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Found 6 Actively Recruiting clinical trials

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Actively Recruiting

Minimally invasive surgery has greatly changed surgical practices since the 1980s, especially in urology where laparoscopy and robot-assisted surgery have advanced treatment of conditions like prostate cancer. In France and other countries, robotic surgery became widespread without strong studies confirming its benefits or guidelines on quality and access. This trial aims to carefully evaluate robot-assisted prostate removal compared to traditional laparoscopic and open surgery techniques to provide clear evidence for patients and healthcare decision-makers. Participants will undergo radical prostatectomy using one of three approaches: robot-assisted laparoscopy, conventional laparoscopy, or open surgery (laparotomy). Urinary and erectile functions will be assessed before and after surgery to compare outcomes across the three groups. This large prospective study is conducted at multiple centers to gather reliable data on the benefits and impacts of each surgical method. During the study, patients will be evaluated for urinary function using the EPIC 50 score 45 days after surgery. Researchers will also assess erectile and urinary functions before and after the prostatectomy. The study focuses on understanding how each surgical technique affects recovery and function, helping to inform patients and health authorities about the real advantages of robot-assisted surgery. Participants must be hospitalized for planned radical prostatectomy and will be monitored throughout their treatment and recovery.

Age: 18Years +MALE
30 locations
C

Actively Recruiting

Researchers are investigating the use of CT scans before performing percutaneous coronary intervention (PCI) in patients with chronic total occlusion (CTO) of a coronary artery. CTO is a complete blockage of a coronary artery lasting more than 3 months and is common in about 20% of patients undergoing coronary angiography. The study focuses on complex cases with a J-CTO score of 2 or higher, aiming to see if CT scans can improve the success rate of the PCI procedure while reducing radiation exposure, contrast medium use, and procedure time. Participants are divided into two groups: one group will have a CT scan before their PCI procedure, while the other group will undergo PCI following standard care without a pre-procedure CT scan. The CT scans use a latest-generation 256-slice GE Revolution machine to better evaluate artery anatomy, calcium distribution, occlusion length, and other factors that may affect the procedure. This detailed imaging may help select the best PCI technique and equipment. During the study, patients will receive PCI treatment and researchers will monitor the immediate success of the procedure. They will evaluate factors such as radiation dose, contrast injection amount, procedure duration, and overall cost-efficiency. Success is measured immediately after surgery by the number of patients with a successful CTO PCI procedure. The study includes patients aged 18 to 90 years with complex CTO and viable heart muscle, and involves assessments including coronary angiography and clinical evaluations.

Age: 18Years - 90YearsAll GendersPhase Not Applicable
1 location
D

Actively Recruiting

Post-thrombotic syndrome (PTS) is a frequent long-term complication of deep vein thrombosis (DVT) that significantly affects patients' quality of life and increases healthcare costs. This research aims to study how the extent of blood clot burden in the veins, measured by a special ultrasound score called the Venous Volumetric Index (VVI), can predict the likelihood and severity of PTS six months after a first episode of symptomatic DVT in the lower limbs. Understanding these predictive factors could help guide better treatment strategies for patients at risk of developing PTS. The study is a multicenter prospective cohort design involving patients diagnosed with a first episode of symptomatic lower limb DVT confirmed by ultrasound. Participants will be followed with clinical assessments and ultrasound scans at one week (only for those in biological research), one month, three months, and six months after diagnosis. Blood samples will be collected at baseline, one week, one month, and three months to examine inflammation and blood clotting factors. Quality of life questionnaires will be completed at three and six months. The VVI score will be calculated from ultrasound data to quantify the clot burden, and the Villalta scale will be used to assess PTS severity over the six-month follow-up period. During each visit, symptoms and clinical signs related to PTS will be evaluated, and color Doppler ultrasound of the lower limbs will be performed. Blood tests will help explore biological markers linked to PTS development. Patients will complete questionnaires about their quality of life to assess the impact of symptoms. The study concludes with the six-month visit, at which point researchers will analyze the association between initial clot burden and PTS outcomes. This comprehensive follow-up aims to improve the prediction and understanding of PTS after DVT.

Age: 18Years +All GendersPhase Not Applicable
27 locations
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Actively Recruiting

Researchers are evaluating the Polymer-Free Sirolimus Eluting Coronary Stent System called Vivo ISAR in patients with coronary artery stenosis. The study aims to collect clinical outcome data in real-world patients with coronary artery disease, following standard care procedures. The goal is to assess results and safety with a 12-month follow-up after treatment. Participants receive treatment using the Vivo ISAR stent device, which is designed to improve blood flow by widening narrowed coronary arteries in patients with symptomatic ischemic heart disease. The study involves patients undergoing percutaneous coronary intervention, with the Vivo ISAR stent used exclusively when stenting one or more vessels. During the study, participants will be monitored for clinical outcomes including the rate of target lesion failure within 12 months after the procedure. Researchers will collect relevant data on health status and treatment effects as part of routine clinical practice. The study is observational and follows patients over a year to evaluate the device's performance and safety in everyday medical care.

Age: 18Years +All Genders
19 locations
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Actively Recruiting

This research aims to continuously evaluate and report on the safety and effectiveness of Medtronic products that are already available on the market. It addresses a wide range of conditions including cardiac rhythm disorders, neurological and cardiovascular disorders, digestive issues, respiratory therapy, and various surgical and diagnostic procedures. The registry supports patients, hospitals, clinicians, regulatory bodies, payers, and industry by simplifying the clinical monitoring process and enhancing performance assessment. Participants in this registry are those who have received or are planned to receive treatment with eligible Medtronic products. Enrollment can occur within a specific time window relative to starting therapy or retrospectively. The study does not involve specific interventions but focuses on the ongoing collection of data related to the products in use. During participation, individuals will be monitored periodically every 6 to 12 months depending on their therapy. Researchers will collect data to assess safety and effectiveness without additional procedures beyond standard care. Follow-up will continue as long as the therapy is ongoing, with the goal of providing long-term surveillance and valuable information to improve patient care and product performance.

All Genders
391 locations
P

Actively Recruiting

Researchers are investigating whether managing robot-assisted radical prostatectomy as an outpatient procedure is as safe as doing it as an inpatient procedure by comparing early post-operative complications. The study focuses on men with prostate cancer who have been recommended for this surgery and aims to confirm that outpatient care is not inferior to inpatient care in terms of complications occurring within the first 8 days after surgery. The intervention involves robot-assisted radical prostatectomy performed either as outpatient or inpatient care. Participants will undergo the surgical procedure and then follow the assigned care method. The study evaluates early complications occurring from the day of surgery up to 8 days afterward to determine safety and effectiveness between the two groups. Participants will visit the clinic once after the operation at 45 days, 6 months, and then yearly for up to 5 years for ongoing check-ups and tests. During the first 6 months, they will complete surveys on urinary and erectile functions, stress, anxiety, satisfaction, and quality of life. Additionally, participants will keep a diary to record procedures and treatments related to their care. These measures help researchers assess recovery, well-being, and long-term outcomes while monitoring safety throughout the study period.

Age: 18Years +MALEPhase Not Applicable
12 locations
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