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Found 5 Actively Recruiting clinical trials
Actively Recruiting
Researchers are studying prostate cancer patients undergoing radical prostatectomy to compare three surgical methods robot-assisted laparoscopy, conventional laparoscopy, and laparotomy. The study aims to evaluate the impact of these techniques on urinary and erectile functions, as well as their cost-effectiveness and long-term outcomes. This large, multicenter prospective observational study responds to previous concerns about the lack of high-quality evidence for robot-assisted surgery in prostate cancer treatment. Participants will undergo one of the three prostatectomy procedures robot-assisted laparoscopy, conventional laparoscopy, or laparotomy. Urinary and erectile functions will be assessed before and after surgery using standardized scores like the EPIC 50 and the International Index of Erectile Function IIEF-5. Outcomes including urinary incontinence, erectile dysfunction, and prostate-specific antigen PSA levels will be followed for up to five years. Cost-effectiveness will be evaluated at 12 months using the EQ5d-5L score. Throughout the study, participants will be evaluated at multiple time points, including 45 days and up to five years after surgery, to monitor urinary and erectile functions and other prostatectomy-related effects. Assessments involve questionnaires and clinical measurements. This comprehensive follow-up is designed to help determine the benefits and risks of each surgical approach, supporting informed decisions for patients and healthcare authorities. The study excludes patients without French health insurance or those unable to consent, focusing on adult males scheduled for prostatectomy.
Actively Recruiting
This research aims to study people who have had their first episode of symptomatic deep vein thrombosis DVT in their lower limbs to understand the risk and severity of post-thrombotic syndrome PTS, the most common long-term complication of DVT. The study focuses on evaluating how the amount of thrombosis blood clot burden measured by the Venous Volumetric Index VVI on ultrasound relates to the development and severity of PTS assessed by the Villalta scale over 6 months. Participants will be followed at multiple times around 1 week, 1 month, 3 months, and 6 months after diagnosis. At each visit, doctors will assess symptoms and signs to calculate the Villalta score and perform venous ultrasounds to measure thrombosis burden using the VVI. Blood samples will be collected at several visits to study inflammation, coagulation, and clot breakdown factors. Quality of life questionnaires will also be completed at 3 and 6 months. During the study, symptom assessments, ultrasound exams, blood tests, and questionnaires will help researchers understand how the thrombosis burden at baseline and over time relates to the occurrence and severity of PTS. The study ends with the 6-month visit. Researchers will monitor the presence of moderate to severe PTS and changes in clot burden to identify important prognostic factors that may guide future prevention and treatment strategies.
Actively Recruiting
This observational study evaluates the Polymer Free Sirolimus Eluting Coronary Stent System, known as the Vivo ISAR, in everyday clinical practice for patients with coronary artery stenosis. The purpose is to collect real-world data on clinical outcomes over a 12-month follow-up period, focusing on patients who receive this stent system as part of their routine care. The study is sponsored by Translumina GmbH and involves standard procedures and medications with known safety profiles. Participants will be treated with the Vivo ISAR stent during percutaneous coronary intervention to improve coronary artery diameter in those experiencing symptoms of ischemic heart disease. The study monitors patients who receive the stent in one or multiple vessels, observing their progress without altering standard care practices. The follow-up extends to 12 months after the procedure to assess various success rates and treatment effects. During the study, participants undergo routine clinical evaluations including assessments of device and procedural success shortly after treatment, and measures of target lesion failure and reperfusion at 12 months. Researchers also evaluate antiplatelet therapy adherence and effectiveness. The total participation involves regular check-ups and data collection to understand long-term outcomes and safety of the Vivo ISAR stent system in typical healthcare settings.
Actively Recruiting
This registry study is designed to continuously evaluate and periodically report the safety and effectiveness of Medtronic medical products that are already available on the market. It aims to support patients, hospitals, clinicians, regulatory bodies, payers, and industry by simplifying clinical surveillance and promoting advanced performance assessments with minimal burden. Participants include patients who have or are planned to receive an eligible Medtronic product. Enrollment can occur at any time relative to therapy start or retrospectively. The study involves ongoing data collection related to the use of these products in routine clinical care. Throughout participation, patients are monitored for safety and effectiveness outcomes approximately every 6 to 12 months, depending on the therapy. Data gathered helps assess product performance over time while minimizing additional visits or procedures. Follow-up continues until the studys completion, which extends to the year 2040.
Actively Recruiting
This clinical trial focuses on men with prostate cancer who are candidates for radical prostatectomy. It aims to compare outpatient versus inpatient robot-assisted radical prostatectomy to determine if managing the procedure as an outpatient leads to similar rates of early post-operative complications. The study evaluates early recovery outcomes and overall patient experience after surgery. Participants will undergo robot-assisted radical prostatectomy either as outpatients or inpatients. The trial compares these two approaches by monitoring early complications from the day of surgery up to eight days afterward. Additional outcomes evaluated include surgery duration, blood loss, recovery of urinary and erectile function, stress and anxiety levels around surgery, patient satisfaction, and longer-term follow-up for up to five years. During the study, participants will visit the clinic at 45 days, 6 months, and annually up to 5 years for check-ups and tests. They will complete surveys on urinary and erectile function, stress, anxiety, satisfaction, and quality of life for six months. Participants are also asked to keep diaries recording treatments and care procedures. Researchers will track hospital readmissions, complications, and economic and social costs related to patient care throughout the follow-up period.