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Found 2 Actively Recruiting clinical trials

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Researchers are evaluating a magnetic-assisted surgical technique for revisional bariatric surgery, specifically converting sleeve gastrectomy to Roux-en-Y gastric bypass RYGB combined with hiatoplasty. This approach addresses long-term problems such as gastroesophageal reflux disease GERD in patients who have undergone laparoscopic gastric sleeve LGS surgery. The study aims to assess the surgical procedure and its outcomes in patients who are candidates for bariatric surgery with obesity. The surgery is performed using magnetic assistance to improve visualization and manipulation during key steps. It involves placing a single port in the umbilicus and an additional trocar, using magnets for liver retraction, dividing the omentum, repairing hiatal hernia, creating the gastric pouch, measuring and connecting intestinal limbs, and closing defects. A methylene blue leak test is done to check for leaks, and the entire Roux-en-Y gastric bypass is completed with magnet-assisted maneuvers. Participants undergo this bariatric procedure with magnetic assistance and are monitored for complications within 30 days, device malfunction within 1-2 hours post-procedure, and surgical time within 30 days. The study includes evaluations of surgical field exposure, anastomosis construction, and hernia repair. The total participation timeline includes the surgical procedure and follow-up assessments up to 30 days after surgery.

Age: 18Years - 65YearsAll Genders
1 location
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Actively Recruiting

Researchers are investigating management strategies for masked uncontrolled hypertension to see if using out-of-office blood pressure BP monitoring improves health outcomes compared to office BP measurements. This 4-year, prospective, randomized, open-label, blinded-endpoint study PROBE aims to compare cardiovascular and kidney-related results between these two approaches. The study will recruit 1240 adults aged 35 to 80 years and is sponsored by Istituto Auxologico Italiano. Participants are randomly assigned to one of two groups one using office BP to guide antihypertensive treatment and the other using 24-hour ambulatory BP monitoring ABPM to guide treatment. The study includes a 12-month period focusing on changes in left ventricular mass index LVMI and urinary albumin excretion UAE, with follow-up continuing for a total of 48 months to observe cardiovascular events, mortality, and other health changes. During the study, participants will have their BP management optimized according to their assigned group. Researchers will assess blood pressure-related variables, LVMI, and UAE at one year and monitor cardiovascular and cerebral events through the full 4 years. The study measures these co-primary endpoints at 12 months and collects outcome data on mortality and morbidity over 48 months, ensuring thorough evaluation of each management strategys effects.

Age: 35Years - 80YearsAll GendersPhase Not Applicable
2 locations