Prospective Clinical Study of the Levita Magnetics Surgical System Used for Prostatectomy Surgery

Prospective Clinical Study of the Levita Magnetics Surgical System Used for Prostatectomy Surgery

The purpose of this study is to evaluate the safety and effectiveness of the Levita Magnetic Surgical System in patients undergoing prostatectomy surgery.

Prospective, multicenter, single-arm, open label study designed to assess the safety and effectiveness of the Levita Magnetic Surgical System in prostatectomy surgery.

Inclusion Criteria:

• Subject is at least 18 years of age
• Subject is scheduled to undergo elective prostatectomy surgery

Exclusion Criteria:

• Significant comorbidities
• Subjects with pacemakers, defibrillators, or other electromedical implants
• Subjects with ferromagnetic implants
• Clinical history of impaired coagulation
• Subject has an anatomical abnormality noted after initiation of index procedure that would prevent device use
• Subject is not likely to comply with the follow-up evaluation schedule
• Subject is participating in another clinical trial