Clinical Trials About "QUANTM Irradiation System Earns Mark Approval" RSS

04:53 EDT 22nd March 2019 | BioPortfolio

We list hundreds of Clinical Trials about "QUANTM Irradiation System Earns Mark Approval" on BioPortfolio. We draw our references from global clinical trials data listed on and refresh our database daily.

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Showing "QUANTM Irradiation System Earns Mark Approval" Clinical Trials 1–25 of 11,000+


User Evaluation Study of SyncVision System With Software v4.X

This is a prospective, single-arm, unblinded, case observation study evaluating a pre-release 'Conformité Européenne' (CE)-mark co-registration software system along-side of a commercially- released CE-mark coronary physiology and X-ray system during routine clinical workflow. The purpose of this study is to collect Professional user feedback regarding clinical utility of the SyncVision 4.X system.

Cross Over Convenience And Preference Study Of New Mark VII Compared To Genotropin Pen In Pediatric And Adult Subjects

Convenience and preference for the new Mark VII pen compared to the current Genotropin pen will be assessed using a questionaire. it is expected that the new pen will be preferred or at least no different to the current pen.

New Enrollment Post-Approval Study of the Argus® II Retinal Prosthesis System

This post-approval study is being implemented to monitor the use of Argus II System in a larger US population than available within pre-approval studies. An attempt will be made to include all eligible and willing subjects implanted with Argus II System in the United States. Safety data will be monitored to ensure continued acceptability of risks to study subjects. The utility (i.e. visual function and functional vision) and reliability of Argus II System will also be e...

Contour Neurovascular System - European Pre-Market Unruptured Aneurysm

Cerus Endovascular is sponsoring a prospective, multi-center trial to document the safety and performance of the Contour Neurovascular System™ ("Contour"). The purpose of the study is to document safety and performance of the Contour in treatment for patients with intracranial aneurysms (IA). The data from the study will be reported as a Pre-Market study to the Notified Body to support CE Mark approval.

Evaluation of the Contribution of Transoral Robotic-assisted Surgery Using Da Vinci Xi for Head and Neck Tumors

Head and Neck cancers are treated either with surgical resection followed by adjuvant radiotherapy, or with organ preservation strategies using definitive radiotherapy with or without concomitant chemotherapy. These treatments have long-time functional side effects and consequences on the quality of life. Transoral robotic surgery has been developing since 2006 by Weinstein and O'Malley in alternative to open surgery, to decrease the morbidity of the large surgical approach. T...

ACURATE Neo™ AS Aortic Bioprosthesis for Implantation Using the ACURATE neoTM AS TF Transfemoral Delivery System in Patients With Severe Aortic Stenosis

Cinical trial aimed at evaluating the safety and performance of the ACURATE neo™ AS Aortic Bioprosthesis and ACURATE neo™ AS TF Transfemoral Delivery System for CE mark approval purposes.

Performance, Safety and Efficacy of PICO Device.

The study is being conducted to evaluate the safe and effective use of the PICO 7 system in surgically closed incision sites and wounds requiring closure by skin graft or flap as part of the PMCF plan for this product, for the purpose of continuing CE (Conformité Européene) Mark approval in accordance with MEDDEV 2.12-2

FlexNav EU CE Mark Study

The purpose of this clinical investigation is to characterize the safety of the second-generation FlexNav™ Delivery System for transfemoral implantation of the Portico™ Transcatheter Aortic Heart Valve in symptomatic severe aortic stenosis patients who are considered of high or extreme risk for surgical aortic valve replacement. Data from the study will be used to support CE Mark of the FlexNav™ Delivery System and Loading System in Europe.

Post PMA-Approval Study: New Enrollment Post PMA-Approval Study Post-approval Study Group (New Enrollment)

The primary objective of this study is to evaluate the performance of the Cormet Hip Resurfacing implant system in the post-approval environment.

Implantable System for Remodulin Post-Approval Study

The purpose of the Implantable System for Remodulin (ISR) Post Approval Study (PAS) is to provide evaluation and periodic reporting of the safety and effectiveness of Medtronic market-released ISR, including the catheter and the pump.

HeartMate 3 CE Mark Study Long Term Follow-up

The purpose of this clinical investigation is to report the long term survival and incidence of adverse events in the patients who were implanted with HM3 in the CE Mark Study and continue to be ongoing with the HeartMate 3 LVAS after the CE Mark Study 2 year follow-up. The study will be a single arm, prospective, multi-center, non-blinded and non-randomized study, intended to report on the long term use of the HeartMate 3 LVAS in those patients that completed the 2-year follo...

