Clinical Evaluation of the Levita Robotic Platform

Clinical Evaluation of the Levita Robotic Platform

The purpose of this study is to evaluate the safety and feasibility of the Levita Robotic Platform (LRP) used with the Levita Magnetic Surgical System (MSS)

Prospective, multi-center, single-arm, open label study designed to assess the safety and feasibility of the use of the Levita Robotic Platform with the Levita Magnetic Surgical System in laparoscopic procedures.

Inclusion Criteria:

• • Subject is at least 18 years of age

  • Subject is scheduled to undergo elective laparoscopic procedure
  • Subject signs a written Informed Consent Form (ICF) to participate in the study prior to any study required procedures

Exclusion Criteria:

• • Subjects with pacemakers, defibrillators, or other electromedical implants

  • Subjects with ferromagnetic implants
  • Subjects with significant comorbidities: cardiovascular, neuromuscular, chronic obstructive pulmonary disease, and urological disease (renal failure)
  • Subjects with a clinical history of impaired coagulation confirmed by abnormal blood tests
  • Subject has an anatomical abnormality or disease of intended target tissue noted after initiation of index procedure that would prevent device use
  • Subject is pregnant or wishes to become pregnant during the length of study participation
  • Subject is not likely to comply with the follow-up evaluation schedule
  • Subject is participating in a clinical trial of another investigational drug or device