Clinical Evaluation of the Levita Robotic Platform

Levita Magnetics

Status

Completed

Conditions

Bariatric Surgery Candidate

Other Disease

Cholelithiases

Treatments

Device: Levita Robotic Platform

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT05353777

CP007

Details and patient eligibility

About

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)

Full description

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.

Enrollment

48 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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