Clinical trials: IMAGE
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
Allergic Conjunctivitis
Assessment of Alcon's Ocular Image Quantification System
The purpose of this study was to evaluate ocular responses with different allergen provocation methods.
- Trial name
- NCT01282138
- Testing
- Olopatadine hydrochloride, 0.1% ophthalmic solution (Patanol), Dextran 70 0.1%, hydroxypropyl methylcellulose 0.3% (Tears Naturale II)
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Alcon Research
Upper Extremity Tremor
123I-ALTROPANE® Reference Image Acquisition in Subjects With Diagnostically Uncertain Tremor
This study is designed to obtain an imaging training set that will be used to evaluate images in future trials. Currently, no radiopharmaceutical diagnostic imaging agent has been approved by the FDA in the U.S.
- Trial name
- AIM (NCT00596908)
- Where
- 7 sites in United States
- Volunteers
- 54 people
- Sponsor
- Alseres Pharmaceuticals, Inc
Breast Neoplasms
Delphinus SoftVue Prospective Case Collection - ARM 2
The SoftVue™ is a whole breast ultrasound system with an automated scanning curvilinear ring-array transducer that employs UST. It is currently cleared under FDA 510(k) K123209 and K142517 for use as both a B-mode ultrasonic…
- Trial name
- SV PCC ARM2 (NCT02977247)
- Testing
- Non-Interventional, Automated Whole Breast Ultrasound
- Where
- 10 sites in United States
- Volunteers
- 1,150 people
- Sponsor
- Delphinus Medical Technologies, Inc.
Subjects Referred to CT-examination of the Abdomen
A Randomized, Controlled Trial to Evaluate CT Image Quality Lumentin® 44
Subjects referred for abdominal or thoracoabdominal CT-examination will be randomised to either the three contrast agents Lumentin® 44, Omnipaque® or Movprep.
- Trial name
- NCT03326518
- Testing
- Lumentin® 44, Diluted Omnipaque®, Movprep®
- Where
- Sweden
- Volunteers
- 45 people
- Sponsor
- Lument AB
Diabetic Retinopathy, Retinal Vein Occlusion
Computer Aided Diagnosis of Multiple Eye Fundus Diseases From Color Fundus Photograph
Blindness can be caused by many ocular diseases, such as diabetic retinopathy, retinal vein occlusion, age-related macular degeneration, pathologic myopia and glaucoma.
- Conditions
- Diabetic Retinopathy, Retinal Vein Occlusion, Retinal Artery Occlusion, Central Serous Chorioretinopathy
- Trial name
- NCT04723160
- Testing
- Software assisted imaging diagnosis
- Where
- 5 sites in China
- Volunteers
- 748 people, healthy volunteers welcome
- Sponsor
- Visionary Intelligence Ltd.
High-Grade Glioma (WHO III-IV), Cerebral Vascular Conditions Requiring Surgical Intervention
Evaluation of Image Quality and Safety of the MyVeo Surgical Visualization Headset During Standard Neurosurgical and Reconstructive Procedures Using Compatible Microscopes.
This study looks at how well the MyVeo surgical visualization headset works during routine surgeries. MyVeo is a wearable device that helps surgeons see the surgical area in high detail, including blood flow and tissue…
- Conditions
- High-Grade Glioma (WHO III-IV), Cerebral Vascular Conditions Requiring Surgical Intervention, Conditions Requiring Plastic and Reconstructive Surgery
- Trial name
- IMED-MYVEO (NCT07164053)
- Testing
- MyVeo is an all-in-one surgical visualization headset used with compatible surgical microscopes and other medical imaging systems in the area of neurosurgery, ENT, spine, plastic and reconstructive su
- Where
- 2 sites in Spain, Switzerland
- Volunteers
- 32 people
- Sponsor
- Leica Microsystems (Schweiz) AG
Healthy
A Healthy Volunteer Trial Investigating MR-enterography Image Quality of Lumentin® 44
A healthy volunteer, open, PoC single center trial investigating a new oral contrast agent for use in combination of MR examination of the abdomen and pelvis.
- Trial name
- NCT05781490
- Testing
- Lumentin® 44 Powder for oral foam
- Where
- Sweden
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- Lument AB
Hepatic Tumor
Multicenter Study to Evaluate a New Robotic Device for Image-guided Percutaneous Needle Placement
This study evaluates the safety and performance of a new robotic device in the treatment of hepatic thermoablation in adults. The new robotic device will be used in all patients.
- Trial name
- NCT04230642
- Testing
- The Quantum Surgical device
- Where
- 2 sites in France
- Volunteers
- 22 people
- Sponsor
- Quantum Surgical
Growth, Neonates
Improving Artificial Intelligence-derived Algorithms for Estimating Length and Weight in NEonateS and infanTs up to 6 Months of Age (NEST)
The NEST study is a prospective, observational research study designed to collect clinical measurements and image data to develop and evaluate artificial intelligence (AI)-derived algorithms for estimating anthropometric…
- Conditions
- Growth, Neonates, AI (Artificial Intelligence)
- Trial name
- NEST (NCT07514182)
- Where
- Singapore
- Volunteers
- 60 people
- Sponsor
- Danone Asia Pacific Holdings Pte, Ltd.
