46 Clinical Trials for Various Conditions
The goal of this clinical trial is to evaluate oxygenation in the colon in people with acquired vascular abnormalities in the proximal colon.
This is a prospective, multicenter, single arm study designed to evaluate the safety and efficacy of the Temporary Bare Spur Stent System (Spur Stent System).
This is a multi-center, multi-cohort, prospective, open-label study of VELOS for treatment of vascular skin disorders. The plan is to enroll up to 60 subjects from up to 3 centers in the US and worldwide. The purpose is to collect data from the use of VELOS.
Evaluation of the safety and efficacy of the 755nm Alex laser for the treatment of benign pigmented and vascular lesions and scars
Dermatologists have for many years treated vascular lesions by a variety of modalities including cryosurgery, electrotherapy, dermabrasion and radiation. It has been hypothesized that simultaneous delivery of these two wavelengths may provide safer, and in some cases more effective, vascular lesion removal. The Tandem laser is capable of emitting multiple cryogen spurts intermittently with multiple 532/1064 nm laser pulses.This mode may reduce malformed blood vessels with a low incidence of long-term side effects.
Multi-center, Prospective, Open-Label with Before-After Study Design. Each subject will receive a single treatment. Treatment presets will be determined by the SMART Camera system and approved by the physician. Follow-up will take place at 1 month following the treatment. Skin and lesion attributes will be examined by the SMART system and the physician
This is a study looking at a new way to evaluate vascular problems or tumors in brain surgery patients using a standard \& approved intravenous dye and augmented reality.
This is a non-randomized, multi-center, open-label, prospective clinical study evaluating the clinical treatment with Candela Medical Technology.
The intended use of the RF (radiofrequency) device used in this study is to assess the efficacy of the handpiece for the treatment of facial wrinkles. If the other device (Intense Pulsed Light) laser in this study is used, the intended use will be for the treatment of benign pigmented and/or vascular lesions.
Demonstrate the safety and efficacy of the GentleMax Pro Plus™ laser system for its intended uses: hair removal including pseudofolliculitis barbae (PFB), clearance of pigmented and/or vascular lesions, temporary increase of clear nail in patients with onychomycosis and improvement in appearance of wrinkles. Evaluate GentleMax Pro Plus™ laser system for the clearance of acne.
This is a prospective, open label, single-center clinical study to collect safety and efficacy data on the Elite iQ workstation. The intended use of the Elite iQ device used in this study is for the treatment of hair removal, pseudo folliculitis barbae, and benign vascular and pigmented lesions.
The purpose of this research is to find out if the use of topical timolol 0.5% solution applied twice daily will help to shrink rosacea lesions around the eye.
The objective of this study is to evaluate acute clinical results of orbital atherectomy (OA) via radial artery access, including complication rates and cost effectiveness.
In the US, pancreas cancer is the fifth leading cause of cancer related deaths. It was estimated to have taken 36,800 lives in 2010. Unfortunately, curing pancreatic cancer requires surgical removal. Surgical removal of the pancreas is associated with high morbidity and mortality, as well as high rates of complications. One way to aid surgeons in removing pancreatic tumors is by providing them with a good idea of where the tumor is located and what surrounding structures are involved. This currently happens through many different modalities of imaging; usually computed tomography (CT) and endoscopic ultrasound. Even with these forms of imaging (and sometimes others), surgeons will occasionally open a patient and find that the tumor cannot be removed due to its involvement with surrounding structures. One way to avoid potentially unnecessary procedures or to help a surgeon navigate this delicate procedure would be to provide more detailed information about the tumor. Several of the techniques currently used to image the body have rapidly advanced over recent years. Typical advancements come through better resolution of the images or contrast to enhance desired parts of the images. Ultrasound has not seen such a two pronged advance. Ultrasound has seen substantial advances in resolution to enhance picture quality, but contrast has not been used clinically to assess pancreatic masses whereas it is for cardiologists to use contrast to look at potential defects in the heart. The contrast that is used with ultrasound is different from that of CT scans. CT scanners use a dye that can be potentially hazardous. This dye can lead to serious kidney damage in some patients. Ultrasound contrast, on the other hand, is made of small micro bubbles filled with a harmless gas. Because of the way ultrasound works, these micro bubbles reflect the sound waves differently than the surrounding tissue and thus provide contrast between normal tissue and abnormal tissue. The contrast used in this study, Definity, and is the same contrast used by Cardiologists. The CE-EUS will be used for research purposes only and will not be used for any clinical decision making. The surgeon will be blinded to the results of the research CE-EUS. The investigators will compare the research pre-operative contrast enhanced endoscopic ultrasounds images with already completed standard-of-care CT scans, the actual pancreatic involvement seen in surgery and the pathology reports.
