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Found 3 Actively Recruiting clinical trials
Actively Recruiting
Healthy Volunteer
This research focuses on patients with obesity and gastroesophageal reflux disease (GERD) who are candidates for bariatric surgery. It evaluates a revisional surgical technique using magnetic assistance to convert from sleeve gastrectomy to Roux-en-Y gastric bypass (RYGB) combined with hiatoplasty. RYGB is considered a strong option for significant weight loss and resolving comorbidities, and this study aims to address long-term GERD issues following previous surgeries. The procedure is performed by an experienced bariatric surgeon using a single-port approach with magnetic tools to assist in various steps. These steps include liver retraction, division of the omentum, hiatal hernia repair, creation of the gastric pouch, and anastomosis construction. Magnetic assistance is also used to close defects and complete the surgery efficiently. The operation includes routine leak testing and measures specific intestinal limb lengths. Participants will undergo this magnetic-assisted surgical procedure and be closely monitored for complications within 30 days, device malfunctions during surgery, and total surgical time. The study includes assessments of surgical outcomes and safety to ensure proper evaluation of this revisional technique. Participant involvement includes preoperative evaluation and postoperative follow-up within the first month to track results and any adverse events.
Actively Recruiting
Healthy Volunteer
This research evaluates the use of a magnetic system as a second surgical assistant in bariatric and general surgeries, beyond its previous use limited to liver retraction. It focuses on patients undergoing primary laparoscopic sleeve gastrectomy, one-anastomosis gastric bypass, Roux-en-Y gastric bypass, revisional surgery with single-port or reduced-port approaches, and other procedures such as Nissen/Sleeve gastrectomy and general surgery. The study aims to demonstrate the safety and practicality of using magnetic devices in these surgical steps to improve outcomes and aesthetic results. The interventions involve performing various surgical procedures with the assistance of a magnetic grasper. This device helps with liver retraction, upper retraction of the stomach, gallbladder retraction in cholecystectomies, closure of mesenteric defects, and other tasks typically requiring a second assistant. Procedures studied include magnetic gastric bypass, magnetic sleeve gastrectomy, revisional bariatric surgery, Nissen/Sleeve gastrectomy with magnetic assistance, and magnetic general surgery. The magnetic system is applied during key steps to aid tissue manipulation and defect closure. Participants will be monitored for surgical complications, surgery duration, and issues related to the magnetic system. Researchers will assess outcomes such as the effectiveness of the magnetic grasper acting as a second assistant. The study measures these outcomes during and shortly after the 1-2 hour surgical procedures, tracking the rate of surgical and magnetic system-related complications. This monitoring helps evaluate the device's safety and potential benefits in bariatric and general surgery contexts.
Actively Recruiting
Researchers are evaluating two strategies for managing masked uncontrolled hypertension by comparing treatment guided by office blood pressure (BP) measurements versus 24-hour ambulatory blood pressure monitoring (ABPM). This 4-year, prospective, randomized, open-label study involves 1240 participants and aims to assess differences in cardiovascular and kidney-related outcomes, including changes in heart muscle mass and urinary albumin levels. The study also tracks cardiovascular events and mortality over the full 48 months. Participants are randomly assigned to one of two groups: optimization of antihypertensive treatment based on office BP or based on 24-hour ABPM. Treatment adjustments are guided by the respective BP measurement method. The initial year focuses on changes in left ventricular mass index (LVMI) and urinary albumin excretion (UAE) as co-primary endpoints. Follow-up continues for four years to monitor these markers and track cardiovascular and cerebral health events, including mortality. During the study, participants will undergo regular blood pressure assessments and monitoring of heart and kidney health markers. Outcomes measured include changes in LVMI and UAE at 12 months, with ongoing evaluation of cardiovascular events, all-cause mortality, and related health changes through 48 months. The study is designed to gather comprehensive data to understand the impact of BP monitoring methods on health outcomes in people with masked hypertension.