Whole Brain Irradiation in Primary Central Nervous System (CNS) Lymphoma (PCNSL)

The aim of the study is to deliver primary systemic high-dose methotrexate (MTX) treatment to PCNSL patients and to define the role of whole brain irradiation (WBI) in primary therapy, i.e., to analyze whether patients who have undergone primary chemotherapy can postpone irradiation with its possible late sequelae until recurrence without incurring losses in progression-free and overall survival. This is studied here for the first time worldwide in a systematic, controlled and...

Balanced Knee System Clinical Protocol for IRB Approval

The protocol will define the clinical study for Ortho Development's Balanced Knee® System (BKS) for subsequent review and approval by an Institutional Review Board (IRB).This clinical study will compare the clinical outcomes of BKS to currently marketed devices.

Post Approval Study of the Commercially Available U-Motion II+ Acetabular System and UTF Reduced Stem

This is a prospective, single arm, multi-center, post-approval study designed to evaluate the short and long term clinical performance and safety in subjects receiving primary total hip arthroplasty (THA) with the U-Motion II+ Acetabular System and UTF Reduced Stem.

A Post-Approval, Single-Arm Study of the SYNERGY Stent System in China

A prospective, observational, single-arm, open-label, multicenter, post-approval study. To compile real-world clinical outcomes data for the SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGYTM Stent System) in real-world clinical practice in China.

German Multicenter Trial for the Treatment of Newly Diagnosed T-Lymphoblastic Lymphoma in Adults

This study evaluates the efficacy and tolerability of treatment for T-lymphoblastic lymphoma (T-LBL) according to a protocol for acute lymphoblastic leukemia. Patients receive one year of intensive cyclical chemotherapy with additional prophylaxis for central nervous system (CNS) relapse by intrathecal therapy and cranial irradiation and mediastinal irradiation after induction chemotherapy.

Navigator 1.5 Accuracy Study

The purpose of the study is to confirm that the accuracy and safety of Version 1.5 of the FreeStyle Navigator Continuous Glucose Monitoring System are not impacted by the updates to the system algorithm and minor changes to the user interface and sensor delivery unit, such as adhesive sterilization method. It is anticipated that information collected will be submitted as a supplement to Premarket Approval Application (P050020) to the US Food and Drug Administration for approva...

Total Temporomandibular Joint Replacement System Post Approval Study

Post-Approval Study (PMA CoA) in Order to Obtain Additional Long Term Safety and Effectiveness Data

CardioMEMS HF System OUS Post Approval Study

The purpose of this Post Approval Study (PAS) is to evaluate the use of the CardioMEMS HF System in patients with Class III Heart Failure in a commercial setting.

Destination Therapy Post Approval Study

Medtronic is sponsoring the HeartWare™ HVAD™ Destination Therapy (DT) Post Approval Study (PAS) to further confirm safety and effectiveness of the HeartWare Ventricular Assist Device System (HVAD System) when used as intended, in "real-world" clinical practice. The Destination Therapy Post Approval Study (DT PAS) is conducted within Medtronic's Product Surveillance Platform.

Mechanical Muscle Activity With Real-time Kinematics (M-MARK): A Novel Combination of Existing Technologies to Improve Arm Recovery Following Stroke

About 150,000 people in the UK suffer a stroke each year and ~60% with moderate to severe stroke fail to recover arm or hand use. Stroke rehabilitation is increasingly home-based following early supported discharge (ESD) from hospital to facilitate self-management and avoid problems associated with prolonged hospital stays. There is strong evidence that intensive practice and re-education of normal movement is essential for functional motor recovery, hence the NHS guideline of ...

Obalon Post-Approval Study

The Obalon Balloon System - Post-Approval Study is a prospective, observational, and multi-center study.

Performance of EOS Imaging System in the Assessment of Spondyloarthritis Structural Changes Compared With Standard Radiography

Spondyloarthritis is a chronic rheumatic disease that requires prolonged radiographic follow-up. This repetitive exposure to ionizing radiation puts at risk the radiosensitive organs exposed in the field of irradiation. A new low-dose imaging system has emerged. This technique, called EOS, offers the advantage of lower irradiation associated with high images quality. Our goal through this work was to evaluate the reliability of the EOS imaging system compared to conventional ra...

TARGET Post-Approval Study

The purpose of this prospective, multicenter, single arm, observational post-approval study is to demonstrate continued safety of the Axium Neurostimulator System for dorsal root ganglion (DRG) stimulation. The primary endpoint is the 12-month serious adverse event rate for permanent implants.

Total Body Irradiation +/- Total Lymphoid Irradiation & Anti-Thymocyte Globulin in Non-myeloablative Hematopoietic Cell Transplantation

The purpose of this study is to evaluate whether addition of a low dose of total body irradiation (TBI) to a standard preparation for transplant [total lymphoid irradiation (TLI) and anti-thymocyte globulin (ATG)] conditioning will help to augment donor chimerism without reducing tolerability of this regimen or increasing the risk of graft-vs-host disease (GVHD)

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