Proposed Study: Treatment protocol for the use of the topical Rapamycin/Sirolimus for Complicated Vascular Anomalies and other susceptible lesions 1. Aim The aim of this treatment study is to evaluate the benefit and tolerability of topical sirolimus applied to cutaneous vascular anomalies in pediatric patients. The primary end point will be individually determined based on improvement in lesional clinical characteristics over baseline 2. Rationale for topical sirolimus use in VA The rationale for the use of topical sirolimus is to minimize these potential side effects and risks. Data for the use of topical sirolimus for vascular anomalies at this time are anecdotal and case reports only. As such, this prospective protocol seeks to determine the effectiveness and tolerability of topical sirolimus on patients with vascular anomalies that have a cutaneous component. 3. Experimental design This is an open-labeled efficacy trial with the aim to determine if topical sirolimus can be safe and efficacious in treating the cutaneous component of complicated vascular anomalies. Patients who meet eligibility criteria with a diagnosis of vascular anomaly (VA) with cutaneous component will be offered treatment with the investigational topical sirolimus. Patients will receive topical sirolimus therapy for a total of six months and will be monitored regularly at the research site for clinical response. Response will be based on pre-determined clinical criteria. Patients will be removed from study if there is no response at three months after initiation of therapy. Clinical response will be defined as improvement in measurable parameters defined at the time of initiation of therapy. These include 1. Size of lesions, measured in two parallel longest diameters 2. Flattening of lesion 3. Number of vesicles 4. Episodes of superinfection or bleeding 5. Improvement in pain 4. Drug Information The topical sirolimus formulation will be made at a concentration of 1% sirolimus ointment. Bulk sirolimus powder will be compounded in a liposomal base in a GMP level pharmaceutical company. This base will enhance drug penetration into the skin. It ensures adequate adhesion to the application area and a low degree of systemic absorption. Due to limited absorption only mild side effects are expected.
The purpose of this study is to develop imaging techniques to determine the density of blood vessels and the amount of blood flow in Kaposi s sarcoma (KS) tumors. KS tumors depend on the formation of new blood vessels for their growth. Some experimental therapies for KS are directed at reducing the amount of blood vessels and blood flow in these lesions. Measurement of blood vessel density and blood flow in these lesions could be useful in evaluating the effectiveness of both standard and experimental treatments for this disease. Patients 18 years of age or older with Kaposi's sarcoma involving the skin may be eligible for this study. Participants will have photographs taken of their lesions and will undergo three imaging procedures (described below) at the beginning of the study (baseline) and then about once every 3 months or so while on the study (up to 2 years) to compare the test results over time. (Imaging may be done at more or less frequent intervals depending on the findings.) A small amount of blood (less than a tablespoon) will be drawn the day of each imaging procedure. Laser Doppler imaging This technique measures the amount of blood flow in KS lesions by scanning the lesions with a low-power laser beam. Each lesion takes about 3 minutes to scan. The imaging may be done before and after a blood pressure cuff around the arm is inflated for a short time (usually less than 30 seconds). Multi-spectral imaging This technique uses light to measure the total blood volume in each lesion and how much oxygen is in the blood. Oxygen is carried to the body s cells by a protein in red blood cells called hemoglobin. The light on the multi-spectral imaging instrument is absorbed differently depending on whether the hemoglobin has oxygen attached to it or not. It takes about 2 minutes to scan each lesion. Infrared thermal imaging This test uses a special camera to take digital infrared pictures of the skin. Images formed of the temperature of the KS lesions are used to assess blood flow in the lesions. This imaging takes about 1 minute per lesion. ...
This is a multicenter, randomized, single-blind pivotal study to evaluate the safety and efficacy of the MagicTouchTM Drug coated balloon in treatment of small vessels in patients with coronary artery disease. The objective is to establish the safety and efficacy of the Magic TouchTM Drug coated balloon in treatment of small vessels (≤2.75 mm). A total of 1605 subjects will be enrolled in a maximum of 50 study sites located in North America. Additional sites located in Europe and South America may also participate in the study, with non-US sites contributing a maximum of \~50% of enrollees.
