Articles in category: Clinical Trials

1. Avinger Enrolls First 50 Patients in INSIGHT Clinical Trial

   Explore Optical Coherence Tomography News Jul 11 2019 Cardiology , Clinical Trials , Other Business News

   

   Avinger, Inc. (NASDAQ: AVGR), a commercial-stage medical device company marketing the first-ever image-guided, catheter-based system for diagnosis and treatment of Peripheral Artery Disease (PAD), today announced the 50 th patient enrolled in its INSIGHT clinical trial. The INSIGHT trial is a prospective, global, single arm, multi-center study to evaluate the safety and effectiveness of the Pantheris ® Lumivascular atherectomy system for treating in-stent restenosis (ISR) in lower extremity arteries. Dr. Jaafer Golzar, Avinger’s Chief Medical Officer and a highly experienced interventionalist, noted, “We are pleased to have the first 50 cases completed as part of our INSIGHT IDE study. Early ...

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   Mentions: Avinger

2. Severely Calcified Coronary Lesions Prepared With Rotational Atherectomy and Modified Balloons

   Explore Home - ClinicalTrials.gov Jul 10 2019 Cardiology , Clinical Trials

   

   A prospective single-arm trial to evaluate the acute and long term efficacy of a combined strategy of lesion preparation with rotational atherectomy followed by cutting balloon and by hybrid sirolimus-eluting stent implantation in an angiographically well-defined group of patients with severely calcified coronary lesions.

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3. 2nd International Survey on Interventional Strategies

   Explore Home - ClinicalTrials.gov Jun 28 2019 Cardiology , Clinical Trials

   

   The study aims to evaluate the decision-making pathways of interventional cardiologists, when assessing patients, presented with stable coronary artery disease.

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4. Physiology & Optical Coherence in STEMI

   Explore Home - ClinicalTrials.gov Jun 20 2019 Cardiology , Clinical Trials

   

   The objective of this study is to prospectively evaluate the outcomes of different treatment pathways using a Physiology & Imaging guided PCI in patients with STMEI. A multi-centre study that will prospectively enrol consecutive STEMI patients who don't receive primary PCI within 48 hours after symptom onset because of different reasons. STEMI patients with culprit lesion stenosis between 0%-90% will be included in this study and randomized to angiography-guided, FFR-guided or OCT guided PCI groups.

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5. NOTAL-OCT V.2.5 vs Commercial OCT in AMD Patients

   Explore Home - ClinicalTrials.gov May 31 2019 Ophthalmology , Clinical Trials

   

   Primary objective: To evaluate the level of agreement between the NOTAL-OCT V2.5 and a commercial OCT in the presence of fluid as identified in the OCT images, in the central 10 degrees of the macula in AMD (Age-related Macular Degeneration) patients. Secondary objectives: To evaluate the level of agreement between the NOTAL-OCT V2.5 and a commercial OCT in the presence of fluid as identified in the OCT images, in the central 10 degrees of the macula in DME (Diabetic Macular Edema) patients. To evaluate patient experience when self-operating the Notal-OCT V2.5.

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   Mentions: Notal Vision

6. Optical Coherence Tomography and Optic Neuritis Not Related to Multiple Sclerosis

   Explore Home - ClinicalTrials.gov May 24 2019 Neurology , Ophthalmology , Clinical Trials

   

   The visual prognosis of optic neuritis not related to multiple sclerosis is unknown, both in terms of functional recovery and evolution. This prospective cohort study aim to assess the ophthalmological evolution of patients presenting an episode of optic neuritis (NO) not related to a multiple sclerosis or to a clinically isolated syndrome.

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7. Analysis of the Variation in Thickness of Per-papillary Retinal Optic Nerve Fibres in Professional Rugby Players

   Explore Home - ClinicalTrials.gov May 21 2019 Neurology , Ophthalmology , Clinical Trials

   

   The main hypothesis is that exposure to repeated shocks is associated with a greater decrease in the thickness of optical nerve fibres. In order to show a association between the occurrence of concussions (in number and severity) and the variation in the thickness of the retinal nerve fibre layer, all participating rugby players will have an ophthalmologic examination (OCT and (retinophotography) at the beginning and end of the Rugby season.

