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IOPS Technology During Cannnulation of Contralateral Limb in EVAR
Sponsor: Clinical Centre of Serbia
Summary
Short-term results are favorable for EndoVascular Aneurysm Repair (EVAR) compared to open surgery. One of the major drawbacks to this shift is the need for fluoroscopy and contrast dyes to visualise endovascular devices. The use of fluoroscopy exposes both patients and caregivers to harmful ionizing radiation. Because of the harmful effects of radiation, recent radiation protection guidelines strongly recommend as low as reasonably achievable (ALARA) principle. The need for additional radiation-reducing navigation techniques is high, with the ultimate goal of performing endovascular procedures without radiation at all. In response to these challenges, Centerline Biomedical (Cleveland, Ohio, USA) has developed a proprietary electromagnetic tracking and positioning system called the Intra-Operative Positioning System (IOPS). This medical device provides surgeons with 3D visualization for increased surgical precision while reducing the radiation exposure for patients and healthcare professionals. IOPS provides 3D electromagnetic navigation of interventional devices as an adjunct to fluoroscopy. During the intervention, the IOPS devices can be visualized with on-screen image guidance. The IOPS guidewires and catheters can be used together or combined with off-the-shelf 0.035-inch catheters and guidewires, as needed. This study aims to describe the influence of IOPS technology on radiation exposure during cannulation of the contralateral limb (CL) during standard EVAR.
Official title: Contralateral Limb Cannulation Using Intra-Operative Positioning SystemTechnology in Endovascular Aneurysm Repair
Key Details
Gender
All
Age Range
40 Years - 100 Years
Study Type
OBSERVATIONAL
Enrollment
80
Start Date
2025-01-20
Completion Date
2025-11-03
Last Updated
2024-11-20
Healthy Volunteers
No
Interventions
Intra-Operative Positioning System (IOPS)
This medical device provides surgeons with 3D visualization for increased surgical precision while reducing the use of contrast dye and radiation exposure for patients and healthcare professionals alike. IOPS provides 3D electromagnetic navigation of interventional devices as an adjunct to fluoroscopy. During the intervention, the IOPS devices can be visualized with on-screen image guidance. The console is operated by a technician under a physician's instruction. The IOPS guidewires and catheters can be used together or combined with off-the-shelf 0.035-inch catheters and guidewires, as needed.
Conventional group
This group will be treated using standardised materials (wires, catheters) during EVAR.
Locations (1)
Clinical Center of Serbia
Belgrade, Belgrade, Serbia