MTBI - Mild Traumatic Brain Injury, Vestibular Disease
Effectiveness of VestAid App
This multi-center randomized trial (MCRT) will investigate the effectiveness of the VestAid application to provide equivalent or faster recovery from dizziness compared to standard-of-care delivery of vestibular rehabilitation…
- Conditions
- MTBI - Mild Traumatic Brain Injury, Vestibular Disease, Balance Deficits, Vestibular Disorders
- Trial name
- NCT06683417
- Testing
- Vestibular Rehabilitation Aid, Standard of care vestibular rehabilitation
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- BlueHalo
Neovascular Age-Related Macular Degeneration
A Non-interventional Study to Assess the Influence of Automated Optical Coherence Tomography Image Enrichment With Segmentation Information on Disease Activity Assessment in Patients Treated With Licensed Anti- VEGF Injections
RAZORBILL was an observational, multicenter, multinational, open-label, study designed primarily to investigate the influence of automated OCT image enrichment with segmentation information on disease activity assessment in nAMD…
- Trial name
- RAZORBILL (NCT04662944)
- Testing
- brolucizumab, ranibizumab, aflibercept
- Where
- 17 sites in Canada, Germany and 3 more
- Volunteers
- 494 people
- Sponsor
- Novartis Pharmaceuticals
No Condition
CLAiR Pivotal Study
This is a multi-site, observational clinical study to validate the performance of the CLAiR AI software in identifying elevated atherosclerotic cardiovascular disease (ASCVD) risk from retinal (eye) images obtained from two…
- Trial name
- NCT06808334
- Testing
- CLAIR
- Where
- United States
- Volunteers
- 942 people, healthy volunteers welcome
- Sponsor
- Toku Eyes Ltd
Breast Cancer
Clinical Evaluation of Opto-Acoustic Image Quality With the Gen1B Duplex Probe in Breast Applications
Comparative Evaluation of Gen1B (OA-16-1S) duplex OA/US probe versus Gen1 (OA-16-1) duplex OA/US probe in Healthy Subjects
- Trial name
- NCT03845907
- Testing
- Gen 1B, Gen 1
- Where
- United States
- Volunteers
- 4 people, healthy volunteers welcome
- Sponsor
- Seno Medical Instruments Inc.
Computed Tomography
Precise Image for Interventional CT
The purpose of this clinical study is to assess the performance of the Precise Image reconstruction algorithm on interventional CT images acquired from adult patients (>18 years old).
- Trial name
- NCT07317427
- Volunteers
- 55 people
- Sponsor
- Philips Clinical & Medical Affairs Global
Healthy
Bioequivalence Study Of Gabapentin Between Tablet And Liquid Formulation And The Food Effect Study Of Liquid Formulation
Primary objective for this study is to demonstrate bioequivalence between Japanese commercial tablet and Japanese commercial image liquid formulation.
- Trial name
- NCT00987779
- Testing
- Gabapentin
- Where
- Singapore
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Reconstructive Surgical Procedures, Plastic Surgery
Leica Microsystems Sponsored Study to Collect and Confirm Clinical Data on the Performance of the GLOW800 Device When Used in Accordance With Its Intended Use.
This post-market clinical follow-up (PMCF) study aims to confirm the safety and performance of the GLOW800 surgical microscope accessory when used in conjunction with the ARveo8x surgical microscope.
- Conditions
- Reconstructive Surgical Procedures, Plastic Surgery, Vascular Surgical Procedure, Cerebrovascular Disorder
- Trial name
- IMED-GLOW800 (NCT07164040)
- Testing
- The GLOW800, a non-contact, non-invasive device, allows the surgical microscope ARveo 8 and ARveo 8X to produce excitation light and resolve fluorescence emission from the fluorescent agent ICG
- Where
- 3 sites in Portugal, Spain and 1 more
- Volunteers
- 29 people
- Sponsor
- Leica Microsystems (Schweiz) AG
Healthy
Bioequivalence of Duvelisib and Food Effect on Pharmacokinetics of IPI-145
To Evaluate the Bioequivalence of the two formulations of IPI-145 and the Effect of Food on the Pharmacokinetics of IPI-145
- Trial name
- NCT02307461
- Testing
- IPI-145 (duvelisib), IPI-145
- Where
- United States
- Volunteers
- 103 people, healthy volunteers welcome
- Sponsor
- SecuraBio
Infertility
Eeva™ Pregnancy Investigational Clinical Study: A Postmarket Follow-Up Study
The purpose of this postmarket study is to gather data to evaluate the impact of using Eeva with traditional morphology grading on clinical pregnancy rates.
- Trial name
- EPIC (NCT01671644)
- Where
- 2 sites in Belgium, Netherlands
- Volunteers
- 104 people
- Sponsor
- Progyny, Inc.
Suspected Grade III and IV Gliomas Requiring Surgical Intervention, Neurosurgical Procedure
Leica Microsystems Sponsored PMCF Study to Collect and Confirm Clinical Data on the Performance of the GLOW400 Device When Used in Accordance With Its Intended Use
This post-market clinical follow-up (PMCF) study aims to confirm the safety and performance of the GLOW400 surgical microscope accessory when used in conjunction with the ARveo8x surgical microscope.
- Conditions
- Suspected Grade III and IV Gliomas Requiring Surgical Intervention, Neurosurgical Procedure, Glioma, Glioblastoma (GBM)
- Trial name
- IMED-GLOW400 (NCT07366892)
- Testing
- GLOW400 is a digital surgical microscope accessory used in fluorescent visualization of suspected grade III or IV gliomas during neurosurgery.
- Where
- 2 sites in Portugal, Switzerland
- Volunteers
- 37 people
- Sponsor
- Leica Microsystems (Schweiz) AG