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8. Apelin as a Potential Treatment for Chronic Kidney Disease

   Explore Home - ClinicalTrials.gov May 20 2019 Urology , Clinical Trials

   

   Chronic kidney disease (CKD) affects 8-16% of the world's population, and is independently associated with cardiovascular disease (CVD). As renal function declines, rates of major adverse cardiovascular events, cardiovascular and all-cause mortality increase. In addition to hypertension, increased arterial stiffness is characteristic of CKD, a marker of CVD risk, and an independent predictor of mortality in CKD patients. The endothelium is an important regulator of arterial stiffness, and endothelial dysfunction is a feature of CKD and a predictor of CVD. Current treatment of CKD is limited and aims to reduce blood pressure and proteinuria through the use of angiotensin ...

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9. Role of Intracoronary Imaging in Plaque Identification

   Explore Home - ClinicalTrials.gov May 16 2019 Cardiology , Clinical Trials

   

   NSTE-ACS patients are more likely to exhibit high-risk plaque characteristics in non-culprit lesions. Both IVUS and OCT imaging techniques interact in a complementary manner to provide morphological characterization of the atherosclerotic coronary plaques and help identification of high-risk vulnerable plaques. Using morphological parameters obtained from OCT and IVUS, a new plaque vulnerability score will be established for more precise definition of the most vulnerable plaques that carry the greatest risk of rupture and subsequent detrimental clinical outcomes in the future. Such score might help in targeting these plaques with certain therapeutic interventions aiming to their stabilization.

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   Mentions: Boston Scientific St. Jude Medical

10. Optical Coherence Tomography Angiography (OCT-A) and Central Serous Chorioretinopathy (CSC) (OPACITY)

    Explore Home - ClinicalTrials.gov May 15 2019 Ophthalmology , Clinical Trials

    

    Optical Coherence Tomography Angiography (OCT-A) is a noninvasive imaging technique that allows one to see blood vessels in the retina. The investigating team used this approach in patients with acute, recurrent and persistent subtypes of Central Serous Chorioretinopathy (CSC) to check for possible Choriocapillaris hypoperfusion. The presence or absence of these microvascular changes was explored in both eyes of the patients and compared to a control group of healthy volunteers. The possibility of a correlation between Choriocapillaris flow deficits, age and spontaneous resolution of serous retinal detachment was also evaluated. This study was conducted in an effort to improve one ...

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11. Infracyanine Green vs Brilliant Blue G in Macular Hole Inverted Flap Surgery: A Swept Source OCT Analysis.

    Explore Home - ClinicalTrials.gov May 10 2019 Ophthalmology , Clinical Trials

    

    This study will compare by swept-source optical coherence tomography (SS-OCT) the retinal morphology after inverted internal limiting membrane (I-ILM) flap vitreoretinal surgery for medium-to-large macular holes using infracyanine green (IFCG) vs brilliant blue G (BBG) dyeing. It is a single-center prospective, randomized study. One group of patients will undergo I-ILM vitrectomy with IFCG staining, the other vitrectomy with BBG staining. Postoperative six-month corrected distance visual acuity, macular hole closure rate, and SS-OCT parameters will be compared and statistically analyzed. The aim of the study is to verify if these parameters can be negatively affected by toxicity related to the use ...

