Beaumont

Researchers are evaluating the effectiveness and safety of combining sonrotoclax with either obinutuzumab or rituximab compared to venetoclax plus rituximab in adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma CLLSLL. This Phase 3 randomized study aims to understand which combination offers better progression-free survival and treatment outcomes in patients who have undergone prior therapies. The study has four treatment groups sonrotoclax combined with obinutuzumab, sonrotoclax combined with rituximab, sonrotoclax plus obinutuzumab with treatment guided by minimal residual disease evaluation, and venetoclax combined with rituximab. Sonrotoclax and venetoclax are given orally, while obinutuzumab and rituximab are administered intravenously. Participants receive these treatments according to their assigned group as part of this clinical research. Participants will be monitored for progression-free survival, overall survival, response rates, and minimal residual disease status over several months up to several years. Safety assessments include tracking treatment-emergent adverse events. Quality of life and symptom burden will be evaluated using questionnaires. The study involves regular visits for treatment administration and assessments, with follow-up extending up to 84 months to observe long-term outcomes.

Researchers are evaluating the effectiveness and safety of two fixed-duration treatment combinations for adults with previously untreated chronic lymphocytic leukemia CLL. The study compares sonrotoclax plus zanubrutinib with venetoclax plus acalabrutinib to determine which regimen may better manage this condition. This Phase 3 trial aims to provide insights into these oral therapies for CLL patients needing initial treatment. Participants will be randomly assigned to receive either sonrotoclax and zanubrutinib or venetoclax and acalabrutinib. Both treatment groups will follow a fixed duration of therapy, after which participants will be observed without active treatment. The study drugs are taken orally, and the treatment period is followed by a monitoring phase to evaluate ongoing health. During the study, participants will undergo evaluations including imaging tests to measure disease status and assessments of bone marrow and organ function. Researchers will track progression-free survival and minimal residual disease levels up to about 70 months. Other outcomes such as overall survival, response rates, adverse events, and quality of life will also be monitored. The total study duration extends until November 2031, offering long-term follow-up for participants.

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.

Researchers are evaluating the FHK-CK knee prosthesis designed for complex first-time and revision knee replacement surgeries, addressing the growing need due to increasing life expectancy and the widespread use of total knee arthroplasty. This device aims to complement the existing FHK standard prosthesis range, providing surgeons with a versatile and reliable option to improve patient mobility and quality of life. The study is a pilot evaluation focusing on performance and safety with a follow-up period of two years. The study involves implanting the FHK-CK prosthesis, which is a class III medical device not yet CE-marked, along with specialized instruments developed by expert surgeons. The prosthesis is intended for patients with primary or secondary gonarthrosis requiring complex knee arthroplasty or revision surgery after a failed first implant. Surgery will be conducted following established guidelines and specific instructions for the device, with assessments at multiple time points up to 24 months after implantation. Participants will be assessed for functional performance before surgery and at 6 weeks, 6 months, 12 months, and 24 months post-surgery. Additional evaluations include monitoring adverse events, revision rates, device deficiencies, patient and surgeon satisfaction, and quality of life at scheduled intervals. The study also ensures participants can understand and respond to questionnaires, with outcomes tracked over approximately two years to determine the prosthesiss tolerance and overall impact.

Researchers are evaluating the safety and performance of the SYMBOL range of medical devices used in total hip arthroplasty hip replacement surgery. This observational study aims to monitor outcomes over a period of 10 years in patients who receive these devices, assessing their durability and overall impact on hip joint health. The study is sponsored by Dedienne Sante S.A.S. and focuses on conditions such as degenerative hip joint disease, post-traumatic osteoarthritis, hip arthritis, femoral neck fractures, avascular necrosis of the femoral head, and failure of prosthetic joint implants. Participants undergo total hip arthroplasty involving at least one medical device from the SYMBOL range. The study includes patients receiving either primary or revision hip replacement surgery with these devices. There is no randomized assignment or placebo group, as this is an observational follow-up of patients treated with SYMBOL devices. The study spans up to 10 years post-operation, with specific evaluation timepoints at 6 months, 18 months, 5 years, and 10 years after surgery. During the study, participants will have regular assessments including radiographic evaluations to check for implant stability and bone changes, as well as clinical evaluations using the Harris Hip Score and pain intensity scales. Patient-reported measures such as quality of life EQ-5D-5L and satisfaction with the hip joint will also be collected. The main outcome measure is the survivorship of individual SYMBOL orthopaedic components 10 years after surgery. Safety will be monitored by recording any adverse device effects throughout the study period, with follow-up lasting an average of 10 years.

Rotator cuff injuries affect about 30% of the general population, and when repair fails, patients often suffer persistent pain. During revision surgeries, bacteria can be found in about 30% of cases without clear infection signs, known as low-level infections, which may contribute to poor outcomes. This study investigates the impact of unexpected positive cultures UPC found during rotator cuff re-intervention and aims to determine how these cultures influence clinical outcomes and tendon healing. The research compares two groups of patients undergoing rotator cuff revision those with positive microbiological samples and those with negative samples taken during surgery. The study involves collecting and analyzing bacteriological samples from operative elements like sutures and tendon tissue during the re-intervention. Antibiotics are not given immediately after surgery or during the first month unless a pathogenic microorganism is identified, in which case antibiotic treatment starts and the participant discontinues the study. Participants will be followed at 1 month, 3 months, 6 months, and 1 year after surgery. Assessments include shoulder functional recovery, tendon healing using MRI-based Sugaya scores, occurrence of post-operative complications, and identification of pathogenic bacteria. Questionnaires and clinical evaluations will track outcomes, with safety and healing monitored over the year to understand the influence of positive cultures on recovery.