Clinical trials: Optical Imaging
Undergoing Esophagogastroduodenoscopy (EGD)
High Resolution Optical Imaging of the Esophagus Using the Nvision Volumetric Laser Endomicroscopy (VLE™) Imaging System
This is a single center, single arm, open label observational trial of patients undergoing EGD. The primary objective of this clinical trial is to evaluate the ability of physicians to position the NvisionVLE catheter to acquire…
- Trial name
- NCT01844921
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- NinePoint Medical
Coronary Artery Disease, Bifurcation Lesion
Using 3D Imaging to Optimize Bifurcation Stenting
The primary purpose of this study is to determine whether bifurcation stenting guided by on-line three-dimensional optical frequency domain imaging (3D-OFDI) is superior to that with angiographic guidance by measuring incomplete…
- Trial name
- NCT02972489
- Testing
- 3D OFDI guidance arm, Angio guidance arm
- Where
- 2 sites in Japan, Netherlands
- Volunteers
- 106 people
- Sponsor
- Increase Co., Ltd.
Skin Lesion
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
- NCT02193581
- Testing
- MDS
- Where
- Israel
- Volunteers
- 50 people
- Sponsor
- Orlucent, Inc
Atherectomy in Diseased Lower Extremity Arteries
OptiCal COherence ToMography ABoard InformiNg AtherEctomy
This is a prospective, multi-center, non-randomized single arm feasibility trial of the Wolverine OCT guided atherectomy system.The trial will enroll up to 50 subjects diagnosed with peripheral vascular disease of the lower…
- Trial name
- COMBINE (NCT01775410)
- Testing
- Wolverine System to perform atherectomy
- Where
- 2 sites in Colombia
- Volunteers
- 4 people
- Sponsor
- Avinger, Inc.
Breast Cancer
Computed Optical Margin Assessment for Breast Cancer Surgery, Phase I (Part A)
This multi-center, prospective, open label study analyzed specimens from fifty subjects at two study sites. Patients scheduled to undergo breast-conserving surgery were recruited in accordance with the inclusion and exclusion…
- Trial name
- NCT01699867
- Testing
- Optical coherence tomography
- Where
- 2 sites in United States
- Volunteers
- 50 people
- Sponsor
- Diagnostic Photonics, Inc.
Hydration
Feasibility of Using the Gatorade Sports Science Institute (GSSI) Labs App for Hydration Related Outcomes
This remote study will evaluate the feasibility of using the Gatorade Sports Science Institute (GSSI) Labs App for remotely collecting hydration related outcomes.
- Trial name
- NCT07005895
- Testing
- Hydration assessment via mobile app
- Where
- United States
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- PepsiCo Global R&D
Ulcer Foot, Diabetes
Optical Imaging For Assessment of Foot Perfusion
This study is designed to evaluate the ability of Spatial Frequency Domain Imaging (SFDI) to measure perfusion in lower extremities and to understand how it might be used in a podiatry clinic.
- Trial name
- NCT03144050
- Testing
- SFDI Imaging
- Where
- United States
- Volunteers
- 400 people, healthy volunteers welcome
- Sponsor
- Modulated Imaging Inc.
Glaucoma, Retinal Disease
Nidek RS3000 Comparative Study
The primary objective of this clinical study is to compare the Nidek RS-3000 Optical Coherence Tomography (OCT) device to the Optovue RTVue OCT.
- Conditions
- Glaucoma, Retinal Disease, Corneal Disease
- Trial name
- NCT01384487
- Where
- United States
- Volunteers
- 89 people, healthy volunteers welcome
- Sponsor
- Nidek Co. LTD.
Coronary Artery Disease
Vis-Rx Post-Market Evaluation
Post-market clinical evaluation of the Gentuity High-Frequency Optical Coherence Tomography (HF-OCT) System and the Vis-Rx Micro-Imaging Catheter for use in Percutaneous Coronary Intervention (PCI) procedures.
- Trial name
- Vis-Rx PME (NCT04533503)
- Testing
- HF-OCT Imaging with the Vis-Rx Micro-Imaging Catheter
- Where
- 3 sites in United States
- Volunteers
- 257 people
- Sponsor
- Gentuity, LLC
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.
Breast Cancer Female
Wide-field Optical Coherence Tomography Imaging of Excised Breast Tissue.
This is a single-arm, multi-center data collection study designed to collect WF-OCT imaging data of excised breast tissue margins with corresponding margin status from histopathology.
- Trial name
- NCT04242277
- Testing
- Investigational WF-OCT device
- Where
- 2 sites in United States
- Volunteers
- 198 people
- Sponsor
- Perimeter Medical Imaging
Coronary Artery Disease (CAD)
Imaging of Coronary Plaques in Participants Treated With Evolocumab
To evaluate the effect of evolocumab on fibrous cap thickness (FCT) in participants with non-ST-elevation acute coronary syndrome (NSTE-ACS) who are taking maximally tolerated statin therapy.
