1. Articles in category: Clinical Trials

    1-24 of 518 1 2 3 4 ... 20 21 22 »
    1. First-In-Human Intracoronary OCT-FLIm In Patients Undergoing PCI

      First-In-Human Intracoronary OCT-FLIm In Patients Undergoing PCI

      Patients will undergo intracoronary imaging using combined optical coherence tomography- fluorescence lifetime imaging (OCT-FLIm) during percutaneous coronary intervention, and the obtained imaging data will be used to assess the efficacy of this dual-modal catheter imaging strategy in characterizing high-risk plaque.

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      Mentions: Korea University
    2. Non-invasive Photoacoustic Imaging of Skin Inflammatory Disorders With Machine Learning-assisted Scoring

      Non-invasive Photoacoustic Imaging of Skin Inflammatory Disorders With Machine Learning-assisted Scoring

      Inflammatory skin disorders are usually assessed by disease scoring system such as Scoring AD (SCORAD)/Eczema Area and Severity Index (EASI) and Psoriasis Area and Severity Index (PASI) for atopic eczema and psoriasis respectively. The current approach to score the severity of these inflammatory skin disorders is through clinical observations and questionnaires. These scores however do not reflect the structural characteristics of the skin such as morphology, vasculature architecture and dermis thickness and are subject to inter and intra-assessor variability. Objective inflammatory diseases indicators through non-invasive imaging techniques have the potential to be an important clinical tool to shed light ...

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    3. Prediction and Validation of Clinical Course of Coronary Artery Disease With CT-Derived Non-Invasive Hemodynamic Phenotyping and Plaque Characterization

      Prediction and Validation of Clinical Course of Coronary Artery Disease With CT-Derived Non-Invasive Hemodynamic Phenotyping and Plaque Characterization

      Acute coronary syndrome (ACS) and sudden cardiac death can be the first manifestation of coronary artery disease and are the leading cause of death in the majority of the world's population. The main pathophysiology of ACS is well-known and fibrous cap thickness, presence of a lipid core, and the degree of inflammation have been proposed as the key determinants of plaque vulnerability.(1) Previous studies using virtual histology intravascular ultrasound or optical coherence tomography showed that clinical application of this concept improved risk prediction of ACS.(2) However, these approaches have not been widely adopted in daily practice due ...

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    4. Intraoperative Optical Coherence Tomography - Normals

      Intraoperative Optical Coherence Tomography - Normals

      Optical coherence tomography (OCT) is an established technology for ophthalmic diagnosis which can perform noncontact, noninvasive, real time, cross-sectional imaging of the retina and anterior eye. OCT has displaced ophthalmoscopy and stereo-photography as the gold-standard for clinical assessment and documentation of retinal microanatomy including thickness, cystoid structures, subretinal fluid and retinal traction. Despite these benefits, new technologies can still benefit patients including increasing the resolution, imaging speed, and contrast of OCT technologies. Since 2013, Dr. Tao's group has worked to develop and translate new ophthalmic imaging technologies. The goal of this proposal is to develop novel OCT technology for ...

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    5. Validation Study of RETINA-AI Galaxy™, an Automated Diabetic Retinopathy Screening Device

      Validation Study of RETINA-AI Galaxy™, an Automated Diabetic Retinopathy Screening Device

      Diabetes affects approximately 35 million Americans, each of whom needs at least one retinal exam per year. However, majority do not get their eye exam due to multiple prohibitive factors such as cost, transportation, difficulty of taking time off from work, and inconvenience, amongst others. The standard of care in diabetes requires at least an annual eye exam to detect onset of diabetic retinopathy and to treat when indicated. This is important as diabetes is the most common cause of visual impairment and blindness in working age adults in the United States. There are too few trained professionals to diagnose ...

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      Mentions: UC Davis FDA RetinAI
    6. Study of Innovative Multimodal Imaging Biomarkers to Predict Anatomical Outcome in Naive Patients With wAMD Treated With Brolucizumab.

      Study of Innovative Multimodal Imaging Biomarkers to Predict Anatomical Outcome in Naive Patients With wAMD Treated With Brolucizumab.

      The purpose of this phase IV study is to identify innovative early imaging parameters as predictors of the long-term clinical response to brolucizumab in terms of fluid resolution in patients with wet Age-related Macular Degeneration (wAMD) with the purpose to evaluate their potential in supporting the treatment regimen choice (q12w or q8w).

