Clinical trials: Diagnostic Equipment
The Evaluation of a New MD - Combined PET-MR System
The New Combined PET-MR System NextGen PET-MR With Syngo MR XA80A: Evaluation of Diagnostic Image Quality and Usability (Software and Hardware) in the Clinical Setting.
This clinical investigation is used to evaluate the novel PET-MR scanner and it is a clinical investigation under MDR. The focus is on the evaluation of the diagnostic image quality in a clinical setting, considering the speed of…
- Trial name
- NCT06666387
- Testing
- PET-MR examination
- Where
- Denmark
- Volunteers
- 65 people
- Sponsor
- Siemens Healthcare A/S
Diabetic Foot Ulcer, Venous Leg Ulcer
DETEC® pH Point of Care Wound Diagnostic Test
The purpose of this study is to determine the relationship between wound alkalinity and the non-healing status of chronic ulcer wounds.
- Conditions
- Diabetic Foot Ulcer, Venous Leg Ulcer, Pressure Ulcer, Wound, Non-Healed
- Trial name
- NCT04614038
- Testing
- DETEC® pH
- Where
- 2 sites in United States
- Volunteers
- 450 people
- Sponsor
- Progenitec Inc.
Endometrium Cancer
Development of a Molecular Diagnostic Tool for Endometrial Cancer.
WomEC is an in vitro diagnostic test for Endometrial Cancer (EC) based on the detection of the expression level of a combination of 5 proteins in the soluble fraction of a pipelle biopsy specimen.
- Trial name
- NCT06192017
- Testing
- WomEC
- Where
- 26 sites in Spain
- Volunteers
- 1,950 people
- Sponsor
- MiMARK Diagnostics, S.L.
PTSD - Post Traumatic Stress Disorder
REVEAL Study - Diagnostic Testing for PTSD Using the Senseye Diagnostic Tool
The goal of the REVEAL PTSD study is to test how well the Senseye DT works as a diagnostic test for Post-traumatic Stress Disorder (PTSD) in adults 18 and older who are experiencing one or more symptoms that might be related to…
- Trial name
- NCT07280065
- Testing
- Senseye Diagnostic Tool (DT), Clinician Administered PTSD Scale for DSM-5, Revised Version
- Where
- 6 sites in United States, Australia
- Volunteers
- 1,900 people, healthy volunteers welcome
- Sponsor
- Senseye, Inc.
Wound, Wound Infection
The Use of Biochemical Analyzes to Monitor the Development of Wounds
Chronic wounds represent a growing challenge in medical care. Part 1: The aim of this part of the study was to collect wound swabs and to answer the question whether the rapid diagnostic tool using enzyme activities can display…
- Conditions
- Wound, Wound Infection, Wound Contamination, Diagnostic Techniques and Procedures
- Trial name
- NPWW (NCT04507724)
- Where
- Austria
- Volunteers
- 41 people
- Sponsor
- Qualizyme Diagnostics GmbH & Co KG
Pregnancy Related, Mental Health Issue
MamaConecta: Digital Tool for Maternal Mental Health
The goal of this randomized controlled trial is to validate a digital health tool, Dana app, that enhances well-being and supports mental health monitoring for women during the perinatal period.
- Conditions
- Pregnancy Related, Mental Health Issue, Postpartum Depression, Postpartum Anxiety
- Trial name
- DDT (NCT06442774)
- Testing
- Mobile application, Monitoring via wearable
- Where
- 3 sites in Spain
- Volunteers
- 1,200 people, healthy volunteers welcome
- Sponsor
- A Thousand Colibris, S.L
Compartment Syndrome
Assessment of Near Infrared Spectroscopy as a Diagnostic Tool in Acute Compartment Syndrome
The purpose of this study is to define the reliability and accuracy of Near Infrared Spectroscopy (NIRS) in the detection of intra-compartmental tissue perfusion in injured and noninjured extremities over time.
- Trial name
- NCT01077934
- Testing
- near-infrared spectroscopy
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- J&M Shuler
Viral Infection, Bacterial Infections
A Controlled, Blinded Study to Validate the Diagnostic Accuracy and Assess the Clinical Utility of a Host-response Based Diagnostic Tool for Distinguishing Between Bacterial and Viral Etiologies in Pediatric Patients Presenting to the ED With Suspicion of Acute Infection
To externally validate the diagnostic accuracy and assess the clinical utility of a host-response based diagnostic tool called ImmunoXpert™, for differentiating between bacterial and viral etiologies in pediatric patients >3…
- Conditions
- Viral Infection, Bacterial Infections, Antibiotic Misuse, Host Response Diagnostics
- Trial name
- ROSETTA (NCT04254991)
- Testing
- ImmunoXpert™
- Volunteers
- 525 people
- Sponsor
- MeMed Diagnostics Ltd.
PTSD
Senseye's OBCI Diagnostic Tool for PTSD
This pilot study will investigate the feasibility, acceptability, repeatability, accuracy and efficacy of the Senseye OBCI diagnostic tool to assess the presence and severity of PTSD symptoms and monitor response to…
- Trial name
- NCT05372523
- Testing
- CAPS-5 Assessment, Senseye OBCI
- Where
- United States
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- Senseye, Inc.
