Study of Colorectal Procedures With the Levita Magnetic Surgical System

Levita Magnetics

Status

Completed

Conditions

Colorectal Procedures

Treatments

Device: Levita Magnetic Surgical System

Study type

Interventional

Funder types

Industry

Identifiers

NCT03960684

CP006

Details and patient eligibility

About

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

Full description

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

Enrollment

31 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 colorectal 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