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    Mentions: Azienda Ospedaliera San Paolo

12. NinePoint Medical Announces Publication of 1000 Patient Registry Study

    Explore Optical Coherence Tomography News May 9 2019 Gastroenterology , Other Non-Medical , Clinical Trials

    

    NinePoint Medical, Inc, a transformative medical device company pioneering the use of Optical Coherence Tomography (OCT) for gastrointestinal applications, today announced the publication of their 1000 patient Volumetric Laser Endomicroscopy (VLE) Registry study focused on Barrett’s Esophagus. The 18 site study, published in Diseases of the Esophagus , enrolled 1000 patients between 2014 and 2016 for imaging using the NvisionVLE® Imaging System. The study was designed to determine usage patterns of VLE in clinical practice and to estimate quantitative and qualitative performance metrics, with this publication focused on Barrett’s Esophagus. All enrolled patients were examined with standard upper endoscopy ...

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    Mentions: FDA NinePoint Medical Eman Namati

13. OCT Explores Vascular Response and Healing Profile After Stenting in CTO

    Explore Home - ClinicalTrials.gov May 6 2019 Cardiology , Clinical Trials

    

    True-false-true occurred during wire penetration in coronary CTO procedure. Subintimal stenting influences vascular response. Intravenous ultrasound confirmed wire position in the procedure. Then stenting procedure was performed. Optical coherence tomography was used for exploring long-term vascular response and healing profile after successful coronary stenting in CTO lesions.

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    Mentions: Fudan University

14. OCTA (Optical Coherence Angiography Tomography) Versus Structural OCT(Optical Coherence Tomography) in Neovascular AMD (Age Macular Degeneration)

    Explore Home - ClinicalTrials.gov May 6 2019 Ophthalmology , Clinical Trials

    

    The objective is to find if there is a relationship between the Fractal Dimension, the gap, vascular density (VD), the surface, the span ratio and the status of the choroidal neovessels to adjust the interval between 2 intravitreal injections nor on the qualitative aspect of Optical Coherence Structural Tomography but also on quantified quantitative and objective values.

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    Mentions: Centre Hospitalier Intercommunal de Créteil Eric H. Souied

15. PhotoniCare Inc. Announces Initiation of a Multi-Site Registered Clinical Study in Patients Undergoing Surgery for Chronic Middle Ear Infection

    Explore Optical Coherence Tomography News May 1 2019 Otolaryngology , Clinical Trials , Other Business News

    

    PhotoniCare Inc., a medical device company headquartered in Champaign, Illinois, announces successful initiation of a multi-site registered clinical study to evaluate the imaging capabilities and image analysis performance of the PhotoniCare TOMi Scope. Children’s National Health System (Washington, D.C.) is the first initiated of two clinical sites involved in this registered multi-site clinical study, along with Carle Foundation Hospital (Urbana, Illinois). The study is led by Dr. Diego Preciado, Children’s National, and Dr. Ryan Porter, Carle Hospital, along with a team of recognized otitis media experts at both clinical sites. This multi-center study plans to enroll a ...

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    Mentions: National Institutes of Health University of Illinois at Urbana-Champaign PhotoniCare

16. Surgical Outcome of Macular Membrane Peeling Associated With Significant Macular Drusen

    Explore Home - ClinicalTrials.gov Apr 25 2019 Ophthalmology , Clinical Trials

    

    Surgical outcome of patients with macular drusen and co-existing abnormalities of the vitreoretinal interface, who routinely undergo pars plana vitrectomy with membrane peeling, is evaluated. Best corrected visual acuity as well as optical coherence tomography data are compared at baseline and last follow up. The rate of development of choroidal neovascularization postoperatively is noted.

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17. WF and Pr OCTA in Diabetic Retinopathy

    Explore Home - ClinicalTrials.gov Apr 22 2019 Ophthalmology , Clinical Trials

    

    Diabetic retinopathy (DR) is a leading cause of vision loss in working-age Americans. Capillary damage from hyperglycemia causes vision loss through downstream effects, such as retinal ischemia, edema, and neovascularization (NV). Proper screening and timely treatment with laser photocoagulation and anti-vascular endothelial growth factor (VEGF) injections can minimize morbidity. In the last decade, clinicians have been able to use objective structural data from optical coherence tomography (OCT) to guide the treatment of diabetic macular edema. Other aspects of care, however, still largely depend on subjective interpretation of clinical features and fluorescein angiography (FA) to determine the disease severity and treatment ...

