning system designed to analyze focused cardiac point-of-care ultrasound examinations.
- Conditions
- Ventricular Dysfunction, Left, Ventricular Function, Left, Echocardiography, Ultrasonography
- Trial name
- FL-POCUS (NCT07800962)
- Testing
- Focused Cardiac Point-of-Care Ultrasonography, FL-POCUS Federated Machine-Learning Analysis System
- Where
- United States
- Volunteers
- 3,000 people
- Sponsor
- Truway Health, Inc.