Clinical trials: Optical Imaging
Transthyretin Amyloid Cardiomyopathy
Retinal Fundus Imaging and OCT Imaging for Ocular Detection of ATTR-CM
This multicenter pilot study will enroll adult participants with a confirmed clinical diagnosis of transthyretin amyloid cardiomyopathy (ATTR-CM) and heart failure (HF) controls with documentation within the past 2 years that…
- Trial name
- NCT07690436
- Where
- 20 sites in United States, Germany and 3 more
- Volunteers
- 500 people
- Sponsor
- AstraZeneca
Myocardial Infarction
A Research Study to Look at the Effect of Ziltivekimab on Plaque in the Blood Vessels of the Heart, Compared to Placebo, in People With a Heart Attack
The study is testing the effect of ziltivekimab on reducing plaque in the blood vessels of the heart, specifically aiming to manage or reduce atherosclerotic plaque.
- Trial name
- ZEPHYR (NCT07301034)
- Testing
- Ziltivekimab
- Where
- 20 sites in Austria, Denmark and 4 more
- Volunteers
- 332 people
- Sponsor
- Novo Nordisk A/S
Neuromyelitis Optica Spectrum Disorder, NMOSD
A Study In Neuromyelitis Optica Spectrum Disorder (NMOSD) With Satralizumab As An Intervention
Objective of the trial is to describe the efficacy and safety of satralizumab in patients with aquaporin-4 (AQP4) antibody seropositive NMOSD, either treatment naive or inadequate responders to previous treatment with rituximab…
- Trial name
- SAkuraBonsai (NCT05269667)
- Testing
- Satralizumab 120 mg
- Where
- 3 sites in United States, South Korea and 1 more
- Volunteers
- 4 people
- Sponsor
- Hoffmann-La Roche
Breast Cancer
Adjunctive Efficacy Study Of The SoftScan® Optical Breast Imaging System
The primary study endpoint -SoftScan adjunctive accuracy- will be used to test the hypothesis that the adjunctive combination of the SoftScan with x-ray mammography provides diagnostic accuracy that is significantly better than…
- Trial name
- NCT00267449
- Testing
- SoftScan Optical Breast Imaging System
- Where
- 6 sites in United States, Canada
- Volunteers
- 950 people, healthy volunteers welcome
- Sponsor
- ART Advanced Research Technologies Inc.
Coronary Artery Disease, Coronary Stenosis
ILUMIEN IV: OPTIMAL Percutaneous Coronary Intervention (PCI)
The objective of this prospective, single-blind clinical investigation is to demonstrate the superiority of an Optical Coherence Tomography (OCT)-guided stent implantation strategy as compared to an angiography-guided stent…
- Conditions
- Coronary Artery Disease, Coronary Stenosis, Atherosclerosis, STEMI
- Trial name
- NCT03507777
- Testing
- Coronary PCI guided by OCT, Coronary PCI guided by Angiography
- Where
- 90 sites in United States, Australia and 18 more
- Volunteers
- 2,487 people
- Sponsor
- Abbott Medical Devices
Coronary Artery Disease
Optical Frequency Domain Imaging (OFDI) Assessed Strut Coverage of New Terumo DES
Purpose of this study is to evaluate, after implantation of a drug eluting stent (DES), coverage of the stent struts by new tissue.
- Trial name
- DISCOVERY123 (NCT01844843)
- Testing
- TCD-10023 drug eluting stent
- Where
- 6 sites in France, Germany and 1 more
- Volunteers
- 60 people
- Sponsor
- Terumo Europe N.V.
Breast Cancer
Computed Optical Margin Assessment for Breast Cancer Surgery, Phase I (Part B)
This intraoperative study is a prospective study analyzing specimens from fifty subjects. Patients scheduled to undergo breast-conserving surgery will be recruited in accordance with the inclusion and exclusion criteria.
- Trial name
- NCT02313116
- Testing
- Interferometric Synthetic Aperture Microscopy
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Diagnostic Photonics, Inc.
Breast Cancer, Breast Tumor
Evaluating Investigational Medical Device for Breast Tumor Diagnosis Using Diffusion Optical Spectroscopy
This is a multicenter, pivotal clinical trial to evaluate the safety and efficacy of a diagnostic device used to assist in the differentiation of breast tumors in patients with breast lesions detected by ultrasound alone or by…
- Conditions
- Breast Cancer, Breast Tumor, Mammary Carcinoma, Human
- Trial name
- ORIGO (NCT06597175)
- Testing
- ORIGO
- Where
- 5 sites in South Korea
- Volunteers
- 300 people
- Sponsor
- Olive Healthcare
Esophagogastroduodenoscopy
NvisionVLE™ Registry System Registry
Prospective, multi-site registry with longitudinal follow up for patients undergoing EGD or endoscopy. The primary objective is to provide a collection of patient NvisionVLE™ procedural data for participating physicians…
- Trial name
- NCT02215291
- Where
- 18 sites in United States
- Volunteers
- 1,000 people
- Sponsor
- NinePoint Medical
Subarachnoid Hemorrhage, Optical Imaging
A New Multi-parameter Neuromonitoring System to Save Patients' Lives in Stroke and Brain Injury
To assess the feasibility of a new neuromonitoring system (NeMoSystem including NeMo Probe and NeMo Patch) and the accuracy of the measurement values (cerebral blood flow (CBF); cerebral blood volume (CBV)) obtained.