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    Mentions: Oregon Health & Science University

18. Monitoring Large Vessel Vasculitis With PET/MR Imaging

    Explore Home - ClinicalTrials.gov Apr 15 2019 Cardiology , Ophthalmology , Clinical Trials

    

    Large vessel vasculitis (LVV) causes blood vessel inflammation leading to pain, fatigue and complications such as aneurysm formation and stroke. Treatments used can have significant side-effects. Doctors find it difficult to determine when to start and stop treatment, often leading to over- or under-treatment. A new test is required to determine disease activity that will guide treatment more accurately. This study will recruit participants with active LVV from throughout Scotland in order to assess the ability of two new types of scan - positron emission tomography with magnetic resonance imaging (PET/MR) and retinal optical coherence tomography (OCT) - to determine disease ...

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19. Defining Disease Activity in Neovascular AMD With Optical Coherence Tomography Angiography

    Explore Home - ClinicalTrials.gov Apr 10 2019 Ophthalmology , Clinical Trials

    

    The purpose of this study is to be able to describe optical coherence angiography (OCTA) patterns of disease activity and quiescence in eyes that have received treatment. Our target population group is patients that have neovascular age-related macular degeneration and have had treatment with aflibercept for this condition. This is a single-site study and does not involve any masking or treatment allocation.

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20. The Heidelberg Engineering SPECTRALIS Macular Precision and Agreement Study

    Explore Home - ClinicalTrials.gov Apr 4 2019 Ophthalmology , Clinical Trials

    

    This is a prospective clinical study that will be conducted at one clinical site located in the United States to assess two grids.

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    Mentions: Heidelberg Engineering

21. Optical Coherence Tomography of Nerve Fiber Layer and Ganglion Cell Complex After Cataract Extraction

    Explore Home - ClinicalTrials.gov Mar 26 2019 Ophthalmology , Clinical Trials

    

    The investigator's study includes two groups of patients, each consists of 25 eyes, group 1 (cataract group)includes patients who are planned for cataract extraction without any other preexisting retinal or optic nerve pathology that may affect the RNFL thickness, while group 2 (combined cataract and glaucoma group) includes patients who are diagnosed with POAG controlled on medical treatment with cataract and planned for cataract extraction only. The OCT scans with complete ophthalmological examination are done before surgery and 6 weeks after uneventful cataract extraction (phacoemulsification with intraocular lens implantation

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22. Objective Choroidal Thickness Measurements in Uveitis

    Explore Home - ClinicalTrials.gov Mar 26 2019 Ophthalmology , Clinical Trials

    

    Optical Coherence Tomography (OCT) machines are non-contact instruments that can provide micrometer scale imaging of biological tissue. Applying the image processing allows us to automatically measure the choroidal thickness with good interclass correlation coefficient to the manual measurements.

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23. Clinical Evaluation of the TOMi Scope

    Explore Home - ClinicalTrials.gov Mar 26 2019 Otolaryngology , Clinical Trials

    

    The objective of this study is to evaluate the imaging capabilities and image analysis performance of the PhotoniCare TOMi Scope in pediatric patients undergoing tympanostomy tube placement for otitis media. In this observational study, results of TOMi Scope imaging will not affect patient standard of care.

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    Mentions: PhotoniCare

24. The Use of Fractional Ablative CO2 Laser vs Control on Acute Traumatic Injuries to Prevent Scar Formation

    Explore Home - ClinicalTrials.gov Mar 25 2019 Dermatology , Clinical Trials

    

    Surgical standard for treating traumatic burn injury scarring is to wait one year following the initial assault prior to beginning treatment. This study investigates the use of fractional ablative CO2 laser when begun within 3 months of a traumatic burn injury and it's impact on scar formation compared to the control. We hypothesized that early intervention would substantially mitigate the formation of scar tissue and help restore more normal appearing skin.

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OCT Companies in the News

1. (1 articles) Avinger