- Trial name
- NCT03570697
- Testing
- Evolocumab, Statin therapy
- Where
- 33 sites in United States, Australia and 5 more
- Volunteers
- 164 people
- Sponsor
- Amgen
Barrett's Esophagus
High Resolution Optical Imaging of Barrett's Esophagus Using Nvision Volumetric Laser Endomicroscopy (VLE)
The primary objective of this clinical trial is to evaluate the performance of the Nvision Volumetric Laser Endomicroscopy (VLE) system to visualize subsurface tissue in subjects undergoing esophagogastroduodenoscopy (EGD) and to…
- Trial name
- NCT01503411
- Where
- 3 sites in United States
- Volunteers
- 120 people
- Sponsor
- NinePoint Medical
Undergoing Esophagogastroduodenoscopy (EGD)
High Resolution Optical Imaging of the Esophagus Using the NvisionVLE™ Imaging System
This is a single center, single arm, open label observational trial of patients undergoing EGD. The primary objective of this clinical trial is to evaluate the ability of physicians to position the NvisionVLE Optical Probe to…
- Trial name
- NCT02031900
- Testing
- NvisionVLE Imaging System: NvisionVLE Imaging Console, NvisionVLE Optical Probe and Inflation Accessory Kit
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- NinePoint Medical
Peripheral Arterial Disease
Evaluation of the Pantheris Atherectomy System
A non-randomized, prospective, global clinical trial of the Avinger Pantheris System, an atherectomy device that provides directional visualization and imaging as an adjunct to fluoroscopy to aid removal of plaque in diseased…
- Trial name
- VISION (NCT01937351)
- Testing
- Pantheris System
- Where
- 21 sites in United States, Germany
- Volunteers
- 162 people
- Sponsor
- Avinger, Inc.
Conductive Hearing Loss, Sensorineural Hearing Loss
Middle Ear Optical Coherence Tomography Imaging and Vibrometry in Patients With Hearing Loss
This study involves imaging ears with hearing loss with a new system that allows the user to see the middle ear bones and measure their movement in response to sound.
- Trial name
- NCT07732920
- Testing
- OCT - clear
- Where
- 2 sites in Canada
- Volunteers
- 500 people
- Sponsor
- Audioptics Medical Incorporated
Coronary Artery Disease
Multicentre Registry of CCTA, IVUS and OCT
The Invictus Registry will compare the diagnostic performance of coronary computed tomography angiography (CCTA) versus intravascular imaging by intravenous ultrasound (IVUS) or optical coherence tomography (OCT) for the…
- Trial name
- NCT04066062
- Where
- 9 sites in Japan
- Volunteers
- 1,700 people
- Sponsor
- Cleerly, Inc.
Diabetic Retinopathy, Retinal Imaging
Real-time Eye Tracking and Imaging of the Eye in Diabetic Retinopathy Patients
Diabetic retinopathy (DR) is a leading cause of vision loss in working age Canadians. Current treatment consists of early detection and laser photocoagulation therapy for preventing progressive or severe vision loss.
- Trial name
- NCT05608265
- Testing
- OSNAT 800 IO
- Where
- Canada
- Volunteers
- 60 people
- Sponsor
- PulseMedica
Geographic Atrophy
A Study to Optimize Subretinal Surgical Delivery and to Evaluate Safety and Activity of Opregen in Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration (GAlette); Adaptive Optics (AO) Retinal Imaging Substudy in Association With Study GR44251
This study will evaluate the success and safety of subretinal surgical delivery as well as the preliminary activity of OpRegen in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).
- Trial name
- NCT05626114
- Testing
- OpRegen
- Where
- 17 sites in United States, Israel
- Volunteers
- 60 people
- Sponsor
- Genentech, Inc.
Coronary Artery Disease, Acute Myocardial Infarction (AMI)
Effects of Ziltivekimab on Coronary Atherosclerotic Burden in Patients With Acute Myocardial Infarction
Despite improvements in the treatment, coronary artery disease (CAD) remains one of the leading causes of death worldwide. Around 20% of people who have suffered a heart attack (myocardial infarction) need to be hospitalized…
- Conditions
- Coronary Artery Disease, Acute Myocardial Infarction (AMI), Coronary Atherosclerosis of Native Coronary Artery
- Trial name
- ZEPHYR (NCT07276282)
- Testing
- Ziltivekimab
- Where
- Switzerland
- Volunteers
- 332 people
- Sponsor
- ECRI bv