Simbionix Initiates Trial to Evaluate PROcedure Rehearsal Studio in AAA Treatment

Cleveland, Ohio-based Simbionix, a provider of clinical training technology, has started a trial to evaluate its PROcedure Rehearsal Studio as a platform for the treatment of abdominal aortic aneurysms with endovascular aortic repair (EVAR).

The “REHEARSAAAL” study will be conducted by multidisciplinary group of physicians from vascular surgery, interventional radiology and cardiology departments in hospitals across the United States and Europe.

PROcedure Rehearsal Studio allows physicians to create a 3-D anatomical model based on a patient’s individualized CT scan to simulate, analyze and evaluate preoperative surgical options. The availability of patient-specific technology allows the interventional team to engage in simulated practice procedures using a patient’s own anatomy prior to performing an actual procedure, potentially leading to more precise treatment decisions, a reduction of errors, improved outcomes, and enhanced operator confidence, according to the company. Prior case simulation may allow patients to have a shortened procedure with less time under sedation, a reduction in radiation exposure, and a decrease in procedural complications.

This two-arm study will randomize 150 patients in 1:1 ratio, stratified by operator’s experience and procedure complexity. It compares real EVAR procedure parameters with an emphasis on radiation exposure time and safety parameters. Physicians treating patients enrolled for the preoperative patient specific simulation group will go through the simulated experience—a virtual practice session—prior to performing the real case.  Outcomes in these patients will be compared to procedures performed without prior simulated practice as is routinely done.

John Rundback, M.D., medical director of the Interventional Institute at Holy Name Medical Center in Teaneck, N.J., and the study’s principal investigator, said: “Simulation has proven experience in the aviation and other industries in improving performance and reducing errors. The Simbionix PROcedure Rehearsal Studio provides a platform to practice and optimize procedures using personalized patient data in advance of performing live cases, assuring an unparalleled opportunity to streamline all aspects of the actual procedure, improve patient safety, and reduce the use of additional costly devices that are often needed when procedures are unable to be rehearsed.”