Tropical Infectious Diseases
Optimizing Sysmex Technology as an Innovative Tool to Differentiate Between Malaria (PALUdism) and BACterial Infections in a Malaria Endemic Region
Severe malaria and bacterial Blood Stream Infections (bBSI) are impossible to differentiate clinically. This poses a particular threat in low resource areas, where bBSI is often not diagnosed due to the unavailability of rapid…
- Trial name
- PALUBAC (NCT02669823)
- Testing
- None, treatment as actual best practice
- Where
- Burkina Faso
- Volunteers
- 930 people
- Sponsor
- Sysmex Europe GmbH
Wounds
Impact of Oxidized Silver Wound Dressings on Wound Bacteria
Chronic non-healing wounds considerably impact quality of life in affected patients and are a substantial burden on the Canadian health care system.
- Trial name
- NCT02662101
- Testing
- Exsalt SD7, Exsalt T7 Wound Dressing
- Volunteers
- 17 people
- Sponsor
- Exciton Technologies Inc.
Skin Lesions, Melanocytic Nevi
Evaluating an Artificial Intelligence Tool to Help Primary Care Doctors Diagnose Skin Conditions.
This study aims to determine if an artificial intelligence (AI) medical device can help primary care doctors more accurately identify and manage various skin conditions.
- Conditions
- Skin Lesions, Melanocytic Nevi, Melanoma (Skin Cancer), Basal Cell Carcinoma of Skin
- Trial name
- LegitHealth PH (NCT07428941)
- Testing
- AI-based medical device for aided diagnosis in dermatological conditions
- Where
- Spain
- Volunteers
- 9 people
- Sponsor
- AI Labs Group S.L
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
Acute Pain
Single Ascending Dose Study of Two Liquidia Bupivacaine Formulations
This study is designed to assess and characterize the safety and tolerability profile of LIQ865A and LIQ865B formulations compared to diluent or aqueous bupivacaine hydrochloride when infiltrated into a defined area of the medial…
- Trial name
- NCT02982889
- Testing
- LIQ865A bupivacaine formulation, LIQ865B bupivacaine formulation, Diluent for LIQ865
- Where
- Denmark
- Volunteers
- 29 people, healthy volunteers welcome
- Sponsor
- Liquidia Technologies, Inc.
Diabetic Retinopathy
RETeval Study for Diabetic Retinopathy
RETeval is a new handheld device intended to detect vision threatening diabetic retinopathy. The purpose of this study is to calibrate RETeval, and then measure its ability to detect vision threatening diabetic retinopathy.
- Trial name
- NCT01950663
- Testing
- RETeval
- Where
- 2 sites in United States
- Volunteers
- 468 people
- Sponsor
- Inoveon Corporation
Stroke, Acute Ischemic Stroke
Validation of Velocity Curvature Index as a Diagnostic Biomarker Tool for Assessment of Large Vessel Stroke
This study is a multi-center, multi-phase, multi-cohort, prospective, randomized, open, blinded endpoint (PROBE), non-significant risk (NSR) device study including up to 420 evaluable subjects measured with the study device(s)…
- Trial name
- VOICE (NCT05547412)
- Testing
- NovaGuide 2 Intelligent Ultrasound System
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- NeuraSignal Inc dba NovaSignal
Plaque Psoriasis, Psoriatic Arthritis
Modifying PEST for Psoriatic Arthritis Screening
The purpose of this study is to assess the impact of adding two questions and pictures to the validated PEST on the potential diagnosis of PsA in participants with moderate-to-severe plaque PsO in Canada.
- Trial name
- ScreenX (NCT06382051)
- Testing
- PEST Screening group
- Where
- 30 sites in Canada
- Volunteers
- 502 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals
Breast Cancer
The PIONEER-01 Study of the Imagio Breast Imaging System
This is a prospective controlled multi-center study involving gray scale (B-mode) ultrasound vs OA/US (opto-acoustic and gray scale ultrasound) for the visualization of suspicious masses.
- Trial name
- NCT01943916
- Testing
- Imagio OA/US (US and OA/US), Imagio gray scale ultrasound
- Where
- 16 sites in United States
- Volunteers
- 2,105 people
- Sponsor
- Seno Medical Instruments Inc.
Endometrial Receptivity
The ERA Test as a Diagnostic Guide for Personalized Embryo Transfer
This project seeks to demonstrate the clinical value of the personalised diagnosis of the endometrial factor in infertility.
- Trial name
- ERA RCT (NCT01954758)
- Testing
- personalized Embryo Transfer (pET), Frozen Embryo Transfer (FET), Fresh Embryo Transfer (ET)
- Where
- 16 sites in Belgium, Brazil and 5 more
- Volunteers
- 569 people
- Sponsor
- Igenomix
PTSD, Generalized Anxiety Disorder
Feasibility and ML Training Investigation of the Senseye DT for Diagnosis of Adults with PTSD
The aim of this study is to obtain data on the feasibility of the Senseye Diagnostic Tool (DT) to assess the presence and severity of post-traumatic stress disorder (PTSD) symptoms.
- Conditions
- PTSD, Generalized Anxiety Disorder, Major Depressive Disorder
- Trial name
- NCT05717439
- Testing
- CAPS-5-R, Senseye DT
- Where
- 5 sites in United States
- Volunteers
- 338 people, healthy volunteers welcome
- Sponsor
- Senseye, Inc.