A Study at Multiple Centers to Evaluate the Safety and Practicality of the Levita Magnetic Surgical System for Use in Laparoscopic Upper Gastrointestinal Surgeries.

Levita Magnetics

Status

Not yet enrolling

Conditions

Upper Gastrointestinal Laparoscopic Surgery

Treatments

Device: Levita Magnetic Surgical System

Study type

Interventional

Funder types

Industry

Identifiers

NCT07293611

LVT011

Details and patient eligibility

About

A Study at Multiple Centers to Evaluate the Safety and Practicality of the Levita Magnetic Surgical System for Use in Laparoscopic Upper Gastrointestinal Surgeries.

Enrollment

30 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

BMI range of 20 to 60kg/m2
Scheduled to undergo laparoscopic procedures
Willing and able to provide a written Informed Consent Form (ICF) to participate in the study prior to any study- required procedures

Exclusion criteria

Individuals with pacemakers, defibrillators, or other electromedical implants
Individuals with ferromagnetic implants
American Society of Anesthesiologists (ASA) score of III or IV
Significant comorbidities: cardiovascular, neuromuscular, chronic obstructive pulmonary disease, and urological disease (renal failure)
Clinical history of impaired coagulation confirmed by abnormal blood tests
Individuals who have signs of hepatic abnormality (e.g.: cirrhosis, liver failure, increase in liver enzymes, etc.)
Anatomical abnormality or disease of intended target tissue noted after initiation of index procedure that would prevent device use
Pregnant or wishes to become pregnant during the length of study participation
Individual is not likely to comply with the follow-up evaluation schedule
Participating in a clinical trial of another investigational drug or device
Prisoner or under incarceration