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    7. Multicenter Phenotype-Genotype Analysis of Vascular Stains to Optimize Treatment Utilizing Optical Coherence Tomography

      Multicenter Phenotype-Genotype Analysis of Vascular Stains to Optimize Treatment Utilizing Optical Coherence Tomography

      The purpose of this research study is to develop a better understanding of vascular stains and to improve the usual laser treatment for vascular stain by using optical coherence tomography (OCT). This study is being done at the University of Wisconsin-Madison (UW-Madison) and University of California, Irvine. A total of about 85 people will participate in this study.

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    8. Optical Coherence Tomography-Guided PCI With Single-Antiplatelet Therapy

      Optical Coherence Tomography-Guided PCI With Single-Antiplatelet Therapy

      Rationale: Dual antiplatelet therapy (DAPT), consisting of aspirin and a P2Y12-inhibitor, reduces the risk of stent thrombosis, myocardial infarction and stroke after coronary stent implantation. Inevitably, it is also associated with a higher risk of (major) bleeding. Given the advances in stent properties, stenting implantation technique and pharmacology, it may be possible to treat patients with a single antiplatelet strategy using a potent P2Y12- inhibitor such as prasugrel. Objective: This study will serve as a pilot to investigate the feasibility and safety of a single antiplatelet strategy with prasugrel prior to, during and after stent implantation in 75 patients with ...

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    9. Asclepix Therapeutics partners with Notal Vision on Home OCT remote monitoring in DME and AMD clinical trials

      Asclepix Therapeutics partners with Notal Vision on Home OCT remote monitoring in DME and AMD clinical trials

      Notal Vision, Inc. announced today that the company will provide AsclepiX Therapeutics with Home OCT monitoring services through its Notal Vision Diagnostic Clinic to support AsclepiX’s AXT107 phase 1 clinical trial program. The exploratory application of the investigational home monitoring platform will add new valueable data points between the regulary scheduled study office visits. Study subjects with diabetic macular edema (DME) and wet age-related macular degeneration (AMD), who participate in the CONGO and SHASTA study sponsored by AsclepiX Therapeutics, will perform sequential daily self-imaging of their eyes with the user-friendly, self-operated Notal Home OCT device in their homes. The ...

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      Mentions: FDA Notal Vision
    10. Imaging-Guided Vessel Sizing in the Tibial Arteries

      Imaging-Guided Vessel Sizing in the Tibial Arteries

      This study aims to investigate the utilization of intravascular imaging in treatment of tibial vessels in peripheral artery disease and critical limb ischemia (CLI). The primary goal is to compare optical coherence tomography (OCT) with traditional digital subtraction angiography (DSA) in determining best treatment strategy and vessel optimization, in an effort to improve long term patency and successful wound healing in CLI. Secondary comparison with intravascular ultrasound (IVUS) is undertaken when clinically feasible. The hypothesis is that the adjunctive use of intravascular imaging will affect vessel sizing and anticipated treatment modalities, and therein affect the long term primary patency rates.

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    11. Optical Coherence Tomography Guided Laser Treatment of Basal Cell Carcinoma

      Optical Coherence Tomography Guided Laser Treatment of Basal Cell Carcinoma

      The purpose of this pilot study is to examine the treatment basal cell carcinoma (BCC) with laser technology under the guidance of optical coherence tomography imaging (OCT). The laser modality that we plan to use is the long-pulse Nd:YAG 1064nm laser, which is a non-ablative laser already shown to effectively treat BCC. Laser treatment of BCC has limited precedent in the literature, but the addition of OCT has the opportunity to enhance outcomes by better targeting the treatment and permitting more precise monitoring of clearance. We propose to use OCT imaging to guide the laser treatment to achieve optimal ...

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      Mentions: UC Irvine
    12. A Study of Noninvasive Methods to Evaluate Skin and Mucosal Conditions

      A Study of Noninvasive Methods to Evaluate Skin and Mucosal Conditions

      The purpose of this study is to find out whether using noninvasive methods to study the appearance of lesions can improve diagnostic accuracy before a biopsy is required and help guide treatment planning. The database created to store these images is called an Image Repository, and it will be used to support clinical practice, teaching and training, and future research.

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    13. Continuous Monitoring and Management of Vaginal Health Via Multifunctional OCT/OCTA/OCE Endoscopy

      Continuous Monitoring and Management of Vaginal Health Via Multifunctional OCT/OCTA/OCE Endoscopy

      We have recently developed and optimized a vaginal Optical Coherence tomography /angiography endoscopy imaging system. This technology is able to obtain a comprehensive image of the vaginal epithelium, blood vessels, and lamina propria. The primary focus of this study is establishing the Optical Coherence Tomography system's capability of capturing vaginal changes that occur before and after menopause, as well as before and after treatment with fractional-CO2 laser therapy.

