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

NCT ID: NCT05695989

Last Updated: 2025-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-19
• Study Completion Date: 2023-03-08

Brief Summary

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)

Detailed 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

Conditions

Bariatric Surgery Candidate; Cholelithiases; Other Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DRAA (Dual Robotic Arm Accessory)

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.

Group Type: EXPERIMENTAL

Dual Robotic Arm Accessory (DRAA)

Intervention Type: DEVICE

Dual Robotic Arm Accessory (DRAA)

Interventions

Dual Robotic Arm Accessory (DRAA)

Dual Robotic Arm Accessory (DRAA)

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: collaborator

Levita Magnetics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julio Jimenez, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Tisne

Locations

Hospital Tisne

Santiago, Santiago Metropolitan, Chile

Clinica Colonial

Santiago, , Chile

Hospital Fach

Santiago, , Chile

Countries

Chile

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CP008

Identifier Type: -

Identifier Source: org_study_id