- Trial name
- NCT01802762
- Testing
- NeMo Patch and NeMo Probe
- Where
- 2 sites in Austria, Switzerland
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- NeMoDevices AG
Dehydration
Transdermal Optical Imaging (TOI) as a Non-invasive Measure to Detect Changes in Hydration Status in Healthy Adults and Athletes
The primary objective of this study is to analyze smart phone-based Transdermal Optical Imaging (TOI) features to develop a model that can discern hydration status, including: 1) at various timepoints throughout a 24-hour period…
- Trial name
- NCT06212518
- Testing
- GENPOP ad libitum fluid intake, GENPOP fluid restriction, ATHLETE ad libitum fluid intake
- Where
- 4 sites in United States
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- PepsiCo Global R&D
Amputation Wound, Peripheral Arterial Disease
Wound Imaging Study to Gather Clinical References for a Device to Assist Selecting Level-of-amputation in PAD Patients
This is a proof-of-concept study to collect images to train a CADe algorithm to predict the correct level of amputation in individuals scheduled for amputation secondary to PAD.
- Trial name
- WISCR (NCT03611361)
- Testing
- SpectralMD DeepView Wound Imaging System 2.0
- Where
- United States
- Volunteers
- 55 people
- Sponsor
- SpectralMD
Cataract
Check of Optical Features and Accuracy of the Zeiss ZO Lens After Selection and Calculation With OKULIX
It is planned to implant the intraocular lenses XL Stabi ZO and Invent ZO into the eyes of patients for whom a cataract operation is medically indicated. The lenses are marketed and CE certified.
- Trial name
- ZO Okulix (NCT00842959)
- Testing
- Invent ZO, XL Stabi ZO
- Where
- Germany
- Volunteers
- 120 people
- Sponsor
- Carl Zeiss Meditec AG
High-Grade Glioma (WHO III-IV)
FG001 Near-Infrared Fluorescence Imaging During Tumor Resection in Newly Diagnosed High-Grade Glioma
This clinical trial aims to determine if FG001 can assist surgeons in identifying the difference between tumor and healthy tissue during surgery in participants with newly diagnosed high-grade glioma.
- Trial name
- NCT07609472
- Testing
- FG001
- Where
- 5 sites in United States
- Volunteers
- 76 people
- Sponsor
- FluoGuide A/S
Peripheral Arterial Disease
Trial of Pantheris System, an Atherectomy Device That Provides Imaging While Removing Plaque in Lower Extremity Arteries
To evaluate the safety and effectiveness of the Pantheris System to perform atherectomy while using directional visualization and imaging as an adjunct to fluoroscopy to aid removal of plaque from diseased lower extremity…
- Trial name
- COMBINE-II (NCT02126540)
- Testing
- Pantheris Atherectomy System
- Where
- New Zealand
- Sponsor
- Avinger, Inc.
Dehydration
Utility of Transdermal Optical Imaging (TOI) as a Non-invasive Measure of Hydration Status: Phase 3a for Model Development
The primary objective of this study is to analyze smart phone-based Transdermal Optical Imaging (TOI) features to develop a model that can discern hypohydration from euhydration status including 1) a small feasibility study for…
- Trial name
- NCT06044610
- Testing
- GENPOP Passive dehydration (75% reduction in fluid intake, GENPOP Ad lib fluid intake, EXERCISE without fluid replacement
- Where
- 2 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- PepsiCo Global R&D
Left-sided Colorectal Resection : Diverticular Diseases, Left-sided Colorectal Resection : Colonic Neoplasms
InTRaoperative Imaging DEvice Based on endogeNous opTical Properties to Evaluate Bowel Oxygenation in Colorectal Resections
The objective of the study is to assess the safety and technical feasibility of a new imaging system, used during colorectal resection surgery, named Trident in version 1.0, which could be used by the surgeon during colorectal…
- Conditions
- Left-sided Colorectal Resection : Diverticular Diseases, Left-sided Colorectal Resection : Colonic Neoplasms, Left-sided Colorectal Resection : Rectal Neoplasms
- Trial name
- TRIDENT (NCT05973227)
- Testing
- use of the TRIDENT system
- Where
- France
- Volunteers
- 10 people
- Sponsor
- Intuitive Surgical
Skin Lesions
Non-invasive Melanoma Assessment Using a Topical Fluorescence Reagent and Optical Imaging
The use of MDS to access the presence of melanoma in the skin.
- Trial name
- NCT02056522
- Where
- 2 sites in Israel
- Volunteers
- 357 people
- Sponsor
- Orlucent, Inc
Coronary Artery Disease, Myocardial Infarction
Randomized Study to Assess the Effect of ThRombus Aspiration on Flow Area in STEMI Patients
The purpose of the study it to evaluate whether primary percutaneous coronary intervention (primary PCI) with a new thrombectomy device as compared to primary PCI without thrombectomy increases minimal flow area after stenting…
- Conditions
- Coronary Artery Disease, Myocardial Infarction, STEMI
- Trial name
- TROFI (NCT01271361)
- Testing
- primary PCI with thrombectomy, primary PCI without thrombectomy
- Where
- 5 sites in Denmark, France and 2 more
- Volunteers
- 140 people
- Sponsor
- Terumo Europe N.V.
Peripheral Artery Disease
Evaluation of Imaging of Peripheral Arteries by Optical Coherence Tomography and Intravascular Ultrasound Imaging
A non inferiority trial to determine the capability of optical coherence tomography (OCT) imaging to show vessel morphology in comparison to imaging provided by intravascular ultrasound imaging (IVUS).
- Trial name
- SCAN (NCT03480685)
- Testing
- IVUS and OCT Imaging
- Where
- 2 sites in United States
- Volunteers
- 12 people
- Sponsor
- Avinger, Inc.