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      Mentions: UC Irvine
    14. Clinical Development of Deep Learning for the TOMi Scope

      Clinical Development of Deep Learning for the TOMi Scope

      The objective of this study is to clinically develop and evaluate a machine learning approach to improve the performance and data interpretation of the PhotoniCare TOMi Scope in pediatric patients presenting at the primary care office for suspected ear infections. In this observational study, results of TOMi Scope imaging will not affect patient standard of care.

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      Mentions: PhotoniCare
    15. Physiology and Structure of the Small Airways in Patients With Chronic Airflow Obstruction or COVID-19

      Physiology and Structure of the Small Airways in Patients With Chronic Airflow Obstruction or COVID-19

      The purpose of this research project is to study small airways physiological function in patients with chronic obstructive lung disease or COVID-19 and explore the relationship with in-vivo microanatomical small airway structure as measured by OCT. Correlating endobronchial assessment with multiple breath nitrogen washout and impulse oscillometry will allow the characterisation of the relationship between small airway structural findings and these validated investigations. A small volume lung wash, endobronchial brushings and the collection of a limited number of endobronchial cryobiopsy samples will be performed to better understand the endobronchial environment of the small airways through inflammatory studies. Following the completion ...

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    16. Effect of Evolocumab on Coronary Plaque Characteristics

      Effect of Evolocumab on Coronary Plaque Characteristics

      The aim of the study is to assess the effect of evolocumab on coronary plaque morphology using intravascular imaging and gene expression analysis of peripheral blood mononuclear cells (PBMC) in patients with stable CAD on maximally tolerated statin therapy. The study combines multi-modality intravascular imaging approaches and transcriptomic based machine learning algorithms to uncover molecular mechanisms responsible for the beneficial changes in atherosclerotic lesions of patients treated with evolocumab. The primary end-points are the changes from baseline to follow-up in (1) the minimal fibrous cap thickness (FCT) assessed by optical coherence tomography (OCT) and (2) maxLCBI4mm assessed by near-infrared spectroscopy ...

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    17. Plaque Erosion Prospective Study ii

      Plaque Erosion Prospective Study ii

      Plaque erosion is associated with myocardial infarction (MI) in about 30% of cases and may require a different management approach to plaque rupture. The investigators hypothesise that plaque erosion leads to higher levels of apoptotic circulating endothelial cells (CECs) compared to plaque rupture. Aims: To compare associations between plaque erosion and plaque rupture with numbers and types of apoptotic CECs in patients with non-ST elevation MI (NSTEMI) and stable coronary artery disease controls (CAD). Additional aims are to explore signals of cellular stress (mitochondrial dsDNA), sub-populations of activated neutrophils, circulating endothelial progenitor cells and erosion-specific plasma biomarkers. Methods: Prospective observational ...

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    18. Influence of Calcium Pattern on Plaque Modification Achieved With Intracoronary Lithotripsy

      Influence of Calcium Pattern on Plaque Modification Achieved With Intracoronary Lithotripsy

      Calcified coronary artery disease is a frequently encountered problem that can lead to poorer outcomes for patients undergoing PCI. Recently, intravascular lithotripsy has become available for the treatment of callcified coronary artery disease. The effect of intravascular lithotripsy on varying calcium patterns has not been adequately explored. This is an investigator initiated, open label, non-blinded, observational study involving a number of centers in Spain examining the effect of intravasuclar lithotripsy in varying calcium patterns. 100 patients wll be enrolled. Optical coherence tomography will be used to assess the effect of intravascular lithotripsy on varying calcium patterns (concentric, eccentric and nodular).

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    19. Deep Learning on 3D Cellular-resolution Tomogram

      Deep Learning on 3D Cellular-resolution Tomogram

      Skin biopsy is the main method to diagnose skin tumors, skin inflammation, and pigmented diseases. However, biopsy is an invasive method that can cause wounds and scars. Optical coherent tomography (OCT) technology is a fast, non-invasive, non-radioactive, and label-free imaging method. This technology generates real-time images of living tissue by detecting the variations in the refractive indexes of various components in soft tissues. Recently, there is a breakthrough progress that the newly designed ultrahigh resolution OCT can provide in vivo cellular resolution similar to histopathological sections in the high magnification. In our previous clinical trial "Early feasibility study: application of ...

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    1-24 of 518 1 2 3 4 ... 20 21 22 »
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