Research studies involving people are called clinical trials. Clinical trials allow advances in medicine and identify new treatments for patients. Clinical studies provide patients access to innovative and cutting-edge technology. The Institutional Review board (IRB) oversees the site where the clinical research is conducted, reviews the ethics and safety of each study, and protects the rights and welfare of those who take part in clinical trials. As a participant in a clinical trial, you will have access to the Institutional Review board that is overseeing the research study and the physician and staff conducting the trial. The FDA supervises all aspects of the clinical research trials. Once the study is completed at all sites, all of the data is submitted to the FDA for approval.
As a patient at Orion Medical, you may be asked if you’d like to participate in a research study. A member of our Research Team will review the study with you, including any medical procedures to be conducted, frequency of study visits, and any potential risks and benefits of participating in the study. Research personnel will answer all your questions before you decide whether to volunteer to be part of the study. Each clinical trial is different and has very specific entrance guidelines. To be eligible to participate in a study, you must meet the criteria specified by the study protocol. Talk to your doctor, or ask to speak with a Research Coordinator about volunteering to participate in clinical trial.
Informed consent is an ongoing process to help you understand what is involved in taking part in a research study. As such, the research team will explain the following items to you :
- The purposes and description of the study
- The test, treatments, and procedures to be performed, including any that are experimental (new and not fully tested)
- How long the study will last
- Possible benefits and risks
- Other treatments and options
- How your privacy will be protected
- Who to contact for answers to your questions
- That taking part in a study is strictly your choice
VenaSeal Spectrum Study :
- Medtronic VenaSeal Spectrum: Global, Post-Market Prospective, Multi-Center, Randomized Controlled Trial of the VenaSeal™ Closure System vs. Surgical Stripping or Endothermal Ablation (ETA) for the Treatment of Early and Advanced Stage Superficial Venous Disease. The study is designed to evaluate the subject’s experience and clinical improvement after treatment with the VenaSeal™ system compared to Standard of Care treatments such as surgical stripping or endothermal ablation in the treatment of symptomatic superficial venous disease. In the venous ulcer leg study, the study will also collect specific information on wound healing from subjects with an active venous leg ulcer.
- Endothermal ablation is a minimally invasive treatment that involves the insertion of a thin, flexible tube called a catheter into a diseased vein and uses heat to seal it shut. Blood that would normally return toward the heart through these veins will then travel through other veins instead. Over time the treated vein shrinks and is absorbed by the body. Compared with surgical options like vein stripping, endovenous thermal ablation results in less pain and quicker average recovery time.
- VenaSeal™ is a medical adhesive designed for closure of diseased veins in the legs. Vein disease Or varicose veins can cause symptoms such as heaviness, aching or throbbing pain in legs, cramps, restless leg syndrome, itchiness, fatigue, swelling and tenderness along the vein, and sometimes wounds or venous ulcers. (Medtronic Vascular INC).
Insertable Cardiac Monitor System Clinical Study :
- LUX-Dx Heart Failure Sensors in an Insertable Cardiac Monitor System Clinical Study. The primary objective of this study is to collect sensor and heart failure (HF) event data that will be used to develop and test new diagnostic features for the insertable Boston Scientific cardiac monitor (ICM) systems.
Prospective Evaluation Of Open Irrigated Ablation Catheters Study :
- Prospective evaluation of open irrigated ablation catheters with high resolution mapping to treat paroxysmal atrial fibrillation. To obtain data for the Rhythmia™ Mapping System in conjunction with Boston Scientific Open-Irrigated (OI) Catheters for ablation of Paroxysmal Atrial Fibrillation (PAF) according to current international and local guidelines. Primary objective: To assess acute and long-term outcomes for the Rhythmia Mapping System in conjunction with Boston Scientific Open-Irrigated Ablation Catheters to treat de novo Paroxysmal Atrial Fibrillation. De Novo PAF is defined as subjects undergoing first ablation procedure for PAF with no prior left atrial ablation (RF, Cryo, Surgical).
NEwTON AF Study:
- Study: Clinical Evaluation of the StablePoint Catheter and Force-Sensing System for Paroxysmal Atrial Fibrillation (NEwTON AF).
