Saint Jean

Researchers are studying the management and follow-up of non-muscle-invasive bladder cancer (NMIBC), a type of bladder tumor that affects the inner lining and underlying tissue but not the muscle layer. This cancer type accounts for a significant portion of bladder cancer cases in France, with many patients experiencing tumor recurrence within five years. The study aims to evaluate the diagnostic accuracy of urine biomarker tests compared to bladder endoscopy, which is the current standard for detecting tumor recurrence. Additionally, it will describe tumor characteristics, patient history, treatments, and regional differences in care. Patients being monitored for NMIBC and undergoing routine care will have their medical details, including prior treatments and urine test results, recorded in a registry. Follow-up includes regular bladder endoscopy exams, with dates and findings noted by urologists. Urine test results taken before biopsies will also be tracked. This observational study will analyze the performance of urine tests by calculating sensitivity, specificity, and predictive values, and exploring differences based on tumor grade, stage, and previous treatments. The goal is to include 8000 patients across France over six years. Participants will provide data through medical records and routine exams during their personalized care plans. Urine samples and bladder fibroscopy results will be collected at each follow-up visit to assess test accuracy over a five-year period. Researchers will monitor recurrence-free survival and urine test performance, aiming to identify if urine tests can safely reduce the need for invasive cystoscopy. The study focuses on long-term monitoring to better understand and improve care for NMIBC patients.

Researchers are evaluating a new care pathway for men undergoing laser endoscopic enucleation of prostate adenoma, a treatment for benign prostatic hyperplasia that improves urination and quality of life. This procedure typically requires a hospital stay of at least 48 hours. The study explores whether early home return supervised by nurses can safely reduce hospitalization to just one night without increasing serious complications. The study involves supporting patients through nurse-led coordination before surgery and after they leave the hospital. The laser treatment uses different wavelengths to remove the prostate adenoma through the urethra. The new care pathway developed by the Union Clinique aims to shorten hospital stays by involving patients actively in their care and providing continuous nursing support at home. Participants will be monitored for hospital readmissions or extended hospital stays within two weeks after surgery. Nurses will oversee patient care coordination and rehabilitation during home return. The study tracks safety outcomes related to early discharge and evaluates whether this approach can be adopted by other healthcare centers, potentially improving recovery and reducing hospital time for patients.

This research collects long-term clinical data on patients who have had shoulder joint replacement or repair after shoulder trauma. It focuses on patients treated with one or more shoulder medical devices distributed by FH ORTHO SAS. The study is designed to meet European Medical Device Regulation requirements for post-market clinical follow-up by observing patients under usual surgical and follow-up conditions. Participants receive shoulder surgery using CE-marked FH ORTHO devices such as ARROW and ARROW prosthesis, Telegraph Evolution humeral nail, and STRAPFLEX strapping system. The study is non-interventional and permanent, aiming to gather data over 5 to 10 years depending on the device. Both retrospective and prospective patients from participating centers can be included. During the study, patients will have regular follow-up visits to monitor device performance and collect minimal clinical data. Researchers will assess long-term outcomes, safety, and device effectiveness up to 10 years. Participation involves completing questionnaires and allowing access to clinical information to document the benefit and risk profile of the devices over time.

Researchers are evaluating the potential of virtual reality to reduce pain during the endovenous thermal treatment of superficial varicose veins. This study aims to see if digital sedation using a virtual reality device can delay the need for neuroleptanalgesia, compared to the usual sedation methods. The trial is a prospective, randomized, open-label study involving 200 patients with superficial venous insufficiency. Participants will be divided into two groups: one using a device with virtual reality software for sedation, and the other receiving the usual neuroleptanalgesic treatment along with local anesthesia by tumescence. The study compares pain intensity during surgery between these two methods, accepting a small margin of difference to test whether virtual reality sedation is not worse than standard sedation. The treatment and assessments take place during a single outpatient surgical procedure. Participants will be monitored for pain intensity immediately after surgery using a numerical rating scale. The entire participation lasts up to 2 days. Researchers will assess maximum intraoperative pain and safety outcomes. The study includes measures to ensure participant understanding and consent, with a focus on tolerability and effectiveness of the digital sedation approach.

Researchers are conducting a prospective, multicenter, non-controlled, and non-randomized clinical study to evaluate the performance and stability of the SMS femoral stem implant. The study focuses on patients aged 18 to 75 years who have severely painful or disabling hip joint conditions such as osteoarthritis, traumatic arthritis, developmental hip dysplasia, or avascular necrosis of the femoral head, and who require total hip replacement surgery. Participants will undergo Total Hip Arthroplasty using the SMS Femoral Stem made by Medacta. This study does not involve randomization or control groups, and all patients will receive the same type of femoral stem implant. The treatment is surgical and the implant is uncemented. Throughout the study, researchers will monitor the survival rate of the SMS femoral stem from enrollment through the 10-year follow-up period. Participants will be asked to comply with study requirements, including signing a consent form and being affiliated with a social security system. The study will assess implant stability, performance, and long-term outcomes over a decade.

This research monitors the performance of the GMK4 SpheriKA Knee Prosthesis, which is implanted using the kinematic alignment technique. The study focuses on patients who need a primary total knee replacement due to arthropathy or knee replacement conditions. It aims to collect both clinical and radiological data to evaluate how well this knee prosthesis works after surgery. Participants will receive the GMK4 SpheriKA knee prosthesis implanted with the kinematic alignment method. The study will observe patients over time to assess their joint function and comfort using the Forgotten Joint Score (FJS). Follow-up evaluations will be conducted starting at 6 weeks post-surgery and then annually for up to 10 years to monitor outcomes and prosthesis performance. During the study, participants will undergo clinical and radiological assessments to gather data on their knee function and any changes over time. They will be required to comply with follow-up visits, including postoperative weight-bearing restrictions and self-evaluations. Researchers will measure the primary outcome using the Forgotten Joint Score at specified intervals to understand joint awareness during daily activities and track long-term safety and effectiveness of the knee prosthesis.