Morges

Researchers are evaluating treatments for infrarenal abdominal aortic aneurysm AAA with wide proximal aortic neck diameters 28mm to 32mm. The trial compares clinical outcomes of two methods endosuture aneurysm repair ESAR and standard endovascular aneurysm repair EVAR. This randomized controlled trial aims to provide clinical evidence about the effectiveness of these approaches in patients with this specific aneurysm anatomy, addressing a current lack of comparative data. The study involves two groups one receiving EVAR using the Endurant IIIIs stent graft system alone, and the other receiving ESAR with the Endurant IIIIs stent graft plus the Heli-FX EndoAnchor system. Up to 300 participants will be enrolled across multiple sites in Europe and the US. Participants will be followed according to recommended guidelines and device instructions, with assessments at baseline, the procedure, 1 month, and annually for up to 5 years. During the study, participants will undergo clinical evaluations including CT imaging and other assessments at scheduled visits. Researchers will measure outcomes such as the composite proximal seal success at 1 year, freedom from type IA endoleak, migration, aneurysm sac growth, and neck dilatation. Safety and long-term effectiveness will be monitored through these follow-ups, providing detailed information about the treatments over time.

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.

Researchers are evaluating a wearable device designed to support balance and walking in adults with peripheral neuropathy. This trial aims to assess whether the device can improve gait stability and balance during daily activities while also examining its safety, comfort, and overall user acceptability. The study compares an active device with a sham inactive version in a controlled, randomized setting. Participants will be randomly assigned to use either the active wearable device or a sham device that lacks active functionality. They will use the device over a defined period to evaluate changes in gait and balance. The study includes weekly sessions and a home-use phase to monitor device performance and user experience. Both groups will be observed and assessed throughout the study to compare outcomes. Participants will attend weekly visits and perform home use of the device, with follow-up assessments up to 80 days. Researchers will measure changes in the Functional Gait Assessment score, timed-up-and-go test, neuropathic pain symptoms, quality of life, sensory function tests, fall risk, neuroimaging in some participants, and objective gait parameters like step length and heel-strike force. Treatment compliance and device usability will also be monitored to evaluate safety and effectiveness over the study period.