- Study objective: To demonstrate the safety and effectiveness of the IntellaNav StablePoint Catheter and Force Sensing System with DIRECTSENSE for treatment of drug refractory, recurrent, symptomatic Paroxysmal Atrial Fibrillation (PAF).
- Device Information: The IntellaNav StablePoint™ Catheters are thin tubes that are placed inside your heart during the ablation procedure. The tubes are used to apply heat to the heart muscle in areas known to cause atrial fibrillation. The heat causes tiny scars which can help stop the atrial fibrillation.
The IntellaNav StablePoint™ Catheter and Force-Sensing System™ are considered “investigational” in the United States because they are not approved by the Food and Drug Administration (FDA) for the treatment of atrial fibrillation.
The Force-Sensing System™ is a combination of many different parts, which you can see in the picture below. In basic terms, the IntellaNav StablePoint™ Catheter is used with a computer that helps guide your doctor during the ablation procedure, which includes the force being applied by the catheter. The computer is called the Rhythmia HDx™ Mapping System and is used to collect information about the shape and the electrical activity of your heart. The information collected helps your doctor perform the ablation procedure.
- Precision Event Monitoring of Patients with Heart Failure using HeartLogic™ (PREEMPT-HF). HeartLogic technology is a function of some Boston Scientific implanted cardiac defibrillators with several sensors with a 70% sensitivity of detecting worsening of heart failure approximately 34 days in advance (Boston Scientific).
- Phase 3, double-blind, placebo-controlled, randomized withdrawal study with open-label extension, to assess the efficacy and safety of rilonacept treatment in subjects with recurrent pericarditis – Rilonacept inhibition of interleukin-1 alpha and beta for recurrent pericarditis. This study is being done to learn if a medicine called rilonacept is an effective and safe treatment for recurrent pericarditis. Pericarditis is the inflammation of the fibrous sac surrounding the heart (Kiniska).
- A Phase 3, Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Obeticholic Acid in Subjects with Compensated Cirrhosis due to Nonalcoholic Steatohepatitis (Intercept Pharmaceuticals).
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Study to Evaluate the Efficacy and Safety of Elafibranor in Patients with Nonalcoholic Steatohepatitis (NASH) and fibrosis (Genfit).
- A Phase 3, Double-Blind, Randomized, Long-Term, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of Obeticholic Acid in Subjects with Nonalcoholic Steatohepatitis (Intercept Pharmaceuticals).
- AURORA: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Cenicriviroc for the Treatment of Liver Fibrosis in Adult Subjects with Nonalcoholic Steatohepatitis (Tobira).
- A Multicenter, Double-blind, Placebo-controlled, Randomized Withdrawal, Parallel Group Study of Patiromer for the Management of Hyperkalemia in Subjects Receiving Renin-Angiotensin-Aldosterone System Inhibitor (RAASi) Medications for the Treatment of Heart Failure (DIAMOND).
- Hyperkalemia is dangerously high potassium levels in the blood. The main purpose of this study is to learn if taking Patiromer (oral research study drug) may help subjects continue taking heart failure medications without developing high potassium, and therefore help with fewer hospitalizations and increased life expectancy (Relypsa, Inc).
Cardio Flow FreedomFlow™ Study:
- Evaluation of the Cardio Flow FreedomFlow™ Orbital
Circumferential Atherectomy System to Treat Peripheral Artery Disease (PAD). The purpose of this study is to evaluate the safety and effectiveness of Cardio Flow FreedomFlowTM Orbital Circumferential Atherectomy System to treat PAD for atherosclerotic plaque and to target lesions in the peripheral vasculature of the low extremities (Cardio Flow, INC).
- PAD is a circulation disorder that causes the blood vessels in the legs to narrow, block, or spasm. Typical PAD symptoms can include pain and fatigue in legs, especially during exercise or walking.
- Testosterone replacement therapy for assessment of long-term vascular events and efficacy response in hypogonadal men with increased risk for cardiovascular disease (Abbvie). Hypogonadism is also known as testosterone deficiency. This study population is men 45 to 80 years of age with low serum testosterone concentrations who exhibit hypogonadal symptoms and have evidence of cardiovascular (CV) disease or are at an increased risk for CV disease and who have not been treated with testosterone in the past six months.