Safety and Feasibility of the Use of the Dual Robotic Arm Accessory With the Levita Magnetic Surgical System in Laparoscopic Procedures (MARS GI)

Levita Magnetics

Status: Completed

Conditions: Bariatric Surgery Candidate; Other Disease; Cholelithiases

Treatments: Device: Dual Robotic Arm Accessory (DRAA)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05695989

CP008

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and feasibility of the Levita Dual Robotic Arm Accessory (DRAA) 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 Dual Robotic Arm Accessory with the Levita Magnetic Surgical System in laparoscopic procedures

Enrollment: 22 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 Prisoner or under incarceration

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

DRAA (Dual Robotic Arm Accessory)

Experimental group

Description:

Levita has developed a Robotic Platform (DRAA) to assist in external management of the controlling magnet and the laparoscopic camera, which would give better control of surgical tools to the surgeon.

Treatment:

Device: Dual Robotic Arm Accessory (DRAA)