Evaluation of a Venous-Return Assist Device (Venowave) to Treat Post-Thrombotic Syndrome: A Randomized Controlled Trial
The purpose of this study is to determine whether daily use of a lower limb venous-return assist device, "Venowave', improves leg symptoms, ability to perform activities of daily living, and quality of life in subjects with severe PTS.
Eligible consenting patients will be randomly allocated to receive either the veno-device (active or placebo for 8 weeks and crossed over for a further 8 weeks (active or placebo) following a 4 week 'wash out' period.( A randomized controlled 'crossover' study}
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Henderson Research Centre
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT00182208
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
A condition characterized by a chronically swollen limb, often a leg with stasis dermatitis and ulcerations. This syndrome can appear soon after phlebitis or years later. Postphlebitic syndrome is the result of damaged or incompetent venous valves in the limbs. Distended, tortuous VARICOSE VEINS are usually present. Leg pain may occur after long period of standing.
Pulmonary Veno-occlusive Disease
Pathological process resulting in the fibrous obstruction of the small- and medium-sized PULMONARY VEINS and PULMONARY HYPERTENSION. Veno-occlusion can arise from fibrous proliferation of the VASCULAR INTIMA and VASCULAR MEDIA; THROMBOSIS; or a combination of both.
Safety-based Medical Device Withdrawals
Removal of a MEDICAL DEVICE from the market due to the identification of an intrinsic property of the device that results in a serious risk to public health.
Medical Device Recalls
Removal of a MEDICAL DEVICE from the market due to a problem occurring in the manufacture or distribution of the product.
Intrauterine Device Migration
The shifting in position or location of an INTRAUTERINE DEVICE from its original placement.
The purpose of this study is to (1) demonstrate the efficacy and safety (toxicity) of 25 mg/kg/day of Defibrotide in patients with severe veno-occlusive disease (sVOD) and (2) evaluate ser...
Continuous veno-venous hemodiafiltration is widely used in the treatment of patients with acute renal failure. Two techniques for CVVHDF are coexisting in this hospital: classical CVVHDF a...
Veno-occlusive disease (VOD) of the liver is a significant complication for some patients undergoing hematopoietic stem cell transplantation. This disease is thought to be a toxicity secon...
The aim of this trial is to evaluate whether the prophylactic use of Defibrotide (DF) in pediatric patients (age less than 18 years) undergoing stem cell transplantation and who are at hig...
The investigators will test whether breathing through an inspiratory resistance device will improve the ability to be upright and decrease heart rate increases on standing in patients with...
A 6-year-old boy had cold-like symptoms and was diagnosed with influenza A at a clinic. Administration of oseltamivir and azithromycin did not improve the symptoms. He was referred to our hospital and...
We report on a 49-year-old male patient who suffered from severe herpes simplex (HSV) pneumonia after a fall-from-height injury, causing a circumscript type B aortic dissection. The subsequent occurre...
Bicaval dual lumen catheters improve the efficiency of veno-venous extracorporeal membrane oxygenation by minimizing recirculation with an innovative design, which requires precise placement of three...
Device closure of atrial septum defect was performed using an Amplatzer septal occluder in a 48-year-old patient with Marfan syndrome. Acute tamponade due to perforation was observed 2 months after c...
Prophylactic use of defibrotide (DF) to prevent veno-occlusive disease (VOD), a relatively common and high-risk complication of hematopoietic stem cell transplantation (HSCT), may be an encouraging mo...