COMPLETE-2 is a prospective, multi-centre, randomized controlled trial comparing a strategy of physiology-guided complete revascularization to angiography-guided complete revascularization in patients with acute ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI) and multivessel coronary artery disease (CAD) who have undergone successful culprit lesion Percutaneous Coronary Intervention (PCI). COMPLETE-2 OCT is a large scale, prospective, multi-centre, observational, imaging study of patients with STEMI or NSTEMI and multivessel CAD in a subset of eligible COMPLETE-2 patients.
The primary study objective of the NASA registry is to evaluate the 12-month incidence of target vessel failure (TVF) in patients who present with saphenous vein graft (SVG) lesions and undergo percutaneous coronary intervention (PCI) of the corresponding native coronary artery.
The ELEGANCE Registry's objective is to collect Real-World Data (RWD), including populations previously not represented in Peripheral Vascular Disease (PVD) trials, health economics data, and to support the safe use of commercially available Boston Scientific Corporation (BSC) drug-eluting devices for the treatment of lesions located in the peripheral vasculature.
The AV-MDR is a prospective, non-randomized, open-label, multi-center registry. The purpose of the AV-MDR study is to proactively collect and evaluate clinical data on the usage of the devices in scope within their intended use with the aim of confirming safety and performance throughout their expected lifetime, ensuring the continued acceptability of identified risks, detecting emerging risks on the basis of factual evidence, ensuring the continued acceptability of the benefit-risk ratio, and identifying possible systematic misuse or off-label usage such that the intended use can be verified as appropriate.
The NVS Therapy is being studied to evaluate the safety and efficacy to facilitate retention of acute luminal gain, leading to acute hemodynamic improvement in superficial femoral and popliteal arteries with reference vessel diameters between 4.0 and 7.0 mm and lesion lengths less than or equal to 56mm.
To help determine if there is improved pain relief when a device that makes an arm muscle move (nerve stimulator) is used to place a needle in the area above the collarbone to prevent feeling of pain (anesthesia) of the upper arm.
This study is designed to collect information during a procedure that is routine care for treating a blockage in a blood vessel in the upper part of the participant's leg. This study is for data collection reasons to help doctors gain better understanding of the treatment of disease in the blood vessels of the legs. You will be treated with two devices that are routine, or standard of care, for your doctor to treat blockages in the blood vessel of the leg. The treatment is for a blockage or narrowing caused by plaque build-up in the blood vessel. Data will be collected to assess what length of time the blood vessel will be prevented from re-narrowing through twenty-four (24) months after the procedure.
The purpose of this study is to evaluate the effectiveness of using Fluorescein Sodium and the Yellow 560 microscope to aid in treatment of intracranial tumors and vascular lesions.
Several studies have shown that stenting of the femoropopliteal artery in the lower leg leads to improved overall results compared to balloon angioplasty alone. However, scar tissue development can occur within the stent, a process called restenosis. Treatment of these in-stent restenotic lesions has a high procedural success rate but recurrence of scar tissue is frequently seen. Several methods have been proposed to treat in-stent restenosis in the lower leg arteries but mixed results have been noted. In this study we hypothesize that simultaneous tissue excision and aspiration using the JetStream Navitus device (Medrad) can lead to a high rate of acute procedural success with low intraprocedural complications and an acceptable recurrence rate of restenosis at 6-month follow-up.
To determine the safety and efficacy of the Omnilink Elite™ Peripheral Balloon-Expandable Stent System in subjects with atherosclerotic de novo or restenotic lesions in the native common iliac artery and/or native external iliac artery.
Background: * Tumors depend on blood vessels to provide the nourishment that allows them to grow. * Thyroid, parathyroid, adrenal gland and pancreatic neuroendocrine tumors are among the tumors that contain the most blood vessels. Thus, endocrine tumors are important for the study of new blood vessel formation in tumors. Objectives: -To obtain tissues from endocrine tumors for examination to determine how they differ from normal tissue. Eligibility: -Patients who are scheduled for surgery to remove an endocrine tumor, those in or around the thyroid, parathyroid, adrenal gland, pancreas, or any neuroendocrine tissue. Design: * Tissues will be obtained from patients during surgery to remove thyroid, parathyroid, adrenal, pancreas, or neuroendocrine tumors. * About 400 patients will be enrolled in the study over a period of 5 years.
The ORION study is being conducted to determine whether the Epic™ Nitinol Stent for primary stenting of iliac atherosclerotic lesions shows acceptable performance at 9 months.
To determine the safety and efficacy of the Absolute Pro™ Peripheral Self-Expanding Stent System in subjects with atherosclerotic de novo or restenotic lesions in the native common iliac artery and/or native external iliac artery.